Clinical Trial to Reduce Drinking in Women With HIV
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: Naltrexone; Placebo
Intervention description: The study involves taking the drug naltrexone for up to 4 months. This will be given in a single pill each day for 4 months.; Placebo is an inert pill that looks the same as naltrexone. The placebo will be taken once each day for up to 4 months.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; women; drinking; Naltrexone

Summary:

      The primary objective of this study is to evaluate whether an intervention that involves the
      medication naltrexone, will reduce drinking and improve health outcomes in women with HIV
      infection and hazardous drinking. Our central hypotheses are that, compared to women who
      receive placebo (sugar pill containing no medicine), women who receive naltrexone will have
      decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease
      progression, and reduced sexual risk behavior. The study design will involve 240 HIV-infected
      women with hazardous drinking, who will be recruited from HIV clinics, neighborhoods and
      referrals in Miami, Florida.

      Eligible women will receive either a daily pill containing naltrexone (50mg) or an
      identical-appearing placebo for four months. All participants will receive encouragement and
      feedback related to their drinking regardless of medication assignment. The study
      participants will be assessed at two, four and seven months after enrollment. The proposed
      work is innovative because pharmacologic treatment for alcohol has not been evaluated in
      HIV-infected women. If our hypotheses are confirmed, the study findings would transform the
      approach to hazardous drinking within clinics serving HIV-infected women.
    

Eligibility criteria:

        Inclusion Criteria: (must meet all of following):

          -  Hazardous drinking, on average, during the preceding 4 weeks. Defined as binge
             drinking (4 or more drinks per occasion at least twice monthly) and/or high total
             weekly consumption (>7 drinks per week).

          -  Age 18 or over

          -  Female

          -  HIV infection (documented by medical record blood test result or testing done for this
             study)

          -  Able to understand and comply with study procedures and to provide written consent.

        Exclusion criteria: (cannot have any of the following):

          -  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 upper normal),
             evidence of acute hepatitis, or receiving hemodialysis for renal failure

          -  Currently pregnant

          -  Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone,
             acamprosate).

          -  Currently unable to provide mailing address or reliable contact information, or has
             plans to move from area within next 7 months

          -  Unable to communicate in English or Spanish

          -  Research coordinator assessment that participant cannot comprehend the study or
             consent procedures (e.g. participant appears to be intoxicated, answers questions in a
             non-sensible manner)

          -  Has current prognosis of less than one year to live (e.g. in Hospice, has metastatic
             cancer)

          -  Currently taking antiviral treatment for hepatitis C infection (interferon or
             ribavirin)

          -  Has other unique health condition, not specifically listed, that should exclude the
             participant after discussion with Dr. Cook, Dr. Espinoza, and perhaps also the
             participant's primary HIV physician (for example an unexpected abnormal laboratory
             result turns up on the baseline screening metabolic panel).