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This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers.
Menthol smokers (n=800), stratified by race, will be randomized 1:1 into a 12-week open label, non-inferiority trial comparing a 4th generation nicotine salt-based pod-system e-cigarette in menthol- versus tobacco-flavored e-liquid. Follow-up will continue through week 26. The primary outcome is rate of switching from combustible cigarettes to e-cigarettes at week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol Flavor Electronic Cigarette | Active Comparator | 400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes. |
|
| Tobacco Flavor Electronic Cigarette | Active Comparator | 400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menthol-flavored electronic cigarette | Other | Participants will receive 12 weeks of menthol -flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who switch from cigarettes to electronic cigarettes at Week 12 | Complete switching is defined as exclusive use of e-cigarettes, confirmed with CO< 6ppm and predominant switching; defined as use of the e-cigarette with >50% reduction in CPD. This will compare the effectiveness of menthol versus tobacco e-cigarettes at facilitating switching at Week 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of respiratory symptoms using spirometry | Spirometry summarizing forced expiratory flow (FEF) 25-75% and the American Thoracic Society Questionnaire will assess will assess acute respiratory symptoms experienced by cigarette and electronic cigarette smokers. This will help assess the tobacco harm reduction of electronic cigarettes. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tricia Snow | Contact | 816-398-8960 | psnow@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Nollen, PhD | University of Kanas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Missouri | 64130 | United States |
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| ID | Term |
|---|---|
| D000074264 | Smoking Reduction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
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| Tobacco-flavored electronic cigarette | Other | Participants will receive 12 weeks of tobacco-flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes. |
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| Amount of e-liquid consumed | E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes. | Week 12 |