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Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes
Sponsor: Masonic Cancer Center, University of Minnesota
Summary
This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g. nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-03-18
Completion Date
2025-06-30
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
Minimally Ventilated non-menthol cigarettes
4 week intervention where participants will be using minimally ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.
Ventilated non-menthol cigarettes
4 week intervention where participants will be using ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.
Locations (1)
University of Minnesota
Minneapolis, Minnesota, United States