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IND required
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This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-Cigarette | Experimental | STAM 1100mAh CE4 eGo Clearomizer e-Cigarette |
|
| Nicotine polacrilex | Active Comparator | Nicotine Replacement gum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine polacrilex | Drug | 2 mg and 4 mg gum will be used according to the FDA approved product labelling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Abstinence | No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Point Prevalence Abstinence | No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy J Arouni, MD | Creighton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University | Omaha | Nebraska | 68178 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | e-Cigarette | STAM 1100mAh CE4 eGo Clearomizer e-Cigarette |
| FG001 | Nicotine Polacrilex | Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | e-Cigarette | STAM 1100mAh CE4 eGo Clearomizer e-Cigarette |
| BG001 | Nicotine Polacrilex | Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling |
| 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 | Sustained Abstinence | No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine. | Posted | Number | participants | 12 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 | e-Cigarette | STAM 1100mAh CE4 eGo Clearomizer e-Cigarette |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throat dry/irritated | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Creighton University | 402-280-4961 | sandrabyers@creighton.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 |
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| STAM 1100mAh CE4 eGo Clearomizer | Other |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Point Prevalence Abstinence | No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine. | Posted | Number | participants | 12 weeks |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Nicotine Polacrilex | Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling | 0 | 5 | 0 | 5 |
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| D001519 | Behavior |
| D012907 | Smoking |
| Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |