Clinical trial NCT03637972: COMET2 Project 1 Filter Ventilation Study
Official title: Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Tobacco Use
Keywords: Cigarette smoking
Filter Ventilation
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2018-08-20
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unstable health
* Unstable medications
* Pregnant or nursing

Primary outcomes:
measure: The total NNAL at Week 8 Visit
timeFrame: Week 8
measure: Mean CPD based on 7 day IVR before week 8 visit.
timeFrame: Week 8
Secondary outcomes:
measure: Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline
timeFrame: Week 8
measure: Number of cigarette-free days
timeFrame: Week 8
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Tobacco Research Program
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University of Minnesota
name: Dorothy K Hatsukami, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: