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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA210625-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.
Eligible smokers, once consented, will be randomized to receive a sample of ecigarettes (NJoy Pre-Filled Tank; n=440) or not (n=220). E-cigarette samples are inclusive of a battery and self-contained tanks of assorted flavors to last up to 4 weeks. Participants will be recruited nationally, but a subset (N=120) will be recruited locally to allow for biomarker collection . Our two-fold purpose is to 1) characterize naturalistic uptake of e-cigarettes, and 2) assess impact of e-cigarette uptake on smoking behavior. All smokers will be asked to provide smoking diary data, captured electronically, daily for 4 weeks. More substantive phone assessment will track smoking and related behaviors at baseline (Day 0) and +10, +17, and +24 days (weekly during initial 3 weeks, following brief lag for delays in product mailing), and at +1, +3, and +6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. | |
| Sampling | Experimental | Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Cigarette | Behavioral | An e-cigarette and four weeks of e-liquid provided to participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| E-cig Use at End of Sampling Period | percentage of participants reporting using an e-cigarette | at week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion | Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own | Study enrollment through end of 6-month follow up |
| Smoking Cessation | Point prevalence abstinence from conventional smoking |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37753443 | Derived | Carpenter MJ, Wahlquist AE, Dahne J, Gray KM, Cummings KM, Warren G, Wagener TL, Goniewicz ML, Smith TT. Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial. EClinicalMedicine. 2023 Aug 15;63:102142. doi: 10.1016/j.eclinm.2023.102142. eCollection 2023 Sep. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. |
| FG001 | Sampling | Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. |
| BG001 | Sampling |
| 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 | E-cig Use at End of Sampling Period | percentage of participants reporting using an e-cigarette | Posted | Number | percentage of participants | at week 4 |
|
study weeks 1 through 24
AEs are asked of both groups at follow-up calls at Weeks 1, 2, 3, 4, 12, and 24.
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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 | Control | Participants will not receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma-induced hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Carpenter | Medical University of South Carolina (MUSC) | 843-876-2436 | carpente@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 | Nov 1, 2021 | Aug 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| at 6-month follow-up |
Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like.
Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Motivation to Quit Smoking (0-10 scale) | 0 is the lowest motivation and 10 is the highest motivation | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Conversion | Percentage of participants who purchase an e-cigarette or additional nicotine liquid on their own | Posted | Number | percentage of participants | Study enrollment through end of 6-month follow up |
|
|
|
| Secondary | Smoking Cessation | Point prevalence abstinence from conventional smoking | Posted | Number | percentage of participants | at 6-month follow-up |
|
|
|
| 0 |
| 211 |
| 0 |
| 211 |
| 98 |
| 211 |
| EG001 | Sampling | Participants will receive an NJOY electronic cigarette to sample and will continue smoking their usual cigarettes as much or as little as they would like. Electronic Cigarette: An e-cigarette and four weeks of e-liquid provided to participants. | 0 | 427 | 1 | 427 | 177 | 427 |
| headache | Nervous system disorders | Systematic Assessment |
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| increased phlegm | Gastrointestinal disorders | Systematic Assessment |
|
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