Status:
COMPLETED
Will Having Alcohol Treatment Improve Functioning?
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
HIV
Alcoholism
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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, whe...
Detailed Description
The primary objective of this study is to evaluate the acceptability and effectiveness of a treatment program for hazardous drinking, delivered within HIV-clinic outpatient settings, that involves ora...
Eligibility Criteria
Inclusion
- Hazardous drinking: defined by the NIAAA as either of the following:
- binge drinking (4 or more drinks per occasion at least twice monthly), (NIAAA 2005) - OR
- high quantity-frequency (\>7 or drinks per week)
- Age 18 or over
- Female
- HIV-infected documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA viral load or a second antibody test by a method other than ELISA at any time prior to study entry.
- Able to understand and comply with planned study procedures.
- Willing and able to provide informed consent.
Exclusion
- Contraindications to treatment with naltrexone: current physiologic opiate dependence; current daily prescription opioid medications; positive urine drug test for opioids; allergic to naltrexone; significantly abnormal baseline liver enzymes (AST or ALT ≥ 5 times normal); on dialysis for renal failure
- currently taking oral medications for tuberculosis.
- Currently pregnant or positive pregnancy test.
- currently breastfeeding.
- Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone, acamprosate).
- currently homeless, unable to provide mailing address, or has plans to move from area within next 7 months.
- Unable to communicate in English.
- Research coordinator assessment that participant cannot comprehend the study or consent procedures
- Has current prognosis of less than 1 year to live
- Abnormal vital signs at enrollment visit
- Currently on treatment for Hepatitis C (HCV) infection
- Prisoner status
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01245647
Start Date
November 1 2010
End Date
October 1 2012
Last Update
May 7 2018
Active Locations (3)
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1
Women's Interagency HIV Study
Washington D.C., District of Columbia, United States, 20007
2
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
3
Women's Interagency HIV Study
Chicago, Illinois, United States, 60612