RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-08

Study Completion:2025-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06439238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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: * 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.

Inclusion Criteria

Exclusion 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.

* 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:
* 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.

Contacts and Locations

Study Contact

Dana Carroll, PhD

CONTACT

(612) 624-0132

dcarroll@umn.edu

Principal Investigator

Dorothy Hatsukami, PhD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Dorothy Hatsukami, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08

Study Completion Date2025-03-15

Study Record Updates

Study Start Date2024-04-08

Study Completion Date2025-03-15

Terms related to this study

Additional Relevant MeSH Terms

Smoking