Selegiline for Smoking Cessation - 1
Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
1 other identifier
interventional
246
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2007
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2007
CompletedFirst Posted
Study publicly available on registry
February 23, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
October 13, 2016
CompletedFebruary 2, 2017
December 1, 2016
1.2 years
February 22, 2007
August 17, 2016
December 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Study weeks 6 through 9
Secondary Outcomes (1)
Abstinence
week 14
Study Arms (2)
Selegiline Transdermal Patch
ACTIVE COMPARATORSubjects 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
Placebo
PLACEBO COMPARATORSubjects 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
Selegiline cm(2) via transdermal system
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Criteria:
- Please contact site for more information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Department of Public & Community Health
College Park, Maryland, 20745, United States
Robert Wood Johnson Med School-Tobacco Dep Program
New Brunswick, New Jersey, 08901, United States
Tri-State Tobacco and Alcohol Research Center
Cincinnati, Ohio, 45237, United States
Center For Tobacco Research and Intervention
Milwaukee, Wisconsin, 53233, United States
Related Publications (2)
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.
PMID: 21846661RESULTHajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PMID: 37230961DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Liza Zeinert
- Organization
- National Institute on Drug Abuse
Study Officials
- PRINCIPAL INVESTIGATOR
Elbert D Glover, Ph.D.
VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2007
First Posted
February 23, 2007
Study Start
June 1, 2007
Primary Completion
August 1, 2008
Study Completion
January 1, 2009
Last Updated
February 2, 2017
Results First Posted
October 13, 2016
Record last verified: 2016-12