Abuse Liability of Controlled-Release Oxycodone Formulations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Abuse Liability of Controlled-Release Oxycodone Formulations

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Drug: Apo-Oxycodone CR®
* Drug: OxyNEO®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apo-Oxycodone CR®<br>a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR® | Drug: Apo-Oxycodone CR®<br>* a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®<br>* Other names: Oxycodone;|
| Active Comparator: OxyNEO®<br>a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO® | Drug: OxyNEO®<br>* a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®<br>* Other names: Oxycodone;|
| Placebo Comparator: Placebo<br>a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products | Drug: Placebo<br>* a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance-Related Disorders, Prescription Drug Misuse, Analgesics, Opioid, Oxycodone, Randomized Controlled Trial, Cross-Over Studies, Placebo, Healthy Volunteers