Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
This study is not yet open for participant recruitment.
Verified January 2013 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Information provided by (Responsible Party):
Henry Kranzler, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01764685
First received: January 4, 2013
Last updated: January 7, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Topiramate
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764685
Contacts
| Contact: Henry R. Kranzler, M.D. | 215-222-3200 ext 137 | kranzler@mail.med.upenn.edu |
| Contact: Timothy S. Pond, M.P.H. | 215-222-3200 ext 241 | timpond@mail.med.upenn.edu |
Locations
| United States, Pennsylvania | |
| University of Pennsylvania Treatment Research Center | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Timothy S. Pond, M.P.H. 215-222-3200 ext 241 timpond@mail.med.upenn.edu | |
| Contact: Kara R. Douglas, M.S. 215-222-3200 ext 111 karadoug@mail.med.upenn.edu | |
| Principal Investigator: Henry R. Kranzler, M.D. | |
| Sub-Investigator: Kyle M. Kampman, M.D. | |
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: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
HIV Seropositivity HIV Infections Alcoholic Intoxication Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Topiramate Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 22, 2013