Abuse Liability of Controlled-Release Oxycodone Formulations
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Apo-Oxycodone CR® a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR® |
Drug: Apo-Oxycodone CR®
a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®
Other Names:
|
| Active Comparator: OxyNEO® a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO® |
Drug: OxyNEO®
a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®
Other Names:
|
| Placebo Comparator: Placebo a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products |
Drug: Placebo
a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline on Visual Analogue Scale for "Drug Liking" Over 8 Hours After Drug Administration [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Change from Baseline on Visual Analogue Scale for "Drug High" Over 8 Hours After Drug Administration [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Secondary Outcome Measures
- Pupil Diameter [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Cmax [Baseline to 6 hours post-administration]
Plasma oxycodone concentration
- Profile of Mood States (POMS) [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Psychomotor Performance [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Digit Symbol Substitution Test (DSST)
- Visual Analogue Scale for "Any Drug Effects" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Visual Analogue Scale for "Good Effects" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Visual Analogue Scale for "Bad Effects" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Visual Analogue Scale for "Feel Sick" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Visual Analogue Scale for "Nausea" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Visual Analogue Scale for "Sleepy" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Visual Analogue Scale for "Dizzy" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Sedation [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Addiction Research Center Inventory (ARCI)
- Euphoria [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Addiction Research Center Inventory (ARCI)
- Dysphoric Changes [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Addiction Research Center Inventory (ARCI)
- Psychotomimetic Changes [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Addiction Research Center Inventory (ARCI)
- Somatic Disturbances [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Addiction Research Center Inventory (ARCI)
- Sensory Disturbances [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Addiction Research Center Inventory (ARCI)
- Tmax [Baseline to 6 hours post drug administration]
Plasma oxycodone concentrations
- Visual Analogue Scale for "Take Drug Again" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
- Likert Scale for "Sedation" [Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Addiction and Mental Health | Toronto | Ontario | Canada | M5S 2S1 |
Sponsors and Collaborators
- Centre for Addiction and Mental Health
- University of Toronto
Investigators
- Principal Investigator: Beth Sproule, PharmD, Centre for Addiction and Mental Health
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 043-2013