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NCT01625091 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial to Reduce Drinking in Women With HIV
A Phase 3 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
NCT01625091: Completed Phase 3 study, sponsored by University of Florida.
NCT01625091 is a Phase 3 study that has completed, run by University of Florida. The registered enrollment target is 194 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625091, a Phase 3 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate whether an intervention that involves the medication naltrexone, will reduce drinking and improve health outcomes in women with HIV infection and hazardous drinking. Our central hypotheses are that, compared to women who receive placebo (sugar pill containing no medicine), women who receive naltrexone will have decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease progression, and reduced sexual risk behavior. The study design will involve 240 HIV-infected women with hazardous drinking, who will be recruited from HIV clinics, neighborhoods and referrals in Miami, Florida. Eligible women will receive either a daily pill containing naltrexone (50mg) or an identical-appearing placebo for four months. All participants will receive encouragement and feedback related to their drinking regardless of medication assignment. The study participants will be assessed at two, four and seven months after enrollment. The proposed work is innovative because pharmacologic treatment for alcohol has not been evaluated in HIV-infected women. If our hypotheses are confirmed, the study findings would transform the approach to hazardous drinking within clinics serving HIV-infected women.
Primary Outcome
The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and \<4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .
Interventions
- DRUG Placebo
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT01625091 record still lists
NCT01625091 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01625091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625091 about?
NCT01625091 is a clinical study titled "Clinical Trial to Reduce Drinking in Women With HIV". The primary objective of this study is to evaluate whether an intervention that involves the medication naltrexone, will reduce drinking and improve health outcomes in women with HIV infection and hazardous drinking. Our central hypotheses are that, compared to women who receive placebo (sugar pill ...
What is the current status of trial NCT01625091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2012-12. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01625091?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01625091?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625091's enrollment target sits among peer trials
194 1395th of 2000 higher than 604 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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