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Selegiline for Smoking Cessation - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00439413
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : October 13, 2016
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Nicotine Dependence Drug: Selegiline Transdermal Patch Drug: Placebo Behavioral: Smoking Cessation Counseling Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
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.
Study Start Date : June 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : January 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439413


Locations
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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
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Principal Investigator: Elbert D Glover, Ph.D. VA Medical Center
More Information
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Publications of Results:

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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00439413    
Obsolete Identifiers: NCT00462514
Other Study ID Numbers: NIDA-CSP-1022-1
First Posted: February 23, 2007    Key Record Dates
Results First Posted: October 13, 2016
Last Update Posted: February 2, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Selegiline
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
 Anti-Dyskinesia Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs