Clinical trial NCT01330030: Selegiline Patch for Treatment of Nicotine Dependence
Official title: Selegiline Patch for Treatment of Nicotine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-06
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Expired-air Carbon Monoxide Confirmed Smoking Abstinence
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Joel D Killen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.