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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men

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 Summary: 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).
Sponsor: San Francisco Department of Public Health

Current Primary Outcome: urine meth positivity [ Time Frame: 12 weeks ]

proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • reduction in sexual risk behavior [ Time Frame: 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 [ Time Frame: 12 weeks ]
    acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm
  • rates of adverse events [ Time Frame: 12 weeks ]
    rates of adverse events will be compared by study arm


Original Secondary Outcome:

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


Information By: San Francisco Department of Public Health

Dates:
Date Received: October 4, 2011
Date Started: September 2012
Date Completion:
Last Updated: April 11, 2016
Last Verified: April 2016