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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
64
Currently marketed unventilated cigarettes
Currently marketed ventilated cigarettes
University of Minnesota
Minneapolis, Minnesota, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Feasibility of approach - Drop outs
Percent of drop-outs in baseline and post-randomization.
Time frame: Baseline through Week 6
Feasibility of approach - Missing Data
Extent (percent) of missing data
Time frame: Baseline through Week 6
Feasibility of approach - Participant Satisfaction
Degree of difficulty collecting data through telehealth visits, mailing in biosamples and self-purchase of cigarettes (descriptive statistics (e.g., percent or mean responses)
Time frame: Baseline through Week 6
Change in Total Nicotine Equivalents (TNE)
The sum of nicotine and its metabolite concentrations used for evaluating nicotine exposure.
Time frame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
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.
Time frame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
Change in mean cigarettes per day (CPD)
The change in mean cigarettes per day (CPD) based on 7 day ITR data before visit 00 and week 6 visit.
Time frame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
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