Clinical Trial to Reduce Drinking in Women With HIV
Public ClinicalTrials.gov record NCT01625091. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pharmacotherapy for Alcohol Consumption in HIV Infected Women: Randomized Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01625091
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 194 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2012
- Primary completion
- Jun 30, 2016
- Completion
- Jun 30, 2016
- Last update posted
- Jul 9, 2018
2012 – 2016
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami | Coral Gables | Florida | 33124 | — |
| Florida International University | Miami | Florida | 33199 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01625091, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 9, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01625091 live on ClinicalTrials.gov.