COMET2 Project 1 Filter Ventilation Study

University of Minnesota (UMN)

Status and phase: Completed; Phase 3

Conditions: Smoking; Tobacco Use

Treatments: Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDS; Other: Unventilated cigarettes only; Other: Ventilated cigarettes only; Other: Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems

Study type: Interventional

Funder types: Other

Identifiers

NCT03637972

2018NTLS083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Unstable health
• Unstable medications
• Pregnant or nursing

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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118 participants in 4 patient groups

Ventilated cigarettes only

Experimental group

Description:

Filters with approximately 30-36% filter ventilation

Treatment:

Other: Ventilated cigarettes only

Unventilated cigarettes only

Experimental group

Description:

Filters with approximately 3.0-4.6% filter ventilation

Treatment:

Other: Unventilated cigarettes only

Ventilated cigarettes + alternative nicotine delivery systems

Experimental group

Description:

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).

Treatment:

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

Unventilated cigarettes + ANDS

Experimental group

Description:

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).

Treatment:

Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDS