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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)

Tracking Information
First Submitted Date  ICMJE February 22, 2007
First Posted Date  ICMJE February 23, 2007
Results First Submitted Date  ICMJE August 17, 2016
Results First Posted Date  ICMJE October 13, 2016
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE June 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2007)
Quit Rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2007)
  • Craving
  • Depression
  • Mood
  • Safety
  • Abstinence
  • Weight gain / loss
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selegiline for Smoking Cessation - 1
Official Title  ICMJE Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • Drug: Selegiline Transdermal Patch
    Selegiline cm(2) via transdermal system
    Other Name: STS Patch
  • 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
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Selegiline Transdermal Patch
    • Behavioral: Smoking Cessation Counseling
  • 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

    Interventions:
    • Drug: Placebo
    • Behavioral: Smoking Cessation Counseling
Publications * Kahn R, Gorgon L, Jones K, McSherry F, Glover ED, Anthenelli RM, Jackson T, Williams J, Murtaugh C, Montoya I, Yu E, Elkashef A. Selegiline transdermal system (STS) as an aid for smoking cessation. Nicotine Tob Res. 2012 Mar;14(3):377-82. doi: 10.1093/ntr/ntr143. Epub 2011 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2007)
246
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00439413
Other Study ID Numbers  ICMJE NIDA-CSP-1022-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute on Drug Abuse (NIDA)
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE VA Office of Research and Development
Investigators  ICMJE
Principal Investigator: Elbert D Glover, Ph.D. VA Medical Center
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP