Clinical trial NCT04969783: Telehealth-Filter Ventilation ( COMET2P1 )
Official title: Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: cigarette smoking
filter ventilation
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2021-07-21
Enrollment: 164
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation
Primary purpose: BASIC_SCIENCE

Brief summary: The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette.

The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.

Detailed description: This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples.

Subjects (N=164; N=82 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes.

Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed.

Biomarker samples will be assessed for total nicotine equivalents, tobacco specific nitrosamines and volatile organic compound.

Eligibility criteria: Inclusion Criteria:

* At least 21 years of age
* Biochemically confirmed regular cigarette smoker
* Daily smoker, 5-30 cigarettes per day.
* Usual brand cigarettes 16-36% ventilation

Exclusion Criteria:

* Unstable health
* Unstable medications
* Pregnant or nursing

Primary outcomes:
measure: Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]
timeFrame: 6 weeks randomized intervention
measure: Change in Cigarettes Per Day (CPD)
timeFrame: 7 days prior to week 0 visit and 7 days prior to week 6 visit
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Tobacco Research Program
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Dorothy K Hatsukami, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: