Back to resultsAbuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Primary Purpose
Nondependent Opioid Abuse, Episodic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
MS Contin (morphine sulfate, controlled release)
EMBEDA (morphine sulfate / naltrexone hydrochloride)
Sponsored by
About this trial
This is an interventional basic science trial for Nondependent Opioid Abuse, Episodic focused on measuring abuse potential, abuse liability, recreational opioid use, morphine
Eligibility Criteria
Inclusion Criteria:
- Subject is a recreational opioid user who is NOT physically dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, and the Naloxone Challenge. A recreational opioid user is defined as recreationally abusing opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to Visit 1.
- Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
- Has a history or current diagnosis of substance dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
- Has participated in, is currently participating in, or is seeking treatment for substance- and/or alcohol-related disorders (excluding nicotine and caffeine).
- History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
- Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.
- Has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus).
- Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.
Sites / Locations
- Lifetree Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo
MS Contin (morphine sulfate, controlled release)
EMBEDA (morphine sulfate / naltrexone hydrochloride)
Arm Description
Outcomes
Primary Outcome Measures
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).
Drug Liking: Peak Effect (Emax)
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.
High: Area Under Effect Curve (AUE) From 0-2 Hours
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
High: Peak Effect (Emax)
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Secondary Outcome Measures
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Drug Liking: Time to Maximum (Peak) Effect (TEmax)
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). TEmax = Time to maximum observed score.
High: Area Under Effect Curve (AUE) From 0-1 Hour
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
High: Area Under Effect Curve (AUE) From 0-4 Hours
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
High: Area Under Effect Curve (AUE) From 0-8 Hours
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
High: Area Under Effect Curve (AUE) From 0-12 Hours
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
High: Area Under Effect Curve (AUE) From 0-24 Hours
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
High: Time to Maximum (Peak) Effect (TEmax)
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Good Effects: Peak Effect (Emax)
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Good Effects: Time to Maximum (Peak) Effect (TEmax)
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Any Effects: Peak Effect (Emax)
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Any Effects: Time to Maximum (Peak) Effect (TEmax)
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Bad Effects: Peak Effect (Emax)
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Bad Effects: Time to Maximum (Peak) Effect (TEmax)
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Nausea: Area Under Effect Curve (AUE) From 0-4 Hours
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Nausea: Area Under Effect Curve (AUE) From 0-8 Hours
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Nausea: Area Under Effect Curve (AUE) From 0-12 Hours
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Nausea: Area Under Effect Curve (AUE) From 0-24 Hours
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Nausea: Peak Effect (Emax)
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Nausea: Time to Maximum (Peak) Effect (TEmax)
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Feel Sick: Peak Effect (Emax)
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Feel Sick: Time to Maximum (Peak) Effect (TEmax)
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Sleepy: Peak Effect (Emax)
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Sleepy: Time to Maximum (Peak) Effect (TEmax)
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Dizzy: Peak Effect (Emax)
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Dizzy: Time to Maximum (Peak) Effect (TEmax)
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Overall Drug Liking Effect at 24 Hours
Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").
Take Drug Again Effect at 24 Hours
Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Pupillometry: Peak Effect (Emax)
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.
