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Feasibility Study - Filter Ventilation

NCT04514471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-01-12

No results posted yet for this study

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

Interventions

OTHER

Unventilated filter cigarettes

Currently marketed unventilated cigarettes

OTHER

Ventilated filter cigarettes

Currently marketed ventilated cigarettes

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Dorothy Hatsukami, PH.D · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2025-06-05
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04514471 on ClinicalTrials.gov