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Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

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ClinicalTrials.gov Identifier: NCT01764685
Recruitment Status : Terminated (We terminated the study due to problems recruiting alcoholic subjects with HIV.)
First Posted : January 9, 2013
Results First Posted : February 17, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Henry Kranzler, University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Heavy Drinking HIV Alcohol Dependence Drug: Topiramate Behavioral: Medical Management Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: Topiramate + Medical Management
Topiramate titrated up to 150 mg/day over 5 weeks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit
Drug: Topiramate
Max therapeutic dose of 150mg/day
Other Name: Topamax

Behavioral: Medical Management
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 Comparator: Placebo Pill + Medical Management
Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit
Behavioral: Medical Management
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.

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Number of Heavy Drinking Days Per Week by Medication Group [ Time Frame: 11-week study period ]
    Total number of heavy drinking days (>4 drinks for men; >3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764685


Locations
United States, Pennsylvania
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Henry R. Kranzler, M.D. University of Pennsylvania
Study Director: Kara R. Douglas, M.S. University of Pennsylvania
Study Chair: Timothy S. Pond, M.P.H. University of Pennsylvania

Additional Information:
Responsible Party: Henry Kranzler, Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01764685     History of Changes
Other Study ID Numbers: 816082
First Posted: January 9, 2013    Key Record Dates
Results First Posted: February 17, 2016
Last Update Posted: March 15, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Alcoholism
Alcoholic Intoxication
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents