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| Name | Class |
|---|---|
| University of Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apo-Oxycodone CR® | Active Comparator | a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR® |
|
| OxyNEO® | Active Comparator | a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO® |
|
| Placebo | Placebo Comparator | a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apo-Oxycodone CR® | Drug | a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Plasma oxycodone concentration | Baseline to 6 hours post-administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Sproule, PharmD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
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| Label | URL |
|---|---|
| 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. | View source |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D063487 | Prescription Drug Misuse |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000076064 | Drug Misuse |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| OxyNEO® | Drug | a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO® |
|
|
| Placebo | Drug | a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products |
|
| 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 | Digit Symbol Substitution Test (DSST) | 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 "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 | Addiction Research Center Inventory (ARCI) | Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration |
| Euphoria | Addiction Research Center Inventory (ARCI) | Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration |
| Dysphoric Changes | Addiction Research Center Inventory (ARCI) | Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration |
| Psychotomimetic Changes | Addiction Research Center Inventory (ARCI) | Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration |
| Somatic Disturbances | Addiction Research Center Inventory (ARCI) | Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration |
| Sensory Disturbances | Addiction Research Center Inventory (ARCI) | Baseline and 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hours after drug administration |
| Tmax | Plasma oxycodone concentrations | Baseline to 6 hours post drug administration |
| 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 |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |