Telehealth-Filter Ventilation ( COMET2P1 )
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|ClinicalTrials.gov Identifier: NCT04969783|
Recruitment Status : Not yet recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use||Other: Ventilated Cigarette Filter Other: Unventilated Cigarette Filter||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation|
|Masking Description:||Single blind|
|Primary Purpose:||Basic Science|
|Official Title:||Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers|
|Estimated Study Start Date :||June 1, 2022|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Ventilated Cigarette Filter
Filters with approximately 24-32% filter ventilation
Other: Ventilated Cigarette Filter
Ventilated Cigarette Filter
Experimental: Unventilated Cigarette Filter
Filters with approximately 0-5.0% filter ventilation
Other: Unventilated Cigarette Filter
Unventilated Cigarette Filter
- Change in Total NNAL: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [ Time Frame: 6 weeks ]Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit
- Change in cigarettes per day (CPD) [ Time Frame: 7 days prior to baseline visit and 7 days prior to week 6 visit ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969783
|Contact: Joni Jensen, MPHfirstname.lastname@example.org|
|Contact: Lori Strayer, MPHemail@example.com|
|United States, Minnesota|
|University of Minnesota Tobacco Research Program|
|Minneapolis, Minnesota, United States, 55414|
|Contact: Joni A Jensen 612-624-5178 firstname.lastname@example.org|
|Principal Investigator: Dorothy K Hatsukami, PhD|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Contact: Sarah Reisinger, MPH, MCHES 614-366-4542 Sarah.Reisinger@osumc.edu|
|Contact: Peter Shields, MD|
|Principal Investigator:||Dorothy K Hatsukami, Ph.D||Masonic Cancer Center, University of Minnesota|