CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Naltrexone, 50mg, once per day for 4 months +1 moredrug
Likely dose
Naltrexone, 50mg, once per day for 4 monthsfrom 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/NCT01245647
NCT01245647Phase 2Completed

Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial

University of Florida·interventional·Posted Nov 22, 2010·Updated May 7, 2018

In Brief

A Phase 2 clinical trial evaluating Naltrexone, 50mg, once per day for 4 months and Sugar pill, 50mg, once per day for 4 months for HIV and Alcoholism. Completed, enrolled 19 participants across 3 sites.

Detailed Summary

The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Naltrexone has not been used widely among people who are engaged in less severe drinking and in primary health care settings. Therefore, the investigators would like to determine whether it is helpful among women who sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce their drinking which in turn will improve their medication adherence, improve their health and quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Alcoholism
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 22, 2010
Enrollment StartNov 1, 2010
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.6 years ago

Interventions

Naltrexone, 50mg, once per day for 4 monthsdrug

Naltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months.

Sugar pill, 50mg, once per day for 4 monthsother

Placebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months.