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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 is a Phase 3 study that has completed, run by University of Florida. The registered enrollment target is 194 participants.
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.
Interventions
- DRUG Placebo
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01625091
The ClinicalTrials.gov registry entry for NCT01625091 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01625091 reports 0 study locations.
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.
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