Selegiline for Smoking Cessation - 1

National Institute on Drug Abuse (NIDA)246 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

246

Conditions

Nicotine Dependence

Interventions

Selegiline Transdermal PatchDRUG

Selegiline cm(2) via transdermal system

PlaceboDRUG

Matching placebo via transdermal system

Smoking Cessation CounselingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Department of Public & Community Health

College Park, Maryland, United States

Robert Wood Johnson Med School-Tobacco Dep Program

New Brunswick, New Jersey, United States

Tri-State Tobacco and Alcohol Research Center

Cincinnati, Ohio, United States

Center For Tobacco Research and Intervention

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

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).

Time frame: Study weeks 6 through 9

Secondary Outcomes

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.

Time frame: week 14

Data from ClinicalTrials.gov

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