Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
|ClinicalTrials.gov Identifier: NCT00802412|
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence Alcohol Dependence||Drug: Topiramate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men|
|Study Start Date :||January 2009|
|Primary Completion Date :||November 2014|
|Study Completion Date :||June 2015|
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: Placebo
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.
- 4-week Continuous Abstinence From Smoking [ Time Frame: Weeks 8-12 of treatment. ]This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
- Percent Relapsing to Any Drinking or Illicit Drug Use [ Time Frame: 12-week treatment phase, 36-week combined treatment and follow-up ]Alcohol or illicit drug use during treatment or follow up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802412
|United States, California|
|VA San Diego Healthcare System, San Diego, CA|
|San Diego, California, United States, 92161|
|Principal Investigator:||Robert M. Anthenelli, MD||VA San Diego Healthcare System, San Diego, CA|