Feasibility Study - Filter Ventilation

NCT ID: NCT04514471

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed 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.

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Unventilated Filter Cigarette

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

Group Type: EXPERIMENTAL

Unventilated filter cigarettes

Intervention Type: OTHER

Currently marketed unventilated cigarettes

Ventilated Filter Cigarette

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

Group Type: ACTIVE_COMPARATOR

Ventilated filter cigarettes

Intervention Type: OTHER

Currently marketed ventilated cigarettes

Interventions

Unventilated filter cigarettes

Currently marketed unventilated cigarettes

Intervention Type: OTHER

Ventilated filter cigarettes

Currently marketed ventilated cigarettes

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, PH.D

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2020LS110

Identifier Type: -

Identifier Source: org_study_id

NCT06439238

Identifier Type: -

Identifier Source: nct_alias