Usefulness of Selegiline as an Aid to Quit Smoking - 1
Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Usefulness of Selegiline for Smoking Cessation|
- 7 Day Point Prevalence of Cigarette Abstinence [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
- 7 Day Point Prevalence of Cigarette Abstinence [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
Other Name: L-deprenyl; Eldepryl®
Placebo Comparator: 2
Despite the availability of nicotine replacement therapies and sustained-relapse bupropion for the treatment of nicotine dependence, there is still a significant proportion of cigarette smokers who are unable to quit smoking. Therefore, new and effective pharmacotherapies for smoking cessation are needed. The primary aim of this study is to determine the safety and efficacy of selegiline as an aid to smoking cessation.
In this study, 200 nicotine-dependent cigarette smokers will participate in an 8-week, double-blind, placebo-controlled trial and then will be followed over 4 years. Participants will be randomly assigned to receive either selegiline or placebo. Selegiline doses of 5 mg will be taken once a day during the first week. This will be increased to 5 mg twice daily for the remaining 7 weeks. The target smoking "quit date" will be Day 15. All smokers will receive brief weekly manualized smoking cessation counseling from the Mayo Clinic's "Smoke Free and Livin' It" program. The primary smoking cessation outcome measure will be 7-day point prevalence smoking abstinence at the 6-month follow-up. Secondary cessation outcome measures will include continuous smoking abstinence during the last four weeks of the trial (Days 29-56) and 7-day point prevalence abstinence at the end of the 8-week trial (Days 49-56).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129311
|United States, Connecticut|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Tony P George, M.D.||Yale University|
|Principal Investigator:||Marc N Potenza, M.D., Ph.D.||Yale University|