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NCT01723384 · ClinicalTrials.gov registry record · Phase 2
Intermittent Naltrexone Among Polysubstance Users
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01723384: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01723384 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01723384, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is inexpensive and has few toxicities but the standard daily regimen for naltrexone is problematic as patients forget to take the medication. Given the challenges in daily dosing, alternate regimen schedules have been proposed to increase efficacy and expand the population that may benefit from this pharmacologic agent. One approach is intermittent targeted administration of naltrexone, whereby individuals take the medication as-needed in anticipation of substance use or during periods of craving. Administration of naltrexone prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone has shown efficacy in reducing heavy alcohol use. However, there have been no studies assessing intermittent targeted dosing of naltrexone among methamphetamine-using and binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those who abuse more than one substance are urgently needed. The aims of this study are to determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among non-dependent methamphetamine-using and binge-drinking MSM.
Primary Outcome
Proportion of persons retained by study arm.
Interventions
- DRUG Placebo
- DRUG Intermittent Oral Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01723384 record still lists
NCT01723384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01723384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01723384 about?
NCT01723384 is a clinical study titled "Intermittent Naltrexone Among Polysubstance Users". Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is inexpensive and has few toxi...
What is the current status of trial NCT01723384?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2013-05. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01723384?
The interventions under investigation include: Placebo (DRUG), Intermittent Oral Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01723384?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01723384's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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