COMET2 Project 1 Filter Ventilation Study

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03637972
• Collaborator: Ohio State University (Other)
• Enrollment: 118
• Locations: 2
• Arms: 4
• Actual Duration (Months): 37.7
• Patients Per Site: 59
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking; Tobacco Use	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	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: Phase III randomized, open label, multi-center study assessing the impact of filter ventilation. Assigned to ventilated or unventilated cigarettes and either access to ANDS in an experimental marketplace, or no access to ANDS or any other products.Phase III randomized, open label, multi-center study assessing the impact of filter ventilation. Assigned to ventilated or unventilated cigarettes and either access to ANDS in an experimental marketplace, or no access to ANDS or any other products.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
• Actual Study Start Date: Oct 18, 2018
• Actual Primary Completion Date: Dec 9, 2021
• Actual Study Completion Date: Dec 9, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The total NNAL at Week 8 Visit [Week 8]

   The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00)

2. Mean CPD based on 7 day IVR before week 8 visit. [Week 8]

   The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00.

Secondary Outcome Measures

1. Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline [Week 8]

   Absolute change from baseline in other biomarkers (e.g., TNE, NNN, mercapturic acids, PheT)

2. Number of cigarette-free days [Week 8]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years of age

• Biochemically confirmed regular cigarette smoker

Exclusion Criteria:

• Unstable health

• Unstable medications

• Pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Tobacco Research Program	Minneapolis	Minnesota	United States	55414
2	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota
• Ohio State University

Investigators

• Principal Investigator: Dorothy K Hatsukami, Ph.D, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT03637972
• Other Study ID Numbers: 2018NTLS083; NCT03715491
• First Posted: Aug 20, 2018
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Nicotine

Study Results

No Results Posted as of Apr 29, 2022