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Selegiline for Smoking Cessation - 1

This study has been completed.
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00439413
First received: February 22, 2007
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
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 Transdermal Patch Drug: Placebo Behavioral: Smoking Cessation Counseling Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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: Study weeks 6 through 9 ]
    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 ]
    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
Active Comparator: 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

Drug: Selegiline Transdermal Patch
Selegiline cm(2) via transdermal system
Other Name: STS Patch
Behavioral: Smoking Cessation Counseling
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Placebo Comparator: 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

Drug: Placebo
Matching placebo via transdermal system
Other Name: Placebo Patch
Behavioral: Smoking Cessation Counseling
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  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 ClinicalTrials.gov identifier: NCT00439413

Locations
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
Investigators
Principal Investigator: Elbert D Glover, Ph.D. VA Office of Research and Development
  More Information

Publications:
Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov 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: December 7, 2016

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017