COMET2 Project 1 Filter Ventilation Study

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637972
• Other study ID #: 2018NTLS083
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2018
• Est. completion date: December 9, 2021

Study information

• Verified date: April 2022
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03715491

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Biochemically confirmed regular cigarette smoker

Exclusion Criteria:

• Unstable health

• Unstable medications

• Pregnant or nursing

Related Conditions & MeSH terms

• Smoking
• Tobacco Use

Intervention

Other:
• Ventilated cigarettes only
Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
• Unventilated cigarettes only
Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
• Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems
Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
• Access to Experimental Marketplace: Unventilated cigarettes + ANDS
Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	University of Minnesota Tobacco Research Program	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total NNAL at Week 8 Visit	The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00)	Week 8
Primary	Mean CPD based on 7 day IVR before week 8 visit.	The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00.	Week 8
Secondary	Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline	Absolute change from baseline in other biomarkers (e.g., TNE, NNN, mercapturic acids, PheT)	Week 8
Secondary	Number of cigarette-free days	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)	Week 8