An interventional study of Menthol-flavored electronic cigarette and Tobacco-flavored electronic cigarette in Smoking Reduction, sponsored by Nikki Nollen, PhD, MA. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Nikki Nollen, PhD, MA · Not applicable, Interventional, and Prevention
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.
Nikki Nollen, PhD, MA is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.
Other: Menthol-flavored electronic cigarette
400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.
Other: Tobacco-flavored electronic cigarette
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.
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.
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.
Time frame: Week 12
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.
Time frame: 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.
Time frame: Week 12
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Smoking Reduction