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

NCT04514471 | Completed Results

• 1 other identifier: 2020LS110
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Cotinine Change

  Baseline through week 4

• Carbon Monoxide Changes

  Baseline through Week 4

• Quit Attempts

  Baseline through Week 4

Study Arms (2)

Menthol Cigarette Smokers Group 1

EXPERIMENTAL

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

Menthol Cigarettes Smokers Group 2

ACTIVE COMPARATOR

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

Interventions

Ventilated non-menthol cigarettes OTHER

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.

Menthol Cigarette Smokers Group 1

Minimally Ventilated non-menthol cigarettes OTHER

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.

Menthol Cigarettes Smokers Group 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55405, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dana Carroll, PhD
• Organization: Masonic Cancer Center

dcarroll@umn.edu

612-624-4998

Study Officials

• Dorothy Hatsukami, PH.D

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, between-subject, randomized multi-center pilot study

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: March 18, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 30, 2025
• Last Updated: September 9, 2026
• Results First Posted: September 9, 2026

Record last verified: 2026-09

Locations

US (1)