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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01825447

Run by

Pfizer

People needed

89

Starts

2013-07-01

Expected to finish

2013-09-01

Last updated by the study team

2013-10-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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