The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

Conditions
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Smoking Reduction

Intervention / Treatment
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* Other: Menthol-flavored electronic cigarette
* Other: Tobacco-flavored electronic cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 21 years of age Smoke ≥ 5 cigarettes per day (CPD) Smoke menthol cigarettes for ≥ 6 months Verified smoker (CO >5ppm) Functioning telephone Interested in switching to E-cigarettes Exclusion Criteria: Interested in quitting smoking Use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes) E-cigarette use on ≥ 4 of the past 30 days Uncontrolled hypertension: BP ≥ 180(systolic) or ≥ 105 (diastolic) Use of smoking cessation pharmacotherapy in the month prior to enrollment Pregnant, contemplating getting pregnant, or breastfeeding Plans to move from Kansas City during the treatment and follow-up phase Another household member enrolled in the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Menthol Flavor Electronic Cigarette<br>400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes. | Other: Menthol-flavored electronic cigarette<br>* 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.<br>|
| Active Comparator: Tobacco Flavor Electronic Cigarette<br>400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes. | Other: Tobacco-flavored electronic cigarette<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |