CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 132 enrolled
Drug / intervention
Topiramate +1 moredrug
Likely dose
Topiramate 200 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/NCT00802412
NCT00802412Phase 2Completed
CompareCT.gov

Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

VA Office of Research and Development·interventional·Posted Dec 4, 2008·Updated Jan 31, 2017

In Brief

A Phase 2 clinical trial evaluating Topiramate and Placebo for Nicotine Dependence and Alcohol Dependence. Completed, enrolled 132 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence, Alcohol Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 4, 2008
Enrollment StartJan 1, 2009
Primary CompletionNov 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.6 years ago

Interventions

Topiramatedrug

Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).

Placebodrug

Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.