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

NCT01449565 Phase 2 COMPLETED

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.

Details

Lead sponsor	San Francisco Department of Public Health
Phase	Phase 2
Status	COMPLETED
Enrolment	100
Start date	2012-09
Completion	2016-03

Conditions

• Amphetamine-Related Disorders

Interventions

• Naltrexone
• Placebo

Primary outcomes

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

Countries

United States