NCT01882361

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Opiate Dependence
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	injectable naltrexone	Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.
DRUG	placebo comparator	this placebo has no specific pharmacological activity

Timeline

• Start date: 2013-06-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2013-06-20
• Last updated: 2020-11-06

Locations

1 site across 1 country: Russia