Selegiline Patch for Treatment of Nicotine Dependence
Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tobacco Use Disorder
Intervention: Selegiline (Drug); matching placebo (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Stanford University Official(s) and/or principal investigator(s): Joel D Killen, Principal Investigator, Affiliation: Stanford University
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.
Clinical Details
Official title: Selegiline Patch for Treatment of Nicotine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: expired-air carbon monoxide confirmed smoking abstinence
Detailed description:
Most smokers relapse following smoking cessation treatment. More effective smoking
cessation therapies are needed to prevent the high rates of relapse. Selegiline is a
selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in
combination with levodopa to treat Parkinson's disease. Selegiline permits the stabilization
of dopamine (DA) levels in the brain by preventing the rapid degradation of DA by means of
MAO B and is used as an adjunct to levodopa therapy causing a dose-sparing effect and
enhancing dopaminergic transmission. Selegiline's effect on MAO B and the resulting effect
on brain DA has interesting implications for the treatment of nicotine dependence because
brain DA systems may play a key role in the mediation of reward learning behavior. Previous
research suggests that the brains of living smokers show a 40% decrease in the level of MAO
B relative to nonsmokers or former smokers. The purpose of this study is examine whether
selegiline, administered in the form of a skin patch, is effective for smoking cessation.
Participants will be randomly assigned to one of two treatments: 1) transdermal selegiline
patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8
weeks. Participants will be stratified by gender to evaluate the role that gender plays in
moderating smoking cessation treatment. Study visits will take place once each week for 30
to 45 minutes, and will include adverse events monitoring, biochemical verification of
smoking status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to
determine response to treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Smokes greater than 20 cigarettes per day
Exclusion Criteria:
- 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
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: July 2005
Last updated: June 25, 2013
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