Abuse Liability of Controlled-Release Oxycodone Formulations

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.

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