Trial record 3 of 30 for:    " December 23, 2012":" January 22, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Henry Kranzler, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01764685
First received: January 4, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Heavy Drinking
HIV
Alcohol Dependence
Drug: Topiramate
Behavioral: Medical Management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Frequency of heavy drinking days per week by medication group [ Time Frame: 11-week study period ] [ Designated as safety issue: No ]
    Number of heavy drinking days (>4 drinks for men; >3 drinks for women) for each participant during the study period. Two-level hierarchical linear models will examine the main effect of Medication Group and the Medication Group x Time interaction.


Secondary Outcome Measures:
  • Frequency, type, and severity of adverse effects in study participants [ Time Frame: 11-week study period ] [ Designated as safety issue: Yes ]
    Frequency, type, and severity of adverse effects will be assessed at each study visit to determine the safety of topiramate. These outcomes will be compared for patients receiving TOP or placebo using Chi-squared analysis.

  • Composite score on neuropsychological testing [ Time Frame: 11-week study period ] [ Designated as safety issue: No ]
    Performance on CogState neuropsychological battery

  • Weekly adherence to antiretroviral medication [ Time Frame: 11-week study period ] [ Designated as safety issue: No ]
    Number of days in which prescribed medication dose was taken each week


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Henry Kranzler, Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01764685     History of Changes
Other Study ID Numbers: 816082
Study First Received: January 4, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Alcoholic Intoxication
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mental Disorders
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Substance-Related Disorders
Virus Diseases
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014