Conditions: Nicotine Dependence Alcohol Dependence
Keywords: tobacco use disorders alcoholism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 132
Healthy volunteers: no

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

Detailed description:
This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. Another aim of the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). Following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.

Arms:
arm 1: The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group. arm 2: 90 participants, will receive matching placebo

Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: 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). intervention 2: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Protocol document: