Feasibility Study - Filter Ventilation

NCT04514471 | Completed

• 1 other identifier: 2020LS110
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (3)

• Feasibility of approach - Drop outs

  Percent of drop-outs in baseline and post-randomization.

  Baseline through Week 6

• Feasibility of approach - Missing Data

  Extent (percent) of missing data

  Baseline through Week 6

• Feasibility of approach - Participant Satisfaction

  Degree of difficulty collecting data through telehealth visits, mailing in biosamples and self-purchase of cigarettes (descriptive statistics (e.g., percent or mean responses)

  Baseline through Week 6

Secondary Outcomes (3)

• Change in Total Nicotine Equivalents (TNE)

  effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference

• Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)

  effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference

• Change in mean cigarettes per day (CPD)

  effect size for each arm calculated as the baseline minus the 6 week value divided by the SD of this difference

Study Arms (2)

Unventilated Filter Cigarette

EXPERIMENTAL

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

Other: Unventilated filter cigarettes

Ventilated Filter Cigarette

ACTIVE COMPARATOR

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

Other: Ventilated filter cigarettes

Interventions

Unventilated filter cigarettes OTHER

Currently marketed unventilated cigarettes

Unventilated Filter Cigarette

Ventilated filter cigarettes OTHER

Currently marketed ventilated cigarettes

Ventilated Filter Cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: collaborator
• Masonic Cancer Center, University of Minnesota: lead

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55405, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Dorothy Hatsukami, PH.D

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, between-subject, randomized multi-center pilot study

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: March 18, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 30, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (2)