Smoking Reduction Clinical Trial
Official title:
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
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.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | November 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Nikki Nollen, PhD, MA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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