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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA055985-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Minnesota | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol Spectrum Cigarettes and Menthol E-cigarettes | Experimental | Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
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| Menthol Spectrum Cigarettes and Tobacco E-cigarettes | Experimental | Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
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| Non-menthol Spectrum Cigarettes and Menthol E-cigarettes | Experimental | Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
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| Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes | Experimental | Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Menthol Cigarettes | Behavioral | Ppts will be randomly assigned to a group that receives non-menthol cigarettes |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in cigarettes per day | Will be measured through week 6 of the study | Week 1- Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Fagerstrom Test for Nicotine Dependence | Cigarette Dependence | Week 1- Week 7 |
| Ability to abstain from smoking | Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy T Smith | Contact | 8437925164 | smithtra@musc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Tobacco Flavored E-cigarettes | Behavioral | Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes |
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| Menthol Cigarettes | Behavioral | Ppts will be randomly assigned to a group that receives menthol flavored cigarettes |
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| Menthol Flavored E-cigarettes | Behavioral | Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes |
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| Week 7 |
| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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