Clinical trial NCT04514471: Feasibility Study - Filter Ventilation
Official title: Feasibility of Conducting a Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: National Cancer Institute (NCI)
First posted: 2020-08-17
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, between-subject, randomized multi-center pilot study
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of approach - Drop outs
timeFrame: Baseline through Week 6
measure: Feasibility of approach - Missing Data
timeFrame: Baseline through Week 6
measure: Feasibility of approach - Participant Satisfaction
timeFrame: Baseline through Week 6
Secondary outcomes:
measure: Change in Total Nicotine Equivalents (TNE)
timeFrame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
measure: Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
timeFrame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
measure: Change in mean cigarettes per day (CPD)
timeFrame: effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Dorothy Hatsukami, PH.D
role: PRINCIPAL_INVESTIGATOR
References: