Back to resultsSelegiline for Smoking Cessation - 1
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Selegiline Transdermal Patch
Placebo
Smoking Cessation Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence
Eligibility 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
Sites / Locations
- Department of Public & Community Health
- Robert Wood Johnson Med School-Tobacco Dep Program
- Tri-State Tobacco and Alcohol Research Center
- Center For Tobacco Research and Intervention
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Selegiline Transdermal Patch
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00439413
First Posted
February 22, 2007
Last Updated
December 7, 2016
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00439413
Brief Title
Selegiline for Smoking Cessation - 1
Official Title
Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selegiline Transdermal Patch
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Selegiline Transdermal Patch
Other Intervention Name(s)
STS Patch
Intervention Description
Selegiline cm(2) via transdermal system
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Patch
Intervention Description
Matching placebo via transdermal system
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation Counseling
Intervention Description
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Primary Outcome Measure Information:
Title
Quit Rate
Description
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 Outcome Measure Information:
Title
Abstinence
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elbert D Glover, Ph.D.
Organizational Affiliation
VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Public & Community Health
City
College Park
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Robert Wood Johnson Med School-Tobacco Dep Program
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Tri-State Tobacco and Alcohol Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45237
Country
United States
Facility Name
Center For Tobacco Research and Intervention
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21846661
Citation
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.
Results Reference
result
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Selegiline for Smoking Cessation - 1
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