Feasibility Study - Filter Ventilation

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Use

Treatments: Other: Unventilated filter cigarettes; Other: Ventilated filter cigarettes

Study type: Interventional

Funder types: Other

Identifiers

NCT04514471

2020LS110

Details and patient eligibility

About

This open label, between-subject, randomized multi-center pilot study will assess the feasibility of conducting a study remotely with telehealth visits to assess the effect of cigarettes with minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of tobacco toxicant exposure. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per a day will be collected remotely. Biological samples will be collected at home and mailed to the study clinic.

Full description

Smokers of cigarettes with about 16-30% ventilation in their conventional cigarettes who meet eligibility criteria will enter 3 weeks of monitoring of usual brand smoking. Subjects will then be randomly assigned for a period of 6 weeks to one of two conditions: 1) ventilated cigarettes; or 2) unventilated cigarettes. Subjects in each condition will be unblinded to simulate real world conditions. Subjects are provided with a debit card (ClinCard) that has been loaded with the appropriate amount of money to cover self-purchased usual brand cigarette in baseline and the assigned study cigarettes during intervention. Weekly telehealth visits will be conducted during baseline and the 6 weeks on study cigarettes to collect study measures, followed by a one month follow-up.

Enrollment: 64 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 21 years of age or older
• Regular cigarette smoker
• Currently smoking an eligible brand
• Generally good health
• Access to smartphone or tablet and a device with a functioning camera for telehealth visits. Also must have internet access.

Exclusion criteria

• Unstable health
• Uncontrolled high blood pressure
• Pregnant or breast-feeding

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Unventilated Filter Cigarette

Experimental group

Description:

Conventional cigarette with approximately 6-7% (non-menthol) and 5-6% filter ventilation (menthol).

Treatment:

Other: Unventilated filter cigarettes

Ventilated Filter Cigarette

Active Comparator group

Description:

Conventional cigarette with approximately 22-26% (non-menthol) and 35-38% filter ventilation (menthol).

Treatment:

Other: Ventilated filter cigarettes