Assessing the effects of different filter ventilation in cigarettes on smoking behavior
Feasibility of Conducting a Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
This study is testing how smoking either ventilated or unventilated cigarettes affects smokers' habits and health over a six-week period while using telehealth to check in with them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT04514471 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of conducting remote assessments of smoking behavior and tobacco exposure biomarkers using telehealth. Smokers of specific brands will undergo a 3-week monitoring period before being randomly assigned to smoke either ventilated or unventilated cigarettes for 6 weeks. Participants will engage in weekly telehealth visits to report on their smoking habits and provide biological samples, which will be collected at home and mailed to the study clinic. The study aims to simulate real-world conditions by allowing participants to purchase their usual brand cigarettes during the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who are regular smokers of eligible brands and in generally good health.
Not a fit: Patients with unstable health conditions, uncontrolled high blood pressure, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how cigarette filter ventilation affects smoking behavior and toxicant exposure, potentially informing smoking cessation strategies.
How similar studies have performed: While this approach is innovative in its use of telehealth for smoking behavior assessment, similar studies have shown promise in evaluating smoking interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 21 years of age or older * Regular cigarette smoker * Currently smoking an eligible brand * Generally good health * Access to smartphone or tablet and a device with a functioning camera for telehealth visits. Also must have internet access. Exclusion Criteria: * Unstable health * Uncontrolled high blood pressure * Pregnant or breast-feeding
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Dorothy Hatsukami, PH.D — Masonic Cancer Center, University of Minnesota
- Study coordinator: Joni Jensen, MPH
- Email: jense010@umn.edu
- Phone: 612-624-5178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.