Back to resultsA Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
Primary Purpose
Pain, Nausea, Vomiting
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CL-108
M366
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Pain focused on measuring Pain, Nausea, Vomiting
Eligibility Criteria
Inclusion Criteria:
- BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
- Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
- Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year
Exclusion Criteria:
- Drug or alcohol dependence within the last 12 months (except nicotine)
- Subjects who had ever been in treatment for substance use disorders (except smoking cessation
- History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
- History or presence of hypotension, judged to be clinically significant based on investigator judgement
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Treatment A:CL-108 22.5mg/975mg/37.5mg
Treatment B:CL-108 37.5mg/1625mg/62.5mg
Treatment C:M366 22.5mg/975mg
Treatment D: M366 37.5mg/1625mg
Treatment E: Placebo
Arm Description
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
M366 22.5 mg/975 mg tablet by mouth
M366 37.5 mg/1625 mg tablet by mouth
Placebo 0 mg tablet by mouth
Outcomes
Primary Outcome Measures
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.
Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.
Emax of Drug Liking VAS in Treatment Phase
Drug liking VAS is the measure of balance of effects that 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 (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 is the largest effect score between 0.5 to 24 hours post-dose.
Secondary Outcome Measures
Number of Adverse Events in Dose Selection Phase
AE=Adverse Event. SAE=Serious adverse event. TEAE=Treatment-emergent adverse event.
Balance of Effects: Emin of Drug Liking VAS in Treatment Phase
Drug liking VAS is the measure of balance of effects that 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 (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). Emin is the smallest effect score between 0.5 to 8 hours post-dose.
Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase
Overall drug liking VAS is the measure of balance of effects that 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 bipolar 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'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase
Take drug again VAS is the measure of balance of effects. It 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 bipolar VAS with score ranging from 0 mm to 100 mm (0 mm = 'definitely not', 50 mm = 'do not care', and 100 mm = 'definitely so'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Positive Effects: Emax of High VAS in Treatment Phase
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score between 0 to 8 hours.
Positive Effects: TA_AUE of High VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Positive Effects: Emax of Good Effects VAS in Treatment Phase
Good drug effects VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Negative Effects: Emax of Bad Effects VAS in Treatment Phase
Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hrs.
Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. Emin is the smallest effect score between 0 to 8 hours post-dose.
Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using trapezoidal rule.
Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance.
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance. CRT also measures error scores and response accuracy. Any Errors is a combination of incorrect location errors, inaccurate response errors, no response errors, and premature errors.
Pupillometry: Maximum Pupil Constriction (MPC)
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. Pupil diameter was measured using electronic pupillometer. Measurements were collected under mesopic lighting conditions. For each subject, every effort was made to use the same eye for all assessments throughout the study. MPC is calculated as smallest observed pupil diameter - baseline pupil diameter.
Pupillometry: TA_AUE of MPC in Treatment Phase
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Full Information
NCT ID
NCT02712554
First Posted
March 15, 2016
Last Updated
October 11, 2019
Sponsor
Charleston Laboratories, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02712554
Brief Title
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
Official Title
A Randomized, Double-Blind, Placebo and Active-Controlled, Crossover Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charleston Laboratories, Inc
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.
Detailed Description
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users; to assess the cognitive and behavioral effects of CL-108 tablets following oral administration relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users; and to assess the safety of orally administered CL-108 tablets relative to hydrocodone/APAP tablets and placebo in non-dependent, recreational opioid users.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Nausea, Vomiting
Keywords
Pain, Nausea, Vomiting
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A:CL-108 22.5mg/975mg/37.5mg
Arm Type
Experimental
Arm Description
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Arm Title
Treatment B:CL-108 37.5mg/1625mg/62.5mg
Arm Type
Experimental
Arm Description
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Arm Title
Treatment C:M366 22.5mg/975mg
Arm Type
Active Comparator
Arm Description
M366 22.5 mg/975 mg tablet by mouth
Arm Title
Treatment D: M366 37.5mg/1625mg
Arm Type
Active Comparator
Arm Description
M366 37.5 mg/1625 mg tablet by mouth
Arm Title
Treatment E: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 0 mg tablet by mouth
Intervention Type
Drug
Intervention Name(s)
CL-108
Other Intervention Name(s)
Low-dose CL-108 and High-dose CL-108
Intervention Description
7.5 mg/325 mg/12.5 mg tablet
Intervention Type
Drug
Intervention Name(s)
M366
Other Intervention Name(s)
Low-dose M366 and High-dose M366
Intervention Description
7.5 mg/325 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0 mg tablet
Primary Outcome Measure Information:
Title
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
Description
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
Title
Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase
Description
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
Title
Emax of Drug Liking VAS in Treatment Phase
Description
Drug liking VAS is the measure of balance of effects that 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 (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 is the largest effect score between 0.5 to 24 hours post-dose.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hours
Secondary Outcome Measure Information:
Title
Number of Adverse Events in Dose Selection Phase
Description
AE=Adverse Event. SAE=Serious adverse event. TEAE=Treatment-emergent adverse event.
Time Frame
Up to visit 3 (Follow up)
Title
Balance of Effects: Emin of Drug Liking VAS in Treatment Phase
Description
Drug liking VAS is the measure of balance of effects that 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 (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). Emin is the smallest effect score between 0.5 to 8 hours post-dose.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase
Description
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase
Description
Overall drug liking VAS is the measure of balance of effects that 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 bipolar 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'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase
Description
Take drug again VAS is the measure of balance of effects. It 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 bipolar VAS with score ranging from 0 mm to 100 mm (0 mm = 'definitely not', 50 mm = 'do not care', and 100 mm = 'definitely so'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Positive Effects: Emax of High VAS in Treatment Phase
Description
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score between 0 to 8 hours.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Title
Positive Effects: TA_AUE of High VAS in Treatment Phase
Description
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Title
Positive Effects: Emax of Good Effects VAS in Treatment Phase
Description
Good drug effects VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase
Description
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Negative Effects: Emax of Bad Effects VAS in Treatment Phase
Description
Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hrs.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase
Description
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase
Description
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. Emin is the smallest effect score between 0 to 8 hours post-dose.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Title
Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase
Description
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using trapezoidal rule.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Title
Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase
Description
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase
Description
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Time Frame
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours
Title
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
Description
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance.
Time Frame
0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
Title
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
Description
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance. CRT also measures error scores and response accuracy. Any Errors is a combination of incorrect location errors, inaccurate response errors, no response errors, and premature errors.
Time Frame
0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)
Title
Pupillometry: Maximum Pupil Constriction (MPC)
Description
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. Pupil diameter was measured using electronic pupillometer. Measurements were collected under mesopic lighting conditions. For each subject, every effort was made to use the same eye for all assessments throughout the study. MPC is calculated as smallest observed pupil diameter - baseline pupil diameter.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)
Title
Pupillometry: TA_AUE of MPC in Treatment Phase
Description
TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Time Frame
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (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:
BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year
Exclusion Criteria:
Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard P Schachtel, M.D
Organizational Affiliation
Charleston Laboratories
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
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