COMET2 Project 1 Filter Ventilation Study

Phase 3

Completed

• Conditions: Smoking; Tobacco Use
• Interventions: Other: Unventilated cigarettes only; Other: Ventilated cigarettes only

• Registration Number: NCT03637972
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment.

Detailed 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 12 week experimental trial consisting of 2 weeks of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace, plus a follow-up visit 4 weeks after the intervention is over. 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 Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Study Start: 2018-10-18
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• At least 18 years of age
• Biochemically confirmed regular cigarette smoker

Exclusion Criteria

• Unstable health
• Unstable medications
• Pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Unventilated cigarettes only	Unventilated cigarettes only	Filters with approximately 3.0-4.6% filter ventilation
Ventilated cigarettes only	Ventilated cigarettes only	Filters with approximately 30-36% filter ventilation

Primary Outcome Measures

Name	Time	Method
The total NNAL at Week 8 Visit	Week 8	The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00)
Mean CPD based on 7 day IVR before week 8 visit.	Week 8	The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00.

Secondary Outcome Measures

Name	Time	Method
Number of cigarette-free days	Week 8	number of cigarette-free days based on no cigarettes smoked in the previous day on IVR (dropouts with no IVR data are assumed to be smoking)
Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline	Week 8	Absolute change from baseline in other biomarkers (e.g., TNE, NNN, mercapturic acids, PheT)

Trial Locations

Locations (2)

University of Minnesota Tobacco Research Program; 🇺🇸 Minneapolis, Minnesota, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States