Selegiline Patch for Treatment of Nicotine Dependence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Selegiline for Smoking Cessation - 1

NCT00439413

Nicotine Dependence

COMPLETED PHASE2

Usefulness of Selegiline as an Aid to Quit Smoking - 1

NCT00129311

Tobacco Use Cessation

COMPLETED PHASE2

Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence

NCT00390923

Nicotine Dependence

TERMINATED NA

Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers

NCT01048944

Nicotine Dependence

COMPLETED PHASE4

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

NCT00365508

Bladder Cancer Cervical Cancer Esophageal Cancer +8 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug Selegiline

6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks

Group Type EXPERIMENTAL

Selegiline

Intervention Type DRUG

6mg/24 hrs for 8 weeks

Matching placebo

matching placebo worn 24 hours for 8 weeks

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type OTHER

placebo/24hrs for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Selegiline

6mg/24 hrs for 8 weeks

Intervention Type DRUG

matching placebo

placebo/24hrs for 8 weeks

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EMSAM Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes