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Selegiline Patch for Treatment of Nicotine Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joel D Killen, Stanford University
ClinicalTrials.gov Identifier:
NCT01330030
First received: November 8, 2010
Last updated: June 29, 2016
Last verified: May 2016
  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
Other: matching placebo
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:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Expired-air Carbon Monoxide Confirmed Smoking Abstinence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    expired-air carbon monoxide confirmed smoking abstinence at 52 weeks


Enrollment: 243
Study Start Date: July 2005
Study Completion Date: July 2011
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330030

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

Publications:
Responsible Party: Joel D Killen, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01330030     History of Changes
Obsolete Identifiers: NCT00218647
Other Study ID Numbers: SU-07232007-459  R01DA017457 
Study First Received: November 8, 2010
Results First Received: March 1, 2016
Last Updated: June 29, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
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

ClinicalTrials.gov processed this record on December 07, 2016