COMET2 Project 1 Filter Ventilation Study

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

Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Use
• Intervention / Treatment: Other: Ventilated cigarettes only; Other: Unventilated cigarettes only; Other: Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems; Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDS

Detailed 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 12 week experimental trial consisting of 2 weeks of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace, plus a follow-up visit 4 weeks after the intervention is over. 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota Tobacco Research Program
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years of age
• Biochemically confirmed regular cigarette smoker

Exclusion Criteria:

• Unstable health
• Unstable medications
• Pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventilated cigarettes only; Filters with approximately 30-36% filter ventilation	Other: Ventilated cigarettes only; Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
Experimental: Unventilated cigarettes only; Filters with approximately 3.0-4.6% filter ventilation	Other: Unventilated cigarettes only; Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
Experimental: Ventilated cigarettes + alternative nicotine delivery systems; Filters with approximately 30-36% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch).	Other: Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems; Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
Experimental: Unventilated cigarettes + ANDS; Filters with approximately 3.0-4.6% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch).	Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDS; Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total NNAL at Week 8 Visit	The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00)	Week 8
Mean CPD based on 7 day IVR before week 8 visit.	The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline	Absolute change from baseline in other biomarkers (e.g., TNE, NNN, mercapturic acids, PheT)	Week 8
Number of cigarette-free days	number of cigarette-free days based on no cigarettes smoked in the previous day on IVR (dropouts with no IVR data are assumed to be smoking)	Week 8

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: Ohio State University
• Investigators: Principal Investigator: Dorothy K Hatsukami, Ph.D, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cigarette smoking; Filter Ventilation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2018NTLS083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 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.
• IPD Sharing Time Frame: Data will not be available until primary and secondary papers are accepted for publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No