Selegiline for Smoking Cessation - 1
- Conditions
- Nicotine Dependence
- Interventions
- Registration Number
- NCT00439413
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
- Must be at least 18 years of age
- Be in good general health
- Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
- Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5 years
- Subjects must be motivated to quite smoking
- If female and of child bearing potential, agrees to use birth control and subject
- Subject must be able to understand and provide written informed consent.
Exclusion
Criteria:
- Please contact site for more information
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Selegiline Transdermal Patch Selegiline Transdermal Patch Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks Selegiline Transdermal Patch Smoking Cessation Counseling Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks Placebo Placebo Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks Placebo Smoking Cessation Counseling Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
- Primary Outcome Measures
Name Time Method Quit Rate Study weeks 6 through 9 The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).
- Secondary Outcome Measures
Name Time Method Abstinence week 14 The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.
Trial Locations
- Locations (4)
Department of Public & Community Health
🇺🇸College Park, Maryland, United States
Tri-State Tobacco and Alcohol Research Center
🇺🇸Cincinnati, Ohio, United States
Center For Tobacco Research and Intervention
🇺🇸Milwaukee, Wisconsin, United States
Robert Wood Johnson Med School-Tobacco Dep Program
🇺🇸New Brunswick, New Jersey, United States