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Telehealth-Filter Ventilation ( COMET2P1 )

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04969783
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : March 21, 2022
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Tobacco Use Other: Ventilated Cigarette Filter Other: Unventilated Cigarette Filter Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation
Masking: Single (Participant)
Masking Description: Single blind
Primary Purpose: Basic Science
Official Title: Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : September 30, 2024
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 21 years of age
  • Biochemically confirmed regular cigarette smoker

Exclusion Criteria:

  • Unstable health
  • Unstable medications
  • Pregnant or nursing
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Joni Jensen, MPH 612-624-5178 jense010@umn.edu
Contact: Lori Strayer, MPH 612-626-5189 strayer@umn.edu

Locations
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United States, Minnesota
University of Minnesota Tobacco Research Program Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Joni A Jensen    612-624-5178    jense010@umn.edu   
Principal Investigator: Dorothy K Hatsukami, PhD         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sarah Reisinger, MPH, MCHES    614-366-4542    Sarah.Reisinger@osumc.edu   
Contact: Peter Shields, MD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Ohio State University
Investigators
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Principal Investigator: Dorothy K Hatsukami, Ph.D Masonic Cancer Center, University of Minnesota
More Information
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT04969783    
Other Study ID Numbers: P01CA217806-S2
P01CA217806 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will not be available until primary and secondary papers are accepted for publication
Access Criteria: Persons requesting data must do so in writing, identifying their affiliation and how the data will be used. Upon review, access will be determined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Masonic Cancer Center, University of Minnesota:
cigarette smoking
filter ventilation