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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00802412 |
Purpose
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence Alcohol Dependence |
Drug: Topiramate Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men |
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Drug: Topiramate
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).
Other Name: Topamax
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Placebo Comparator: 2
90 participants, will receive matching placebo
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Drug: Placebo
Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will be included if they:
Exclusion Criteria:
Subjects will be excluded if they:
Contacts and Locations
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00802412 History of Changes |
| Other Study ID Numbers: | NEUA-003-08S |
| Study First Received: | December 3, 2008 |
| Last Updated: | January 17, 2012 |
| Health Authority: | United States: Federal Government |
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tobacco use disorders alcoholism |
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Alcoholism Tobacco Use Disorder Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Topiramate Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |