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COMPLETED
NCT04514471
NA

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

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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