Selegiline Patch for Treatment of Nicotine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01330030
Recruitment Status : Completed
First Posted : April 6, 2011
Results First Posted : April 4, 2016
Last Update Posted : August 10, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joel D Killen, 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Selegiline Other: matching placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selegiline Patch for Treatment of Nicotine Dependence
Study Start Date : July 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Selegiline

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 Name: EMSAM

Placebo Comparator: Matching placebo
matching placebo worn 24 hours for 8 weeks
Other: matching placebo
placebo/24hrs for 8 weeks
Other Name: Placebo

Primary Outcome Measures :
  1. Expired-air Carbon Monoxide Confirmed Smoking Abstinence [ Time Frame: 52 weeks ]
    expired-air carbon monoxide confirmed smoking abstinence at 52 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01330030

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Joel D Killen Stanford University

Publications of Results:
Responsible Party: Joel D Killen, Principle Investigator, Stanford University Identifier: NCT01330030     History of Changes
Obsolete Identifiers: NCT00218647
Other Study ID Numbers: SU-07232007-459
R01DA017457 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2011    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: August 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action