Selegiline Patch for Treatment of Nicotine Dependence

Tobacco Use Disorder Clinical Trial

Official title:

Selegiline Patch for Treatment of Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330030
• Other study ID #: SU-07232007-459
• Secondary ID: R01DA017457
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2010
• Last updated: June 25, 2013
• Start date: July 2005
• Est. completion date: July 2011

Study information

• Verified date: June 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00218647

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 2011
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Selegiline
6mg/24 hrs for 8 weeks

Other:
• matching placebo
placebo/24hrs for 8 weeks

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expired-air carbon monoxide confirmed smoking abstinence	expired-air carbon monoxide confirmed smoking abstinence	52 weeks	No