| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017457 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Selegiline | Experimental | 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks |
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| Matching placebo | Placebo Comparator | matching placebo worn 24 hours for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selegiline | Drug | 6mg/24 hrs for 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Expired-air Carbon Monoxide Confirmed Smoking Abstinence | expired-air carbon monoxide confirmed smoking abstinence at 52 weeks | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel D Killen | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20707784 | Result | 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. | |
| 37230961 | Derived | Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. |
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The original target enrollment was 230. Over recruitment led to a study sample size =243
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Selegiline | 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks |
| FG001 | Matching Placebo | matching placebo worn 24 hours for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug Selegiline | 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks Selegiline: 6mg/24 hrs for 8 weeks |
| BG001 | Matching Placebo | matching placebo worn 24 hours for 8 weeks matching placebo: placebo/24hrs for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Expired-air Carbon Monoxide Confirmed Smoking Abstinence | expired-air carbon monoxide confirmed smoking abstinence at 52 weeks | intention to treat | Posted | Number | participants not smoking | 52 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drug Selegiline | 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks Selegiline: 6mg/24 hrs for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Joel D Killen | Stanford University | 650-723-5895 | jkillen@stanford.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012642 | Selegiline |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| matching placebo | Other | placebo/24hrs for 8 weeks |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 121 |
| 110 |
| 121 |
| EG001 | Matching Placebo | matching placebo worn 24 hours for 8 weeks matching placebo: placebo/24hrs for 8 weeks | 0 | 122 | 108 | 122 |
| Headache | General disorders | Systematic Assessment |
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| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| racing thoughts | Psychiatric disorders | Systematic Assessment |
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| Lightheaded | General disorders | Systematic Assessment |
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| Vivid dreams | Psychiatric disorders | Systematic Assessment |
|
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