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

• Status: Completed
• Trial end date: 2013-08-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Collaborators: INC Research; Syneos Health
• Treatments: Analgesics, Opioid; Naltrexone; Oxycodone

Criteria

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.