Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

Human Immunodeficiency Virus Clinical Trial

Official title: Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

Status Completed

Clinical Trial Summary

To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.

Clinical Trial Description

1.2.1 Primary and Secondary Outcome Measures

Primary outcomes are:

1) Opiate positive urine tests; 2) HIV injecting risk.

Secondary outcomes are:

1) Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.

Hypotheses are that:

1. Primary outcomes will significantly favor the 48-week Vivitrol condition;

2. Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Opiate Dependence
• Opioid-Related Disorders

• NCT number: NCT01882361
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2013
• Completion date: July 31, 2020