This clinical trial evaluates the impact of cigarette and electronic (e)-cigarette menthol ban on current smokers of menthol cigarettes. Menthol is added to cigarettes as a flavoring and is intended to reduce irritation and harshness, however, the use of menthol may increase the initiation of smoking and increase dependence on cigarettes smoking. The Federal Drug Administration is planning to implement a ban on menthol for use as a flavoring in cigarettes. Smokers may move to alternative and less harmful sources, such as e-cigarettes, although there is some concern that a potential ban on menthol in e-cigarettes may result in smokers continuing to smoke cigarettes. The ban on menthol flavoring may have a negative impact on the use of cigarettes and e-cigarettes and may reduce smoking cessation attempts in current smokers of menthol cigarettes.
Additional locations may be listed on ClinicalTrials.gov for NCT05896033.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Tracy Smith
Phone: 843-792-5164
Florence
MUSC Health Florence Medical CenterStatus: Active
Contact: Tracy Smith
Lancaster
MUSC Health Lancaster Medical CenterStatus: Active
Contact: Tracy Smith
PRIMARY OBJECTIVES:
I. Assess the impact of simulated cigarette and e-cigarette menthol regulations on tobacco use patterns among current menthol smokers.
II. Evaluate the impact of simulated cigarette and e-cigarette menthol regulations on cigarette and e-cigarette subjective effects, and dependence.
III. Describe the heterogeneity of the impact of simulated cigarette and e-cigarette menthol regulations, calibrate the effect to the United States (US) adult menthol smoking population, and model the impact on smoking and vaping attributable death and life years lost.
OUTLINE: Participants are randomized to 1 of 4 arms.
ARM I: Participants receive menthol cigarettes and menthol flavored e-cigarettes and smoke only these products for up to 6 weeks. Participants may optionally receive nicotine patches throughout study. Participants attempt cigarette smoking cessation but may use e-cigarettes and nicotine patches during week 7. Additionally, participants undergo measurement of carbon monoxide at weekly visits and twice daily (BID) for 7 weeks on study.
ARM II: Participants receive menthol cigarettes and tobacco flavored e-cigarettes and smoke only these products for up to 6 weeks. Participants may optionally receive nicotine patches throughout study. Participants attempt cigarette smoking cessation but may use e-cigarettes and nicotine patches during week 7. Additionally, participants undergo measurement of carbon monoxide at weekly visits and BID for 7 weeks on study.
ARM III: Participants receive non-menthol cigarettes and menthol flavored e-cigarettes and smoke only these products for up to 6 weeks. Participants may optionally receive nicotine patches throughout study. Participants attempt cigarette smoking cessation but may use e-cigarettes and nicotine patches during week 7. Additionally, participants undergo measurement of carbon monoxide at weekly visits and BID for 7 weeks on study.
ARM IV: Participants receive non-menthol cigarettes and tobacco flavored e-cigarettes and smoke only these products for up to 6 weeks. Participants may optionally receive nicotine patches throughout study. Participants attempt cigarette smoking cessation but may use e-cigarettes and nicotine patches during week 7. Additionally, participants undergo measurement of carbon monoxide at weekly visits and BID for 7 weeks on study.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedical University of South Carolina
Principal InvestigatorTracy Smith