Pupillometry: Time to Maximum (Peak) Effect (TEmax)
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine
Maximum Observed Plasma Concentration (Cmax) of Morphine
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine
AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine
AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine
AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine
AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine
AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine
AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone
Maximum Observed Plasma Concentration (Cmax) of Naltrexone
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone
AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone
AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone
AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone
AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone
AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone
AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)
Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)
AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)
AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)
AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)
AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)
AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)
AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01380093
Brief Title
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Official Title
A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study to Determine the Abuse Potential of Oral Administration of Crushed EMBEDA Relative to Crushed Controlled-Release Morphine Sulfate and Placebo in Non Dependent, Recreational Opioid Users
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nondependent Opioid Abuse, Episodic
Keywords
abuse potential, abuse liability, recreational opioid use, morphine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
MS Contin (morphine sulfate, controlled release)
Arm Type
Active Comparator
Arm Title
EMBEDA (morphine sulfate / naltrexone hydrochloride)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage
Intervention Type
Drug
Intervention Name(s)
MS Contin (morphine sulfate, controlled release)
Intervention Description
Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
Intervention Type
Drug
Intervention Name(s)
EMBEDA (morphine sulfate / naltrexone hydrochloride)
Intervention Description
Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
Primary Outcome Measure Information:
Title
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
Drug Liking: Peak Effect (Emax)
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
High: Area Under Effect Curve (AUE) From 0-2 Hours
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
High: Peak Effect (Emax)
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Secondary Outcome Measure Information:
Title
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Drug Liking: Time to Maximum (Peak) Effect (TEmax)
Description
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
High: Area Under Effect Curve (AUE) From 0-1 Hour
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
High: Area Under Effect Curve (AUE) From 0-4 Hours
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
High: Area Under Effect Curve (AUE) From 0-8 Hours
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
High: Area Under Effect Curve (AUE) From 0-12 Hours
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
High: Area Under Effect Curve (AUE) From 0-24 Hours
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
High: Time to Maximum (Peak) Effect (TEmax)
Description
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Good Effects: Peak Effect (Emax)
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Good Effects: Time to Maximum (Peak) Effect (TEmax)
Description
Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Any Effects: Peak Effect (Emax)
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Any Effects: Time to Maximum (Peak) Effect (TEmax)
Description
Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Bad Effects: Peak Effect (Emax)
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Bad Effects: Time to Maximum (Peak) Effect (TEmax)
Description
Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
Pre-dose, 0.5 and 1 hrs post-dose
Title
Nausea: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Title
Nausea: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Nausea: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Nausea: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Nausea: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Nausea: Peak Effect (Emax)
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Nausea: Time to Maximum (Peak) Effect (TEmax)
Description
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Feel Sick: Peak Effect (Emax)
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Feel Sick: Time to Maximum (Peak) Effect (TEmax)
Description
Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Sleepy: Peak Effect (Emax)
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Sleepy: Time to Maximum (Peak) Effect (TEmax)
Description
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
0.5 and 1 hrs post-dose
Title
Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
0.5, 1, 1.5 and 2 hrs post-dose
Title
Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Dizzy: Peak Effect (Emax)
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Dizzy: Time to Maximum (Peak) Effect (TEmax)
Description
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Overall Drug Liking Effect at 24 Hours
Description
Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").
Time Frame
24 hrs post dose
Title
Take Drug Again Effect at 24 Hours
Description
Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
Time Frame
24 hrs post dose
Title
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).
Time Frame
Pre-dose, 0.5 and 1 hrs post-dose
Title
Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).
Time Frame
Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Title
Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Pupillometry: Peak Effect (Emax)
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Pupillometry: Time to Maximum (Peak) Effect (TEmax)
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Maximum Observed Plasma Concentration (Cmax) of Morphine
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine
Description
AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
Time Frame
Pre-dose, 0.5 and 1 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine
Description
AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
Time Frame
Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine
Description
AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine
Description
AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine
Description
AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine
Description
AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine
Description
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Maximum Observed Plasma Concentration (Cmax) of Naltrexone
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone
Description
AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
Time Frame
Pre-dose, 0.5 and 1 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone
Description
AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
Time Frame
Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone
Description
AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone
Description
AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone
Description
AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone
Description
AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone
Description
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)
Description
AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).
Time Frame
Pre-dose, 0.5 and 1 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)
Description
AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).
Time Frame
Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)
Description
AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)
Description
AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)
Description
AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)
Description
AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)
Description
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is a recreational opioid user who is NOT physically dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, and the Naloxone Challenge. A recreational opioid user is defined as recreationally abusing opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to Visit 1.
Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
Has a history or current diagnosis of substance dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
Has participated in, is currently participating in, or is seeking treatment for substance- and/or alcohol-related disorders (excluding nicotine and caffeine).
History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.
Has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus).
Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23745947
Citation
Setnik B, Sommerville K, Goli V, Han L, Webster L. Assessment of pharmacodynamic effects following oral administration of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules compared with crushed morphine sulfate controlled-release tablets and placebo in nondependent recreational opioid users. Pain Med. 2013 Aug;14(8):1173-86. doi: 10.1111/pme.12148. Epub 2013 Jun 7.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ALO-01-10-4005&StudyName=Abuse%20Potential%20of%20Orally%20Administered%20Crushed%20Embeda%20Compared%20to%20Crushed%20Controlled-Release%20Morphine%20and%20Placebo%20in%20Non-Dependent%20Recre
Description
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Learn more about this trial
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
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