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Abuse Liability of Controlled-Release Oxycodone Formulations

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Apo-Oxycodone CR®
OxyNEO®
Placebo
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Substance-Related Disorders focused on measuring Substance-Related Disorders, Prescription Drug Misuse, Analgesics, Opioid, Oxycodone, Randomized Controlled Trial, Cross-Over Studies, Placebo, Healthy Volunteers

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and female subjects 18 to 50 years of age
  • Willing and capable to give written informed consent
  • Subjects must have used opioids recreationally to achieve a "high" on at least five occasions in the 12 months before screening and at least once in the 90 days before screening according to self-report
  • Females of childbearing potential have to use a medically acceptable form of birth control and have a negative pregnancy test
  • Pass medical assessment, which includes physical examination, assessment of medical history, vital signs, blood work, and urine toxicology screen
  • Willing to abstain from alcohol 12 hours before and during the study days

Exclusion Criteria:

  • Current or past Axis I psychiatric illness (including current drug dependence or past opioid dependence, except nicotine dependence)
  • Current hepatic disease or renal failure
  • Pregnancy or lactation in women
  • Current medication that is known to interact with opioids
  • Known contraindications or hypersensitivity to opioids
  • Current opioid therapy
  • Chronic pain disorder requiring regular medication

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Apo-Oxycodone CR®

OxyNEO®

Placebo

Arm Description

a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®

a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®

a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products

Outcomes

Primary Outcome Measures

Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration
Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration

Secondary Outcome Measures

Pupil Diameter
Cmax
Plasma oxycodone concentration
Profile of Mood States (POMS)
Psychomotor Performance
Digit Symbol Substitution Test (DSST)
Visual Analogue Scale for "Any Drug Effects"
Visual Analogue Scale for "Good Effects"
Visual Analogue Scale for "Bad Effects"
Visual Analogue Scale for "Feel Sick"
Visual Analogue Scale for "Nausea"
Visual Analogue Scale for "Sleepy"
Visual Analogue Scale for "Dizzy"
Sedation
Addiction Research Center Inventory (ARCI)
Euphoria
Addiction Research Center Inventory (ARCI)
Dysphoric Changes
Addiction Research Center Inventory (ARCI)
Psychotomimetic Changes
Addiction Research Center Inventory (ARCI)
Somatic Disturbances
Addiction Research Center Inventory (ARCI)
Sensory Disturbances
Addiction Research Center Inventory (ARCI)
Tmax
Plasma oxycodone concentrations
Visual Analogue Scale for "Take Drug Again"
Likert Scale for "Sedation"

Full Information

First Posted
March 24, 2014
Last Updated
January 8, 2015
Sponsor
Centre for Addiction and Mental Health
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02101840
Brief Title
Abuse Liability of Controlled-Release Oxycodone Formulations
Official Title
Abuse Liability of Controlled-Release Oxycodone Formulations
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to examine the abuse liability of a single 40mg dose of 2 controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent recreational opioid users by assessing the self-reported acute effects of the drugs and taking blood samples to measure drug concentrations. The investigators think there may be differences in how well these drugs are liked when swallowed whole due to differences in how the products are formulated.
Detailed Description
This is a single-center, single-dose, double-blind, placebo-controlled, randomized, crossover, abuse liability study conducted in healthy subjects who are non-dependent recreational opioid users. The study consists of 3 study days during which each subject will take one tablet of either 40mg OxyNEO®, 40mg Apo-Oxycodone CR®, or placebo. The participants will be assessed for both pharmacokinetic and pharmacodynamic outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Substance-Related Disorders, Prescription Drug Misuse, Analgesics, Opioid, Oxycodone, Randomized Controlled Trial, Cross-Over Studies, Placebo, Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apo-Oxycodone CR®
Arm Type
Active Comparator
Arm Description
a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®
Arm Title
OxyNEO®
Arm Type
Active Comparator
Arm Description
a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products
Intervention Type
Drug
Intervention Name(s)
Apo-Oxycodone CR®
Other Intervention Name(s)
Oxycodone
Intervention Description
a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®
Intervention Type
Drug
Intervention Name(s)
OxyNEO®
Other Intervention Name(s)
Oxycodone
Intervention Description
a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products
Primary Outcome Measure Information:
Title
Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Secondary Outcome Measure Information:
Title
Pupil Diameter
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Cmax
Description
Plasma oxycodone concentration
Time Frame
Baseline to 6 hours post-administration
Title
Profile of Mood States (POMS)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Psychomotor Performance
Description
Digit Symbol Substitution Test (DSST)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Visual Analogue Scale for "Any Drug Effects"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Visual Analogue Scale for "Good Effects"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Visual Analogue Scale for "Bad Effects"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Visual Analogue Scale for "Feel Sick"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Visual Analogue Scale for "Nausea"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Visual Analogue Scale for "Sleepy"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Visual Analogue Scale for "Dizzy"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Sedation
Description
Addiction Research Center Inventory (ARCI)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Euphoria
Description
Addiction Research Center Inventory (ARCI)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Dysphoric Changes
Description
Addiction Research Center Inventory (ARCI)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Psychotomimetic Changes
Description
Addiction Research Center Inventory (ARCI)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Somatic Disturbances
Description
Addiction Research Center Inventory (ARCI)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Sensory Disturbances
Description
Addiction Research Center Inventory (ARCI)
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Tmax
Description
Plasma oxycodone concentrations
Time Frame
Baseline to 6 hours post drug administration
Title
Visual Analogue Scale for "Take Drug Again"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration
Title
Likert Scale for "Sedation"
Time Frame
Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male and female subjects 18 to 50 years of age Willing and capable to give written informed consent Subjects must have used opioids recreationally to achieve a "high" on at least five occasions in the 12 months before screening and at least once in the 90 days before screening according to self-report Females of childbearing potential have to use a medically acceptable form of birth control and have a negative pregnancy test Pass medical assessment, which includes physical examination, assessment of medical history, vital signs, blood work, and urine toxicology screen Willing to abstain from alcohol 12 hours before and during the study days Exclusion Criteria: Current or past Axis I psychiatric illness (including current drug dependence or past opioid dependence, except nicotine dependence) Current hepatic disease or renal failure Pregnancy or lactation in women Current medication that is known to interact with opioids Known contraindications or hypersensitivity to opioids Current opioid therapy Chronic pain disorder requiring regular medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Sproule, PharmD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.camh.ca/en/research
Description
The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.

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Abuse Liability of Controlled-Release Oxycodone Formulations

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