Abuse Liability of Controlled-Release Oxycodone Formulations

Center for Addiction and Mental Health (CAMH)

Status and phase: Completed; Phase 4

Conditions: Substance-Related Disorders

Treatments: Drug: OxyNEO®; Drug: Placebo; Drug: Apo-Oxycodone CR®

Study type: Interventional

Funder types: Other

Identifiers

NCT02101840

043-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 3 patient groups, including a placebo group

Apo-Oxycodone CR®

Active Comparator group

Description:

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

Treatment:

Drug: Apo-Oxycodone CR®

OxyNEO®

Active Comparator group

Description:

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

Treatment:

Drug: OxyNEO®

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo