Filter Ventilation for Tobacco Use

Recruiting at 1 trial location

Overseen By Joni Jensen, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Disqualifiers: Unstable health, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

164 Participants Needed

Trial Summary

What is the purpose of this trial?

The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette. The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.

Research Team

Dorothy K Hatsukami, Ph.D

Principal Investigator

Masonic Cancer Center, University of Minnesota

Eligibility Criteria

This trial is for regular cigarette smokers who are at least 21 years old and have their smoking status confirmed biochemically. It's not suitable for individuals with unstable health conditions, those on fluctuating medications, or pregnant or nursing women.

Inclusion Criteria

I am at least 21 years old.

Biochemically confirmed regular cigarette smoker

Exclusion Criteria

You are pregnant or breastfeeding.

My medications have been stable for the last month.

Your health is not stable or consistent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Participants smoke their usual brand cigarettes to establish baseline measures

1 week

Remote monitoring

Treatment

Participants are assigned to smoke either ventilated or unventilated study cigarettes

8 weeks

Remote monitoring, biological samples collected at home

Follow-up

Participants are monitored for changes in smoking behavior and biomarkers after treatment

4 weeks

Treatment Details

Interventions

• Unventilated Cigarette Filter
• Ventilated Cigarette Filter

Trial Overview The study is testing the effects of cigarettes with ventilated filters versus unventilated filters on toxicant exposure and smoking behavior. Participants will be monitored for changes in urinary biomarkers and their responses to the cigarettes.

Participant Groups

Group I: Ventilated Cigarette Filter Experimental Treatment 1 Intervention

Filters with approximately 24-32% filter ventilation

Group II: Unventilated Cigarette Filter Experimental Treatment 1 Intervention

Filters with approximately 0-5.0% filter ventilation

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+