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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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