Telehealth-Filter Ventilation ( COMET2P1 )

Tobacco Use Clinical Trial

Official title:

Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04969783
• Other study ID #: 2021LS034
• Secondary ID: P01CA217806-S2P0
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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=184; N=92 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 with one week of baseline; 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 (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers) will be collected remotely and dropped off at the clinic.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: September 30, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• At least 21 years of age

• Biochemically confirmed regular cigarette smoker

Exclusion Criteria:

• Unstable health

• Unstable medications

• Pregnant or nursing

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Ventilated Cigarette Filter
Ventilated Cigarette Filter
• Unventilated Cigarette Filter
Unventilated Cigarette Filter

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	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 6 visit	6 weeks
Primary	Change in cigarettes per day (CPD)	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 week 6 visit using ITR (Interactive Text Response), daily diary reviewed data.	7 days prior to baseline visit and 7 days prior to week 6 visit