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The majority of smokers try to quit each year, and the majority of quit attempts fail, even when the most effective FDA-approved pharmacotherapies are used. Non-combustible tobacco products emit fewer harmful chemicals than cigarettes, and thus for smokers who cannot quit smoking, switching completely to a less harmful product is likely to improve their risk of cancer and other deleterious health outcomes. E-cigarettes, the most commonly used non-cigarette tobacco product, have been shown to deliver sufficient nicotine, be appealing to smokers, and reduce cigarette smoking when provided to smokers to use ad libitum. For smokers who have failed to quit with traditional methods, trying to switch to a less harmful product may be more likely to help them stop smoking than trying to quit using tobacco altogether repeatedly with pharmacotherapy. The proposed trial evaluates the potential of e-cigarettes to serve as harm reduction tools for current smokers who have already tried, and failed, to quit with traditional methods. Current smokers who failed to quit with FDA-approved pharmacotherapy within the past year (N=30) will be randomly assigned to either 1) switch completely to e-cigarettes (Switch Group, n=20), or 2) try to quit again using pharmacotherapy (Meds Group, n=10). Thus, our design is strengthened by a strong active control group. Participants will select a Target Switch / Quit Date on which they will stop smoking. Participants in the Switch group will receive a 5-week supply of JUUL e-cigarettes, the most popular e-cigarette currently available. Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Participants will use 1-week of their tobacco product or medication ad libitum while continuing to smoke in advance of their Target Switch / Quit Date, and 4-weeks as instructed following a Target Switch or Quit Date. Behavioral outcomes of interest include smoking reduction > 50% and biochemically-confirmed abstinence from cigarette smoking at 4-weeks. The proposed trial addresses a highly significant research question using a rigorous design and is supported by a strong investigative team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch Group | Experimental | Participants in the Switch group will receive a 5-week supply of e-cigarettes. |
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| Meds Group | Active Comparator | Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-cigarette | Behavioral | Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Report Daily Use of E-cigarettes or NRT and no Cigarette Use | daily use of e-cigarette or NRT instead of cigarettes | day 0 through day 35 |
| Percentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 4 | Self reported point prevalence abstinence from cigarettes and expired carbon monoxide < 6 ppm | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Switch Group | Participants in the Switch group will receive a 5-week supply of e-cigarettes. e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product. |
| FG001 | Meds Group | Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Switch Group | Participants in the Switch group will receive a 5-week supply of e-cigarettes. e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product. |
| BG001 | Meds Group |
| 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 | Percentage of Participants Who Report Daily Use of E-cigarettes or NRT and no Cigarette Use | daily use of e-cigarette or NRT instead of cigarettes | Not Posted | day 0 through day 35 | Participants | |||||||||||
| Primary | Percentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 4 | Self reported point prevalence abstinence from cigarettes and expired carbon monoxide < 6 ppm | Posted | Count of Participants | Participants |
5 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 | Switch Group | Participants in the Switch group will receive a 5-week supply of e-cigarettes. e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Thoughts | Psychiatric disorders | Non-systematic Assessment | Severe suicidal thoughts |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning, mucus, or irritation in the throat/sinuses | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Smith, PhD | Medical University of South Carolina | 843 792 5164 | smithtra@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2023 | Nov 2, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2022 | Oct 11, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D013812 | Therapeutics |
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| Nicotine patch, Nicotine lozenge | Other | Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided. |
|
Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Week 4 |
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|
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| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Meds Group | Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided. | 0 | 10 | 1 | 10 | 10 | 10 |
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| Changes in taste/dry mouth | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dry Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Insomnia or dream abnormalities | Nervous system disorders | Systematic Assessment |
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| Nausea, flatulence, or stomachache | Gastrointestinal disorders | Systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Throat or mouth irritation/ulcers | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vertigo or Dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| headaches | Cardiac disorders | Systematic Assessment |
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| heartburn | Gastrointestinal disorders | Systematic Assessment |
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| short of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| brochitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| increased mucus / phlegm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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