Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
|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|
- 4-week continuous abstinence from smoking [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Percent relapsing to any drinking [ Time Frame: 12-week treatment phase, 36-week combined treatment and follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.
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
Placebo Comparator: Arm 2
90 participants, will receive matching placebo
Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
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.
|Contact: Elizabeth N Dinh, MA||(858) firstname.lastname@example.org|
|Contact: Robert M Anthenelli, MD||(513) 861-3100 ext email@example.com|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Robert M Anthenelli, MD 513-861-3100 ext 4914 firstname.lastname@example.org|
|Contact: Elizabeth N Dinh, MA (858) 642-1026 email@example.com|
|Principal Investigator: Robert M. Anthenelli, MD|
|Principal Investigator:||Robert M. Anthenelli, MD||VA San Diego Healthcare System, San Diego, CA|