CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 194 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01625091
NCT01625091Phase 3Completed

Pharmacotherapy for Alcohol Consumption in HIV Infected Women: Randomized Trial

University of Florida·interventional·Posted Jun 21, 2012·Updated Jul 10, 2018

In Brief

A Phase 3 clinical trial evaluating Naltrexone and Placebo for HIV Infection. Completed, enrolled 194 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesUnited States

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2012
Enrollment StartDec 1, 2012
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.0 years ago

Interventions

Naltrexonedrug

The study involves taking the drug naltrexone for up to 4 months. This will be given in a single pill each day for 4 months.

Placebodrug

Placebo is an inert pill that looks the same as naltrexone. The placebo will be taken once each day for up to 4 months.