Selegiline Patch for Treatment of Nicotine Dependence
2 other identifiers
interventional
243
1 country
1
Brief Summary
Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
Longer than P75 for phase_2
1 active site
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
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
April 4, 2016
CompletedAugust 10, 2016
May 1, 2016
3.1 years
November 8, 2010
March 1, 2016
June 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Expired-air Carbon Monoxide Confirmed Smoking Abstinence
expired-air carbon monoxide confirmed smoking abstinence at 52 weeks
52 weeks
Study Arms (2)
Drug Selegiline
EXPERIMENTAL6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
Matching placebo
PLACEBO COMPARATORmatching placebo worn 24 hours for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Smokes greater than 20 cigarettes per day
You may not qualify if:
- History of Parkinson's disease, high blood pressure, or severe liver or kidney disease
- Current substance abuse
- Mental illness
- Skin conditions that could interfere with patch use
- Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO inhibitor)
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (2)
Killen JD, Fortmann SP, Murphy GM Jr, Hayward C, Fong D, Lowenthal K, Bryson SW, Killen DT, Schatzberg AF. Failure to improve cigarette smoking abstinence with transdermal selegiline + cognitive behavior therapy. Addiction. 2010 Sep;105(9):1660-8. doi: 10.1111/j.1360-0443.2010.03020.x.
PMID: 20707784RESULTHajizadeh 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Joel D Killen
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Joel D Killen
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 8, 2010
First Posted
April 6, 2011
Study Start
July 1, 2005
Primary Completion
August 1, 2008
Study Completion
July 1, 2011
Last Updated
August 10, 2016
Results First Posted
April 4, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share