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Report for Clinical Trial NCT02371889

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers

The purpose of this study is to advance the effort to develop personalized pharmacotherapy for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD. The investigators will stratify the randomization on genotype and oversample rs2832407*C homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in the four medication x genotype groups. The investigators will use daily data collection to examine changes in relevant process variables (e.g., alcohol expectancies) and their interaction with genotype and medication group as predictors of HD. The proposed study is innovative in that it will be the first prospective test of a pharmacogenetic hypothesis involving TOP; it will use daily reports to examine expectancies and how they interact with medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is either to reduce or stop drinking, which will increase the study's external validity.

NCT02371889 Alcoholism
MeSH: Alcoholism Alcoholic Intoxication

3 Interventions

Name: Topiramate

Description: Max therapeutic dose of 200mg/day

Type: Drug

Topiramate + Medical Management

Name: Medical Management

Description: Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop 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 subject 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 subject'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 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.

Type: Behavioral

Placebo Pill + Medical Management Topiramate + Medical Management

Name: Inactive Placebo

Description: In capsules indistinguishable from topiramate capsules and gradually increased to a maximum equivalent of 200 mg of topiramate/day

Type: Drug

Placebo Pill + Medical Management


Primary Outcomes

Description: The four medication by genotype groups will be compared on weekly number of Heavy Drinking Days.

Measure: Frequency of Heavy Drinking Days Per Week by Medication and Genotype Group (timeline follow back calendar).

Time: 12 weeks

Secondary Outcomes

Description: Daily Interactive Voice Response (IVR) to Alcohol Expectancies questions compared to reported daily drinking.

Measure: Frequency of positive expectancies regarding alcohols positive effects and level of confidence in resisting heavy drinking by Medication and Genotype Group (daily questionnaire).

Time: 12 weeks

Other Outcomes

Description: 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.

Measure: Severity of Adverse Effects in Study Participants (Questionnaire)

Time: 12 weeks

Description: Demonstrate neuromodulatory effects of a GABA/glutamate modulator, topiramate, on RB and alcohol cue reactivity

Measure: Conduct an optional sub-study of 100 of the randomized subjects, to examine the effects of topiramate on resting baseline (RB) cerebral blood flow and alcohol cue reactivity using functional magnetic resonance imaging (fMRI)andomized subjects.

Time: 8 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs2832407

The investigators propose to conduct a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD.

The investigators will stratify the randomization on genotype and oversample rs2832407*C homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in the four medication x genotype groups.

12. Judged by the principal investigator or his designee to be an unsuitable candidate for receipt of an investigational drug Alcoholism Alcoholism Alcoholic Intoxication This is a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of topiramate in reducing HD in 200 individuals of European descent with DSM-5 AUD.

The investigators will stratify the randomization on genotype and oversample rs2832407*C homozygotes, the most topiramate-responsive genotype, to ensure comparable numbers of subjects in the four medication x genotype groups.

The investigators will select subjects based on their genotype to ensure comparable numbers of individuals who are rs2832407*C-allele homozygotes and A-allele carriers.



HPO Nodes