Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Selegiline for Smoking Cessation - 1

This study has been completed.
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA) Identifier:
First received: February 22, 2007
Last updated: August 17, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Nicotine Dependence
Drug: Selegiline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Quit Rate [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
    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:
  • Abstinence [ Time Frame: week 14 ] [ Designated as safety issue: No ]
    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.

Enrollment: 246
Study Start Date: June 2007
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Selegiline
Placebo Comparator: 2 Drug: Placebo


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.



  • Please contact site for more information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00439413

United States, Maryland
Department of Public & Community Health
College Park, Maryland, United States, 20745
United States, New Jersey
Robert Wood Johnson Med School-Tobacco Dep Program
New Brunswick, New Jersey, United States, 08901
United States, Ohio
Tri-State Tobacco and Alcohol Research Center
Cincinnati, Ohio, United States, 45237
United States, Wisconsin
Center For Tobacco Research and Intervention
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
VA Office of Research and Development
Principal Investigator: Elbert D Glover, Ph.D. VA Office of Research and Development
  More Information

Responsible Party: National Institute on Drug Abuse (NIDA) Identifier: NCT00439413     History of Changes
Obsolete Identifiers: NCT00462514
Other Study ID Numbers: NIDA-CSP-1022-1 
Study First Received: February 22, 2007
Results First Received: August 17, 2016
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders processed this record on December 05, 2016