A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-dose, 6-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules) Compared To Oxycodone Immediate Release And Placebo When Administered Orally To Nondependent,Recreational Opioid Users.

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Abuse Liability Study

Inclusion Criteria:

• Healthy subjects.
• Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit.

Exclusion Criteria:

• Diagnosis of substance and/or alcohol dependence.
• Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder.
• History of sleep apnea.
• Positive urine drug screen (UDS) for other that marijuana.
• Positive for Hepatitis B or C and HIV on Screening.