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NCT01449565 · ClinicalTrials.gov registry record · Phase 2
Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)
A Phase 2 study of Amphetamine-Related Disorders, sponsored by San Francisco Department of Public Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01449565: Completed Phase 2 study of Amphetamine-Related Disorders, sponsored by San Francisco Department of Public Health.
NCT01449565 is a Phase 2 study of Amphetamine-Related Disorders that has completed, run by San Francisco Department of Public Health. The registered enrollment target is 100 participants, above the 72-participant average among 5 other Amphetamine-Related Disorders trials with a reported enrollment target (39% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01449565, a Phase 2 study of Amphetamine-Related Disorders, has completed, sponsored by San Francisco Department of Public Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naltrexone
Study Locations (1)
California
- Substance Use Research Unit - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01449565 record still lists
NCT01449565 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 72-participant average among 5 other Amphetamine-Related Disorders trials with a reported enrollment target (39% higher).
The record links to 1 condition, with Amphetamine-Related Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01449565 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01449565 about?
NCT01449565 is a clinical study titled "Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)". 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 heter...
What is the current status of trial NCT01449565?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2012-09. Estimated completion is 2016-03.
What conditions does trial NCT01449565 study?
This clinical trial studies the following conditions: Amphetamine-Related Disorders.
What interventions are being tested in trial NCT01449565?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01449565?
This trial is sponsored by San Francisco Department of Public Health, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01449565 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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