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Effectiveness of the Selegiline Patch in Treating Nicotine Dependent Individuals

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218647
First received: September 20, 2005
Last updated: July 9, 2008
Last verified: July 2008
History of Changes
  Purpose

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 Intervention Phase
Tobacco Use Disorder
 Drug: Selegiline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selegiline Patch for Treatment of Nicotine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 7-day point prevalence of cigarette abstinence (measured weekly throughout the study) [ Time Frame: end of treatment, 6mos, 12mos ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: July 2005
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Selegiline
    placebo controlled examination of the effectiveness of a selegiline patch (20mg/d) in the treatment of nicotine dependence
    Other Name: Emsam
    Drug: Selegiline
    20 mg selegiline patch
    Other Name: Emsam
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218647

Locations
United States, California
Stanford Stop Smoking Program
Stanford, California, United States, 94305 5705
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Joel Killen, PhD Stanford University
  More Information

No publications provided

Responsible Party: Joel D. Killen, Stanford University
ClinicalTrials.gov Identifier: NCT00218647     History of Changes
Other Study ID Numbers: NIDA-17457-1, R01-17457-1, DPMC
Study First Received: September 20, 2005
Last Updated: July 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Selegiline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on May 21, 2013