A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.

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

Details

• Lead Sponsor: Pfizer
• Collaborator: Lifetree Clinical Research Center, Salt Lake City, Utah
• Treatments: Naltrexone; Oxycodone

Criteria

Inclusion Criteria:

• Healthy subjects

• Non-dependent, recreational opioid users

• Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Exclusion Criteria:

• Diagnosis of substance and/or alcohol dependence

• Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder

• History of sleep apnea.