Selegiline for Smoking Cessation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-01-31

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.

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Detailed Description

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Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Selegiline Transdermal Patch

Intervention Type DRUG

Selegiline cm(2) via transdermal system

Smoking Cessation Counseling

Intervention Type BEHAVIORAL

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo via transdermal system

Smoking Cessation Counseling

Intervention Type BEHAVIORAL

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

Interventions

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Selegiline Transdermal Patch

Selegiline cm(2) via transdermal system

Intervention Type DRUG

Placebo

Matching placebo via transdermal system

Intervention Type DRUG

Smoking Cessation Counseling

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

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STS Patch Placebo Patch

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:

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Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes