Telehealth-Filter Ventilation ( COMET2P1 )

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2024-03-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Single blind

Study Groups

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Ventilated Cigarette Filter

Filters with approximately 24-32% filter ventilation

Group Type EXPERIMENTAL

Ventilated Cigarette Filter

Intervention Type OTHER

Ventilated Cigarette Filter

Unventilated Cigarette Filter

Filters with approximately 0-5.0% filter ventilation

Group Type EXPERIMENTAL

Unventilated Cigarette Filter

Intervention Type OTHER

Unventilated Cigarette Filter

Interventions

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Ventilated Cigarette Filter

Intervention Type OTHER

Unventilated Cigarette Filter

Intervention Type OTHER

Eligibility Criteria

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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