Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)

Phase 2

Completed

• Conditions: Amphetamine-Related Disorders
• Interventions: Drug: Naltrexone; Drug: Placebo

• Registration Number: NCT01449565
• Lead Sponsor: San Francisco Department of Public Health

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).

Study Timeline

• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Study Start: 2012-09
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone	Naltrexone	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
urine meth positivity	12 weeks	proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12

Secondary Outcome Measures

Name	Time	Method
rates of adverse events	12 weeks	rates of adverse events will be compared by study arm
reduction in sexual risk behavior	12 weeks	reduction in meth-associated sexual risk behavior as measured by: numbers of male anal sex partners, serodiscordant condomless anal sex partners, serodiscordant condomless anal sex events, serodiscordant condomless receptive anal sex partners, serodiscordant condomless receptive anal sex events, serodiscordant condomless insertive anal sex partners, serodiscordant condomless insertive anal sex events, and numbers of sex partners with whom meth was used, by study arm
percentage of total expected injections administered	12 weeks	acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm

Trial Locations

Locations (1)

Substance Use Research Unit; 🇺🇸 San Francisco, California, United States