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: Recruiting
• Conditions: Smoking
• Intervention / Treatment: Other: ventilated non-menthol cigarettes; Other: minimally ventilated non-menthol cigarettes

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Carroll, PhD; Phone Number: (612) 624-0132; Email: dcarroll@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Dana Carroll; Email: dcarroll@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menthol cigarettes 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; a 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.
Experimental: 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; a 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
feasibility- drop-out rate	Percent of drop-outs by 4 week visit	4 weeks
feasibility-date collection	Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and Interview	4 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
quit attempts	Number of 24 hour quit attempts.	10 weeks
Mean of the Fagerström Test for Nicotine Dependence (FTND)	This is a 7-question test that assesses physical nicotine dependence. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.	4 weeks
Mean of the subscales of the modified Cigarette Evaluation Questionnaire (mCEQ)	It measures self-reported, subjective reinforcing and aversive effects of smoking. It contains 19 questions and answers vary from 1(not at all) to 7 (extremely). The higher the score, the greater the reinforcement of cigarette behavior.	4 weeks
Perceived health risks	assesses perceived health risks of tobacco use, study brand of cigarettes. This scale involves rating the extent of perceived risk of a product for different lung cancer. It involves rating perceived disease risk on a 1-10 visual analogue scale with 1 anchored at very low risk for disease and 10 anchored at very high risk.	4 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Dorothy Hatsukami, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: #2020LS110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No