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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Ventilated non-menthol cigarettes; Other: Minimally Ventilated non-menthol cigarettes

Detailed Description

Smokers of cigarettes with about 16-30% ventilation in their conventional cigarettes who meet eligibility criteria will enter 3 weeks of monitoring of usual brand smoking. Subjects will then be randomly assigned for a period of 6 weeks to one of two conditions: 1) ventilated cigarettes; or 2) unventilated cigarettes. Subjects in each condition will be unblinded to simulate real world conditions. Subjects are provided with a debit card (ClinCard) that has been loaded with the appropriate amount of money to cover self-purchased usual brand cigarette in baseline and the assigned study cigarettes during intervention. Weekly telehealth visits will be conducted during baseline and the 6 weeks on study cigarettes to collect study measures, followed by a one month follow-up.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55405
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or females at least 21 years of age or older
• 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 <5 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).
• 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:
• Systolic BP greater than or equal to 160
• Diastolic BP greater than or equal to 100
• Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Heart rate greater than or equal to 105 bpm
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menthol Cigarette Smokers Group 1; 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.	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.
Active Comparator: Menthol Cigarettes Smokers Group 2; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants That Dropped Out	Percentage of Participants that dropped out by week 4.	Baseline through Week 4
Feasibility of Approach - Data Collection	Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and interview	Baseline through Week 4
Cigarettes Smoked Per Day	Change in mean Cigarettes Per Day (CPD) based on 7 day ITR data before visit. Randomized participants (low vs moderate FV), between-group difference in change in cigarettes per day from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cigarettes per day (CPD) was calculated as the mean number of cigarettes smoked per day based on daily self-reported cigarette use collected via interactive text response (ITR) surveys. Change scores were computed as the difference between the mean CPD at Week 4 and the mean CPD at baseline for each participant, and group differences reflect the between-arm difference in these change scores.	Baseline through Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cotinine Change	Change in cotinine from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in cotinine from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cotinine was measured from blood samples collected using volumetric absorptive micro sampling (VAMS) and analyzed using liquid chromatography-mass spectrometry. Due to skewness, cotinine values were log-transformed, and change was calculated as the log ratio of Week 4 to baseline levels. Group differences represent the between-arm difference in these log-transformed changes.	Baseline through week 4
Carbon Monoxide Changes	Change in Carbon Monoxide from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in carbon monoxide from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Exhaled carbon monoxide (ppm) was measured remotely using a portable CO monitor during scheduled study visits. Change scores were calculated as Week 4 minus baseline CO levels for each participant, and group differences represent the between-arm difference in these change scores.	Baseline through Week 4
Quit Attempts	Number of 24 hour quit attempts analyzed using regression estimate. Randomized participants (low vs moderate FV), between-group difference in quit attempt from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups.	Baseline through Week 4

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: Ohio State University
• Investigators: Principal Investigator: Dorothy Hatsukami, PH.D, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking
• Other Study ID Numbers: 2020LS110; 5P01CA217806 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No