Alcohol Drinking Clinical Trial
Official title:
Topiramate Treatment of Problem Drinkers
The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of up to 200mg/day, topiramate will be well tolerated in this patient population and that, compared to placebo treatment, topiramate will result in a greater reduction in the frequency of both drinking days and heavy drinking days.
It is estimated that 30% of the general population are problem drinkers (NIAAA 2007). Despite
its high prevalence, problem drinkers are understudied, particularly with respect to
medications that may help them to reduce their drinking to safe levels. The study will extend
to this patient population findings from a trial of topiramate, which showed the drug to be
well tolerated and efficacious in moderately-severe alcohol-dependent patients (Johnson et
al. 2003).
This is a 13-week, double-blind, placebo-controlled study of topiramate (12 weeks during
which the dosage of study medication is gradually increased up to 200 mg orally and then
maintained, and 1 week of medication taper) and medical management counseling to reduce
drinking among problem drinkers (i.e., heavy drinkers without evidence of physical dependence
on alcohol) who want to reduce their drinking.
Participants attend weekly study visits for the first 5 weeks and then bi-weekly visits for
the last 8 weeks of the study, and are randomly assigned to receive topiramate or placebo on
a daily basis. In addition to study visits, participants report daily moods, drinking, and
medication usage through an Interactive Voice Response (IVR) system they call each night.
In-person follow-up evaluations are conducted at 3 and 6 months post-treatment to provide a
measure of the durability of treatment effects. This study also aims to examine the relation
between genotype and the response to topiramate treatment.
An additional aim is to conduct a substudy to examine neural cells generated from skin
fibroblast cells obtained from study participants via a skin biopsy (participation in the
substudy is completely optional). Initially, we will examine variables key to reliably
generating neurons from the cells and characterize these neurons using a variety of
laboratory measures. A longer term goal is to compare gene expression in individuals who show
a robust reduction in drinking following treatment with topiramate with those who show no
beneficial treatment effects.
A second additional aim is to explore whether the therapeutic and adverse effects of
topiramate are similar in patients on a stable regimen of an antidepressant to those not
receiving such therapy. Although exploratory, given the absence of data that directly address
this issue, we will stratify subjects by the presence or absence of current antidepressant
therapy.
Careful evaluation of the study's hypotheses will provide important information on the
efficacy and mechanism of effects of topiramate as a treatment for problem drinkers.
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