Will Having Alcohol Treatment Improve Functioning?
Condition: HIV; Alcoholism
MeSH terms: Alcoholism
Intervention: Naltrexone, 50mg, once per day for 4 months; Sugar pill, 50mg, once per day for 4 months
Intervention description: 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: women; HIV; alcohol; medication; adherence; acceptability

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hazardous drinking: defined by the NIAAA as either of the following:

               1. binge drinking (4 or more drinks per occasion at least twice monthly), (NIAAA
                  2005) - OR

               2. 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 Criteria:

          -  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