Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
Condition: Heavy Drinking; HIV; Alcohol Dependence
MeSH terms: Alcoholism; Alcoholic Intoxication
Intervention: Topiramate; Medical Management; Placebo
Intervention description: Max therapeutic dose of 150mg/day; Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week.; Placebo
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Heavy drinking (HD) is a risk factor for HIV transmission and is more common in HIV+
      individuals than in the general population. HD adversely affects health directly and reduces
      adherence to antiretroviral therapies (ARTs), in part due to alcohol-induced cognitive
      impairment. Reduced drinking improves cognitive performance and adherence to ARTs.
      Medications approved in the United States to treat alcohol dependence have a small effect
      size. However, topiramate, FDA-approved as an anticonvulsant and a prophylaxis for migraine,
      has a greater effect size in reducing drinking and promoting abstinence in alcohol dependent
      individuals. To date, there are no studies of the effects of topiramate in HIV+ heavy
      drinkers. The investigators propose to conduct a randomized, parallel-groups,
      placebo-controlled, 11-week trial of topiramate in 40 HIV+ heavy drinkers who want to reduce
      or stop their drinking. There are three primary hypotheses for this feasibility and
      proof-of-concept study. First, the investigators hypothesize that topiramate-treated patients
      will decrease the frequency of their HD more than placebo-treated patients. Second, based on
      scores from computerized neurocognitive assessments, the investigators hypothesize that
      topiramate and placebo groups will show similar performance on a battery of cognitive tests.
      Third, based on self-reported medication adherence, the investigators hypothesize that
      adherence to ARTs will be greater in the topiramate group than in the placebo group. These
      findings will provide preliminary data to support a more definitive trial of topiramate for
      the treatment of HD in HIV+ heavy drinkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seropositive for HIV

          -  Age 18-70

          -  Report average of at least twice weekly heavy drinking

          -  Willing to reduce drinking to non-hazardous levels

          -  Verbal Intelligence Quotient (Verbal IQ) of 80 or higher

          -  Willing to provide signed informed consent

          -  Willing to nominate an individual to help locate the participant's whereabouts for
             follow-up

          -  If female: non-lactating and practicing a reliable method of birth control

        Exclusion Criteria:

          -  Current clinically significant and/or uncontrolled physical disease (e.g.,
             pancreatitis, diabetes)

          -  History of nephrolithiasis

          -  Severe psychiatric illness (i.e., psychosis or mania)

          -  Current diagnosis of drug abuse or dependence (other than nicotine abuse/dependence
             and cannabis abuse)

          -  Current diagnosis of alcohol dependence (AD) too severe for participation in a trial
             in which the goal is reduced drinking

          -  Gross cognitive impairment

          -  Glaucoma

          -  Serious/confounding neurological disease (e.g, stroke, seizure)

          -  Pregnancy