Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

NCT01764685 | Terminated Phase 2 Results

• 1 other identifier: 816082
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Drinking; HIV; Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• Number of Heavy Drinking Days Per Week by Medication Group

  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.

  11-week study period

Study Arms (2)

Topiramate + Medical Management

EXPERIMENTAL

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; Behavioral: Medical Management

Placebo Pill + Medical Management

PLACEBO COMPARATOR

Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit

Behavioral: Medical Management; Drug: Placebo

Interventions

Topiramate DRUG

Max therapeutic dose of 150mg/day

Also known as: Topamax

Topiramate + Medical Management

Medical Management BEHAVIORAL

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 Pill + Medical Management; Topiramate + Medical Management

Placebo DRUG

Placebo

Placebo Pill + Medical Management

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Clinical research programs in the Department of Psychiatry at the Perelman School of Medicine/University of Pennsylvania

MeSH Terms

Conditions

Alcoholism

Interventions

Topiramate; Practice Management, Medical

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Limitations and Caveats

We closed our enrollment before meeting recruitment goals, due to difficulties with recruitment. We didn't analyze our data, due to a sample size of 4, that were all randomized to placebo group and only 3 of the 4 completed the study procedures.

Results Point of Contact

• Title: Henry R. Kranzler, M.D.
• Organization: University of Pennsylvania Perelman School of Medicine

kranzler@mail.med.upenn.edu

215-386-6662

Study Officials

• Henry R. Kranzler, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Kara R. Douglas, M.S.

  University of Pennsylvania

  STUDY DIRECTOR

• Timothy S. Pond, M.P.H.

  University of Pennsylvania

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 15, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-02

Locations

US (1)