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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selegiline Transdermal Patch | Active Comparator | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks |
|
| Placebo | Placebo Comparator | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selegiline Transdermal Patch | Drug | Selegiline cm(2) via transdermal system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quit Rate | The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9). | Study weeks 6 through 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence | The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group. | week 14 |
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Inclusion Criteria:
Exclusion
Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elbert D Glover, Ph.D. | VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Public & Community Health | College Park | Maryland | 20745 | United States | ||
| Robert Wood Johnson Med School-Tobacco Dep Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21846661 | Result | Kahn R, Gorgon L, Jones K, McSherry F, Glover ED, Anthenelli RM, Jackson T, Williams J, Murtaugh C, Montoya I, Yu E, Elkashef A. Selegiline transdermal system (STS) as an aid for smoking cessation. Nicotine Tob Res. 2012 Mar;14(3):377-82. doi: 10.1093/ntr/ntr143. Epub 2011 Aug 16. | |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Selegiline Transdermal System | Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks |
| FG001 | Placebo | Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Selegiline Transdermal System | Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks |
| BG001 | Placebo | Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Quit Rate | The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9). | Posted | Number | participants | Study weeks 6 through 9 |
|
Week 2 through 9 and follow-up weeks (10 and 14)
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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 | Selegiline Transdermal System | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture of femur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liza Zeinert | National Institute on Drug Abuse | 301-443-1138 | liza.zeinert@nih.gov |
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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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| Placebo | Drug | Matching placebo via transdermal system |
|
|
| Smoking Cessation Counseling | Behavioral | Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks |
|
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Tri-State Tobacco and Alcohol Research Center | Cincinnati | Ohio | 45237 | United States |
| Center For Tobacco Research and Intervention | Milwaukee | Wisconsin | 53233 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.
During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.
Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.
|
|
| Secondary | Abstinence | The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group. | Posted | Number | participants | week 14 |
|
|
|
| 3 |
| 121 |
| 99 |
| 121 |
| EG001 | Matching Placebo | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks. | 0 | 125 | 76 | 125 |
| Heart Attack | Cardiac disorders | Systematic Assessment |
|
| Exacerbation of COPD dut to pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Application Site Erythema | General disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
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| Vision blurred | Eye disorders | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
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| Hypersensitivity | Hepatobiliary disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Hot flush | Vascular disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
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