Selegiline for Smoking Cessation - 1

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Selegiline Transdermal Patch
* Drug: Placebo
* Behavioral: Smoking Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selegiline Transdermal Patch<br>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 | Drug: Selegiline Transdermal Patch<br>* Selegiline cm(2) via transdermal system<br>* Other names: STS Patch;Behavioral: Smoking Cessation Counseling<br>* Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks<br>|
| Placebo Comparator: Placebo<br>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 | Drug: Placebo<br>* Matching placebo via transdermal system<br>* Other names: Placebo Patch;Behavioral: Smoking Cessation Counseling<br>* Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit Rate | 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). | Study weeks 6 through 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence | 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. | week 14 |