COMET Study 1: Filter Ventilated Cigarette Substitution in the ETM

NCT03306173 | Completed Results

• 2 other identifiers: CigVent Proj-0031P01CA217806
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Early attempts by the tobacco industry to develop "safer" cigarettes led to the widespread introduction of ventilation holes in cigarette filters; however, this design feature may instead increase smoking-related harm and make cigarettes more palatable. The overall goal of this project is to model regulatory restrictions banning cigarette filter ventilation and determine their effects on consumption of both cigarettes and a wide range of alternative tobacco products. Testing potential regulatory actions under controlled conditions will facilitate evidence-based policies that have a net benefit to health.

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (8)

• High Ventilated Cigarette Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of their assigned cigarette increased progressively from $0.13 in the first trial to $4.00 in the final trial, while prices for other products (e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial were calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

• Low Ventilated Cigarette Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

• E-Cigarette Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial for ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

• E-liquid Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

• Gum Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

• Snus Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

• Lozenge Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

• Dip Purchases

  Participants completed purchasing trials in an experimental marketplace, a virtual store designed to mimic real-world shopping environments. In each lab session, participants completed multiple trials in which the price of High Ventilated Cigarettes (HVC) increased progressively from $0.13 in the first trial to $4.00 in the final trial foe ventilated cigarette users and Low Ventilated Cigarettes (LVC) increased progressively from $0.13 in the first trial to $4.00 for the unventilated group, while prices for other products (Low Ventilated Cigarettes (LVC), e-cigarettes, e-liquid, nicotine gum, snus, lozenges, and dip) remained constant. The mean and standard deviation of quantity purchased in each trial was calculated for all prices and sessions 1, 2, and 3.

  Week 2 (Session 1), Week 6 (Sessions 2), Week 10 (Session 3)

Study Arms (2)

Ventilated cigarettes

EXPERIMENTAL

Participants in this ARM will be assigned to \~25% filter ventilation commercially available cigarettes.

Other: Commercially available cigarette

Unventilated cigarettes

EXPERIMENTAL

Participants in this ARM will be assigned to \~0% filter ventilation commercially available cigarettes.

Other: Commercially available cigarette

Interventions

Commercially available cigarette OTHER

Commercially available cigarette with either \~0% or \~25% filter ventilation. Menthol flavor will be available in both types.

Unventilated cigarettes; Ventilated cigarettes

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current cigarette smoker
• Stable mental and physical health
• Does not take medications that interfere with nicotine metabolism

You may not qualify if:

• Pregnant or lactating
• Immediate future plans to quit smoking

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• University of Minnesota: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

During the study, the researchers detected changes in the ventilation levels of the low-ventilated study cigarettes introduced by the manufacturer, which may have altered the intended intervention and results.

Results Point of Contact

• Title: Dr. Roberta Freitas-Lemos
• Organization: Fralin Biomedical Research Institute at VTC

rflemos@vtc.vt.edu

540 526 2106

Study Officials

• Warren K Bickel, PHD

  Fralin Biomedical Research Institute at VTC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to either ventilated or unventilated cigarettes and will not be informed of their group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be assigned to either use a ventilated or unventilated cigarette.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 10, 2017
• Study Start: August 8, 2018
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: October 7, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon request after dissemination of results.
• Access Criteria: Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.

Locations

US (1)