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

University of Minnesota1 site in 1 country60 target enrollmentApril 8, 2024

ConditionsSmoking

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Smoking
Sponsor: University of Minnesota
Enrollment: 60
Locations: 1
Primary Endpoint: feasibility-date collection
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 8, 2024

End Date

March 15, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or females at least 21 years of age.
•Smoking menthol cigarettes most of the time (80% of cigarette purchases).
•Self-report of daily smoking of at least 5 - 25 cigarettes for \>= 3 months by self-report.
•Carbon monoxide indicative of regular smoking (CO \> 6ppm) prior to randomization.
•Has regular access to a smartphone or tablet for use with CO device and smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys.

Exclusion Criteria

•Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free \<= years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 30 days or as determined by the licensed medical professional at each site).
•Purchased alternative nicotine products within the last month
•Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional at each site).
•Excessive drinking or problems with drinking or drugs (assessed by PI or licensed medical professional).
•Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy.
•Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact biomarkers or patient safety to be determined by the licensed medical professional).
•Vital signs outside of the following range:
•i. Systolic BP greater than or equal to 160 ii. Diastolic BP greater than or equal to 100 iii. Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) iv. Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) v. Heart rate greater than or equal to 105 bpm vi. Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) (Participants failing for heart rate or blood pressure will be allowed to re-screen once).
•Household member enrolled in the study concurrently.
•Participated in prior research study during the past three months that would impact baseline smoking or response to study products.