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

Not Applicable

Recruiting

• Conditions: Smoking
• Interventions: Other: ventilated non-menthol cigarettes; Other: minimally ventilated non-menthol cigarettes

• Registration Number: NCT06439238
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Status Verified: 2024-05
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-31
• Last Update Submitted: 2024-05-31
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

• Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions.

• Unstable living environment that would compromise the ability to sequester study products or complete study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menthol cigarettes smokers group 1	ventilated non-menthol cigarettes	Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to ventilated non-menthol cigarettes
Menthol cigarettes smokers group 2	minimally ventilated non-menthol cigarettes	Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to minimally ventilated non-menthol cigarettes

Primary Outcome Measures

Name	Time	Method
feasibility-date collection	4 weeks	Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and Interview
feasibility- drop-out rate	4 weeks	Percent of drop-outs by 4 week visit

Secondary Outcome Measures

Name	Time	Method
Cigarettes smoked	baseline and week 4 visit	Change in mean cigarettes per day (CPD) based on 7 day ITR data before visit
carbon monoxide change	4 weeks	Change in carbon monoxide (CO) from baseline to the week 4 visit.
cotinine change	4 weeks	Change in cotinine from baseline to the week 4 visit.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States