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Completed

NCT Number: NCT03637972

COMET2 Project 1 Filter Ventilation Study

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.

Completed

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Key information

Conditions

Smoking Behavior Cigarette Smoking Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Minnesota Tobacco Research Program, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unstable health
  • Unstable medications
  • Pregnant or nursing

Treatment and study plan

Ventilated cigarettes only

Other

Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.

Unventilated cigarettes only

Other

Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.

Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems

Other

Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.

Access to Experimental Marketplace: Unventilated cigarettes + ANDS

Other

Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.

Primary outcomes

  1. The total NNAL at Week 8 Visit

    Time frame: 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.

    Time frame: 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 outcomes

  1. Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline

    Time frame: Week 8

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

  2. Number of cigarette-free days

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • Ohio State University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2018
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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