Telehealth-Filter Ventilation ( COMET2P1 )

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Use

Treatments: Other: Unventilated Cigarette Filter; Other: Ventilated Cigarette Filter

Study type: Interventional

Funder types: Other

Identifiers

NCT04969783

P01CA217806 (U.S. NIH Grant/Contract)

2021LS034

P01CA217806-S2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Ventilated Cigarette Filter

Experimental group

Description:

Filters with approximately 24-32% filter ventilation

Treatment:

Other: Ventilated Cigarette Filter

Unventilated Cigarette Filter

Experimental group

Description:

Filters with approximately 0-5.0% filter ventilation

Treatment:

Other: Unventilated Cigarette Filter