CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 236 enrolled
Drug / intervention
Low-Dose Topiramate +2 moredrug
Likely dose
Low-Dose Topiramate 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01182766
NCT01182766Phase 3Completed
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High and Low Dose Topiramate for the Treatment of Alcohol-Dependent Smokers

University of Virginia·interventional·Posted Aug 17, 2010·Updated Oct 31, 2025

In Brief

A Phase 3 clinical trial evaluating Low-Dose Topiramate, Placebo, and 1 other intervention for Alcohol Dependence and Nicotine Dependence. Completed, enrolled 236 participants across 4 sites.

Detailed Summary

This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence, Nicotine Dependence
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA), M.D. Anderson Cancer Center, University of California, San Diego

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2010
Enrollment StartNov 1, 2011
Primary CompletionOct 6, 2017
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 15.9 years ago

Interventions

Low-Dose Topiramatedrug

Low-dose topiramate (up to 125 mg/day) with brief behavioral enhancement therapy

Placebodrug

Placebo with brief behavioral enhancement therapy

High-Dose Topiramatedrug

High-dose topiramate (up to 250 mg/day) with brief behavioral enhancement therapy