Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men
Overview
- Phase
- Phase 2
- Intervention
- Naltrexone
- Conditions
- Amphetamine-Related Disorders
- Sponsor
- San Francisco Department of Public Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- urine meth positivity
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in treating alcohol dependence and prevention of relapse to opioid dependence. It has shown promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work to determine whether monthly intramuscular injections of naltrexone will reduce methamphetamine (meth) use among actively using, meth-dependent men who have sex with men (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus placebo. The investigators will focus on MSM because of the disproportionate and intertwining epidemics of meth use and HIV in this population.
Detailed Description
The investigators will enroll 100 sexually active, meth-dependent MSM who will be randomized 1:1 to receive monthly injections of extended-release naltrexone (n=50) or placebo (n=50) for 12 weeks at weeks 0, 4, and 8. Study participants will be seen weekly at our site at the HIV Prevention Section of the San Francisco Department of Public Health, where they will provide urine for drug testing and participate in substance use counseling. All participants will receive HIV risk-reduction counseling. Behavior will be assessed using standardized measures via audio computer-assisted self-interview (ACASI).
Investigators
Phillip Coffin, MD, MIA
Director, Substance Use Research Unit
San Francisco Department of Public Health
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Naltrexone
Intervention: Naltrexone
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
urine meth positivity
Time Frame: 12 weeks
proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12
Secondary Outcomes
- rates of adverse events(12 weeks)
- reduction in sexual risk behavior(12 weeks)
- percentage of total expected injections administered(12 weeks)