NCT05555069

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Nikki Nollen, PhD, MA · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Smoking Reduction

Interventions

Type	Name	Description
OTHER	Menthol-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.
OTHER	Tobacco-flavored electronic cigarette	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.

Timeline

• Start date: 2022-11-08
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2022-09-26
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States