Selegiline for Smoking Cessation - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence

Treatments: Behavioral: Smoking Cessation Counseling; Drug: Selegiline Transdermal Patch; Drug: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT00439413

NIDA-CSP-1022-1

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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246 participants in 2 patient groups, including a placebo group

Selegiline Transdermal Patch

Active Comparator group

Description:

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

Treatment:

Drug: Selegiline Transdermal Patch

Behavioral: Smoking Cessation Counseling

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Behavioral: Smoking Cessation Counseling