This clinical trial evaluates the impact of very low nicotine content (VLNC) cigarettes plus tobacco flavored and non-tobacco flavored or tobacco flavored only electronic (e)-cigarettes on cigarette smoking behavior. The Food and Drug Administration (FDA) intends to reduce nicotine in cigarettes, such as in VLN® cigarettes, to levels below the point that could lead to addiction. Reducing the nicotine level in cigarettes may lead a smoker to choose other less harmful products that contain nicotine, such as alternative nicotine delivery systems (ANDS), including e-cigarettes, nicotine pouches and smokeless tobacco products. In addition, the FDA weighs the benefits and risks of tobacco flavored and non-tobacco flavored products on health. A small study suggests that the availability of both tobacco flavored and non-tobacco flavored products may reduce smoking of VLNC cigarettes. Information gathered from this study may help understand how reduced nicotine in cigarettes may affect smokers, whether other nicotine products are used, and whether the characteristics, such as flavoring, of these other nicotine products makes a difference in cigarette smoking behavior in current smokers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06442384.
PRIMARY OBJECTIVE:
I. To assess the feasibility of our method to conduct a completely remote study involving the evaluation of tobacco product standards that can be imposed by the United States (U.S.) Food and Drug Administration.
SECONDARY OBJECTIVE:
I. To explore the effects of a reduced nicotine cigarette standard on smoking behavior in the context of flavor restrictions versus (vs.) no restrictions on e-cigarettes using a real world marketplace.
OUTLINE:
BASELINE PHASE: Participants continue to smoke preferred brand of cigarettes as usual for 2 weeks and attend 2 telehealth visits.
INTERVENTION PHASE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants purchase menthol or non-menthol VLN cigarettes plus tobacco flavored and non-tobacco flavored e-cigarettes, nicotine pouches or smokeless tobacco products using a provided debit card for 4 weeks. Participants may also purchase flavored or non-flavored nicotine gum or lozenge or nicotine patches. Participants also attend telehealth visits weekly for 4 weeks.
GROUP II: Participants purchase menthol or non-menthol VLN cigarettes plus tobacco flavored e-cigarettes, nicotine pouches, or smokeless tobacco products using a provided debit card for 4 weeks. Participants may also purchase flavored or non-flavored nicotine gum or lozenge or nicotine patches. Participants also attend telehealth visits weekly for 4 weeks.
After completion of study intervention, participants are followed up after 4 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorDorothy K. Hatsukami
