Filter Ventilation

Tobacco Use Clinical Trial

— COMET2P1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715491
• Other study ID #: P01CA217806
• Status: Recruiting
• Phase: Phase 3
• Start date: October 25, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: Joni Jensen, MPH
• Phone: 612-6245178
• Email: jense010[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

• Tobacco Use

Intervention

Drug:
• Ventilated Cigarette Filter
Ventilated Cigarette Filter
• Unventilated Cigarette Filter
Unventilated Cigarette Filter
• Ventilated Cigarette Filter and ANDS
Ventilated Cigarette Filter and ANDS
• Unventilated Cigarette Filter and ANDS
Unventilated Cigarette Filter and 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
University of Minnesota - Clinical and Translational Science Institute	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total NNAL: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol	Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 8 visit.	8 weeks
Primary	Change in cigarettes per day	The absolute change from baseline for the mean CPD based on the mean CPD for 7 days prior to baseline visit 1 and 7 days prior to to week 8 visit using IVR reviewed data.	8 weeks on study product