Filter Ventilation for Tobacco Use

No longer recruiting at 1 trial location

Overseen By Dorothy K Hatsukami, PhD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different types of cigarette filters affect smokers. Researchers compare ventilated filters, which allow more air to mix with smoke, to unventilated filters, which do not. They aim to determine how these filters alter the exposure to harmful chemicals and influence smoking habits and perceptions. Regular smokers who smoke 5-30 cigarettes a day may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to understanding smoking behaviors and potentially improve public health.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes people with unstable medications. It's best to discuss your specific situation with the trial coordinators.

What prior data suggests that this method is safe for tobacco use?

Research has shown that ventilated cigarette filters are often believed to make smoking smoother and less irritating. However, they do not lower health risks. Many smokers think covering these vents makes cigarettes taste stronger, but this does not make them safer.

Studies on unventilated cigarette filters indicate that switching from filtered to unfiltered cigarettes does not increase harm risk. People who smoke unfiltered cigarettes are not exposed to higher levels of harmful substances compared to those who smoke filtered ones.

While opinions about these filters vary, no clear evidence suggests that one type is safer than the other regarding health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different levels of cigarette filter ventilation might impact tobacco use. Unlike traditional cigarettes, which don't focus on filter ventilation, the study compares ventilated filters (24-32% ventilation) with unventilated ones (0-5% ventilation). This could reveal how filter design influences smoking behavior and cravings, potentially leading to new strategies for reducing tobacco consumption. By understanding these effects, the trial might pave the way for innovative approaches to help people quit smoking or reduce their intake.

What evidence suggests that this trial's treatments could be effective for reducing toxicant exposure and smoking behavior?

This trial will compare ventilated cigarette filters with unventilated ones. Research has shown that filters with tiny holes, known as ventilated filters, can alter the intake of tar and nicotine. Studies have found that increased airflow through these filters reduces the tar and nicotine smokers receive from each cigarette. However, some people might mistakenly believe that ventilated cigarettes are safer, which isn't necessarily true. Regular filters without these holes don't significantly differ in harmful exposure compared to ventilated ones. It's important to understand that neither type of filter is proven to be much safer than regular cigarettes. ^{1 2 6 7 8}

Who Is on the Research Team?

Dorothy K Hatsukami, Ph.D

Principal Investigator

Masonic Cancer Center, University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7755531/

Effects of Unfiltered Cigarettes on Smoking Behavior and ... Data comparing the relative risks of smoking among age-matched cohorts of smokers across 50 years show that overall mortality, as well as the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352853224000257

Switching people who smoke to unfiltered cigarettes Conclusion. Lower average flow rates were associated with filtered cigarette smoking. No significant differences were found for other ST variables between ...

3. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/32/1/93

Smokers' awareness of filter ventilation, and how they believe ... This study explores current levels of awareness of filter ventilation and current understanding of its effects in these four countries.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218909/

Smokers Awareness and Risk Perceptions of Filter ... Approximately 40% of participants (mostly younger and male) reported awareness of the filter ventilation in their cigarettes. Only 30% of the ...

5. academic.oup.com academic.oup.com/ntr/article/27/8/1401/7901651

Opposition to Banning Cigarette Filters and the Belief That ... However, subsequent epidemiological data have shown that ventilated and unventilated filter-tip cigarettes were not less harmful than unfiltered ...

6. probiologists.com probiologists.com/article/filter-ventilation-and-the-risk-associated-with-cigarette-smoking

Filter ventilation and the risk associated with cigarette ... They concluded that filter ventilation appeared to be the main method for reducing yields, but also noted that some brands contain about twice as much nicotine ...

7. tobaccotactics.org tobaccotactics.org/article/cigarette-filters/

Cigarette Filters Filtered cigarettes have historically been marketed as safer than unfiltered. Evidence shows that they are not less harmful and have ...

8. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2024/10/21/tc-2024-058765

Nitrosamine and nicotine exposure after switching from filtered ... This proof-of-principle study suggests there is no increased risk to people who smoke when switching to unfiltered cigarette smoking.