Tobacco Use Cessation Clinical Trial
Official title:
Usefulness of Selegiline for Smoking Cessation
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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