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Filter Ventilation — COMET2P1  

Tobacco Use Clinical Trial

Official title:
Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Clinical Trial Summary

The goal of this study is to determine the biomarkers of exposure and harm as well as the pattern of product purchase when ventilated vs. unventilated cigarettes are available in the marketplace with and without alternative nicotine delivery systems (ANDS).

The primary aim of this study is to examine the effects of cigarette filter ventilation on biomarkers of toxicant exposure and toxicity and smoking behavior (cigs/day), with or without the availability of ANDS.

Clinical Trial Description

This randomized, open label, controlled multi-site study will simulate a "real world" tobacco environment by providing access to an experimental marketplace where they will be given vouchers that can be exchanged for assigned study cigarettes (either ventilated or unventilated) and two of the groups will also have access to non-combusted tobacco/nicotine products.

Subjects (N=550; N=125 in each group) will be randomly assigned to: 1) Ventilated cigarettes only; or 2) Unventilated cigarettes only; 3) Ventilated cigarettes + alternative nicotine delivery systems (ANDS); 4) Unventilated cigarettes + ANDS.

Smokers will undergo an in person screening and then a 10 week experimental trial with one week of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace. The experimental period will simulate a "real world" environment by providing participants with vouchers for a specified number of points that can be exchanged for study cigarettes and/or ANDS. At the end of the study they can exchange unspent points for money.

Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers), smoking topography and inhalation measures are taken at baseline and end of trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03715491
Study type Interventional
Source University of Minnesota - Clinical and Translational Science Institute
Contact Joni Jensen, MPH
Phone 612-6245178
Email jense010@umn.edu
Status Recruiting
Phase Phase 3
Start date October 25, 2018
Completion date September 30, 2022
View Details
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