Feasibility Study - Filter Ventilation
- Conditions
- Tobacco Use
- Interventions
- Other: Unventilated filter cigarettesOther: Ventilated filter cigarettes
- Registration Number
- NCT04514471
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Brief Summary
This open label, between-subject, randomized multi-center pilot study will assess the feasibility of conducting a study remotely with telehealth visits to assess the effect of cigarettes with minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of tobacco toxicant exposure. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per a day will be collected remotely. Biological samples will be collected at home and mailed to the study clinic.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- Unstable health
- Uncontrolled high blood pressure
- Pregnant or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unventilated Filter Cigarette Unventilated filter cigarettes Conventional cigarette with approximately 6-7% (non-menthol) and 5-6% filter ventilation (menthol). Ventilated Filter Cigarette Ventilated filter cigarettes Conventional cigarette with approximately 22-26% (non-menthol) and 35-38% filter ventilation (menthol).
- Primary Outcome Measures
Name Time Method Feasibility of approach - Drop outs Baseline through Week 6 Percent of drop-outs in baseline and post-randomization.
Feasibility of approach - Missing Data Baseline through Week 6 Extent (percent) of missing data
Feasibility of approach - Participant Satisfaction Baseline through Week 6 Degree of difficulty collecting data through telehealth visits, mailing in biosamples and self-purchase of cigarettes (descriptive statistics (e.g., percent or mean responses)
- Secondary Outcome Measures
Name Time Method Change in mean cigarettes per day (CPD) effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference The change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 6 visit.
Change in Total Nicotine Equivalents (TNE) effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference The sum of nicotine and its metabolite concentrations used for evaluating nicotine exposure.
Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference One of the tobacco specific nitrosamines, one of the most important groups of carcinogens in tobacco products, which are formed from nicotine during the curing and processing of tobacco.
Trial Locations
- Locations (2)
The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States