NCT01245647|CompletedPhase 2Results
Will Having Alcohol Treatment Improve Functioning?
WHAT-IF
Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial
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Sponsor study identifier
Secondary identifiers
interventional
19
1 country
3
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 19, 2010
Actual (reported)November 22, 2010
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)February 27, 2014
Actual (reported)Number of Drinks Per Week
Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.
Month 4
HIV Medication Adherence (95% or Better)
Month 4
Risky Sexual Behaviors
4 months
HIV Viral Load Suppressed
4 months
CD4 Count (Mean)
4 months
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.
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.
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.
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.
Women's Interagency HIV Study
Washington D.C., District of Columbia, 20007, United States
University of Florida Health Science Center
Jacksonville, Florida, 32209, United States
Women's Interagency HIV Study
Chicago, Illinois, 60612, United States
Sample size was very small, and 3 participants did not return for any follow-up visits; 15 completed through the Month 4 assessment, and 12 completed through Month 7. Therefore, our ability to draw conclusions based on this sample is limited.
Robert L Cook, MD, MPH
University of Florida
19 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2010
First Posted
November 22, 2010
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
May 7, 2018
Results First Posted
February 27, 2014
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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