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

NCT01449565 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-04-13

No results posted yet for this study

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.

Conditions

  • Amphetamine-Related Disorders

Interventions

DRUG

Naltrexone

3 monthly intramuscular injections of naltrexone 380 mg (extended release)

DRUG

Placebo

3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)

Sponsors & Collaborators

  • Alkermes, Inc.

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • San Francisco Department of Public Health

    lead OTHER_GOV

Principal Investigators

  • Steven L. Batki, MD · Substance Abuse Programs, San Francisco VA Medical Center

  • Phillip Coffin, MD, MIA · Substance Use Research Unit, San Francisco Department of Public Health

  • Emily Behar, MS · San Francisco Department of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01449565 on ClinicalTrials.gov