Selegiline Patch for Treatment of Nicotine Dependence

Phase 2

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Other: matching placebo; Drug: Selegiline

• Registration Number: NCT01330030
• Lead Sponsor: Stanford University

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.

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.

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2008-08
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Completion: 2011-07
• Results First Submitted: 2016-03-01
• Results First Submitted QC: 2016-03-03
• Results First Posted: 2016-04-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Smokes greater than 20 cigarettes per day

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Matching placebo	matching placebo	matching placebo worn 24 hours for 8 weeks
Drug Selegiline	Selegiline	6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks

Primary Outcome Measures

Name	Time	Method
Expired-air Carbon Monoxide Confirmed Smoking Abstinence	52 weeks	expired-air carbon monoxide confirmed smoking abstinence at 52 weeks

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States