Selegiline Patch for Treatment of Nicotine Dependence

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Selegiline; Other: matching placebo

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 Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Selegiline; 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks	Drug: Selegiline; 6mg/24 hrs for 8 weeks; Other Names: EMSAM
Placebo Comparator: Matching placebo; matching placebo worn 24 hours for 8 weeks	Other: matching placebo; placebo/24hrs for 8 weeks; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expired-air Carbon Monoxide Confirmed Smoking Abstinence	expired-air carbon monoxide confirmed smoking abstinence at 52 weeks	52 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Joel D Killen, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Psychotropic Drugs; Antidepressive Agents; Monoamine Oxidase Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents; Selegiline
• Other Study ID Numbers: SU-07232007-459; R01DA017457 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No