Selegiline Patch for Treatment of Nicotine Dependence
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | July 2005 |
| End Date: | July 2011 |
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.
this study is examine whether selegiline, given in the form of a skin patch, is effective in
stopping smoking.
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.
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.
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
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Stanford University School of Medicine Vast in both its physical scale and its impact on...
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