drugset / Trial / NCT01449565

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

NCT01449565

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-09
Primary completion
2015-12
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naltrexone Small molecule 380 mg Intramuscular