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Will Having Alcohol Treatment Improve Functioning?

NCT01245647 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-05-07

Study results available
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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.

Conditions

  • HIV
  • Alcoholism

Interventions

DRUG

Naltrexone, 50mg, once per 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.

OTHER

Sugar pill, 50mg, once per 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.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Robert L Cook, MD, MPH · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245647 on ClinicalTrials.gov