Filter Ventilation for Tobacco Use

No longer recruiting at 1 trial location

Overseen By Lori Strayer, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Disqualifiers: Unstable health, Uncontrolled high blood pressure, Pregnant, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of cigarette filters might affect smoking habits and exposure to harmful substances. Researchers compare unventilated filter cigarettes (with less ventilation) to ventilated filter cigarettes (with more ventilation) to determine any changes in smoking behavior or health markers. They will collect data on daily cigarette consumption and carbon monoxide levels, all remotely via telehealth. Ideal participants are regular smokers in generally good health who have access to a smartphone or tablet for remote check-ins. As an unphased trial, this study offers the chance to contribute to important research that could influence future smoking cessation strategies.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past research found that switching to unventilated filter cigarettes did not increase risk for smokers, indicating these cigarettes do not worsen health risks. For ventilated filter cigarettes, studies have not clearly linked ventilation levels to a higher risk of smoking-related diseases. The holes in these filters allow air to mix with smoke, potentially altering perceptions of risk without necessarily increasing them. Overall, neither type of cigarette appears to increase health risks beyond those of regular smoking. However, smoking itself is known to be harmful to health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for filter ventilation in tobacco use because it explores how different levels of ventilation in cigarette filters might impact smoking behavior and health risks. Most conventional cigarettes have a fixed level of filter ventilation, but this trial compares unventilated filters with high-ventilation filters to see if they change the way people smoke or affect exposure to harmful substances. The unventilated filters have minimal ventilation, while the ventilated filters allow for more air, potentially diluting harmful smoke components. This could lead to insights on reducing smoking-related harm, which is a fresh angle compared to standard cessation aids like nicotine patches or gum.

What evidence suggests that this trial's treatments could be effective for tobacco use?

This trial will compare unventilated filter cigarettes with ventilated filter cigarettes. Research has shown that cigarettes with unventilated filters expose smokers to more nicotine and tar due to less air mixing with the smoke. In contrast, ventilated filter cigarettes allow more air to mix in, potentially reducing nicotine and tar levels. However, smokers might mistakenly believe that ventilated cigarettes are safer, which isn't necessarily true. Although ventilated filters might lower some exposure, they do not eliminate the risks of smoking. ^{6 7 8 9 10}

Who Is on the Research Team?

Dorothy Hatsukami, PH.D

Principal Investigator

Masonic Cancer Center, University of Minnesota

Are You a Good Fit for This Trial?

This trial is for people over 21 who regularly smoke cigarettes of an eligible brand, are in good health overall, and have access to a smartphone or tablet with a camera and internet for telehealth visits.

Inclusion Criteria

Generally good health

Access to smartphone or tablet and a device with a functioning camera for telehealth visits. Also must have internet access.

I am currently smoking a brand that is part of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

Participants undergo 3 weeks of monitoring of usual brand smoking

3 weeks

3 visits (virtual)

Treatment

Participants are randomly assigned to smoke either ventilated or unventilated cigarettes for 6 weeks

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Unventilated filter cigarettes
• Ventilated filter cigarettes

Trial Overview The study compares the effects of smoking cigarettes with minimal filter ventilation versus moderate filter ventilation on smoking habits and exposure to tobacco toxins. Participants will use telehealth services and send biological samples by mail.

How Is the Trial Designed?

Group I: Unventilated Filter Cigarette Experimental Treatment 1 Intervention

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

Group II: Ventilated Filter Cigarette Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

A study of 158 discarded light cigarette butts revealed that 47% showed extreme blocking of filter vents, which can lead to higher tar and nicotine exposure than intended.

The findings suggest that smokers may not be aware of the risks associated with vent blocking in light cigarettes, highlighting the need for better consumer education regarding the health implications of smoking these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Misuse of "light" cigarettes by means of vent blocking. Kozlowski, LT., Pillitteri, JL., Sweeney, CT.[2019]

Smokers in the UK have shifted from high tar plain cigarettes to lower tar filter cigarettes, resulting in a significant reduction in average tar yields by about half, which is associated with lower mortality rates for various cancers and chronic diseases.

Epidemiological evidence suggests that smokers of lower tar filter cigarettes experience reduced mortality from lung cancer, chronic bronchitis, and other conditions compared to those who smoke higher tar cigarettes, although more research is needed to fully understand the long-term effects of low tar cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality and type of cigarette smoked. Lee, PN., Garfinkel, L.[2023]

The introduction of filter and light cigarettes has led to a modest reduction in lung cancer risk (20-40%), but smoking light cigarettes does not significantly lower the risk of lung cancer or other serious health issues due to compensatory smoking behaviors.

Promoting light and ultra-light cigarettes as safer alternatives is misleading, as there is no substantial clinical evidence supporting their efficacy in reducing health risks, and such marketing may encourage continued smoking rather than cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Do light cigarettes decrease the risk of smoking?]. Klech, H.[2015]

In a study analyzing 135 discarded cigarette filters from public areas, it was found that 19% were extremely blocked and 39% were partially blocked, indicating a significant prevalence of blocked air dilution vents in ultra-low-yield cigarettes.

The findings highlight a potential health risk for smokers, as vent blocking can lead to increased inhalation of harmful substances, emphasizing the need for awareness among smokers, health practitioners, and researchers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of the misuse of ultra-low-tar cigarettes by blocking filter vents. Kozlowski, LT., Pope, MA., Lux, JE.[2023]

Filter ventilation in modern cigarettes significantly influences the levels of tar, nicotine, and carbon monoxide, making it a key design feature for low tar cigarettes.

Banning filter vents while also setting low maximum limits for tar, nicotine, and carbon monoxide could make cigarettes less appealing and encourage smokers to quit or switch to safer nicotine delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximum yields might improve public health--if filter vents were banned: a lesson from the history of vented filters. Kozlowski, LT., O'Connor, RJ., Giovino, GA., et al.[2023]

Only 40.3% of smokers surveyed were aware of filter ventilation in their cigarettes, and among daily smokers, just 9.4% believed their cigarettes had this feature, indicating a significant gap in awareness despite its prevalence.

Smokers who thought their cigarettes were smoother or less harmful were more likely to believe they had filter ventilation, suggesting that this technology misleads smokers about the safety and experience of smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smokers' awareness of filter ventilation, and how they believe it affects them: findings from the ITC Four Country Survey. King, B., Borland, R., Le Grande, M., et al.[2023]

Switching to a cigarette brand variant (CBV) with lower filter ventilation (FV) does not seem to increase smoking exposure, and may even lead to reduced exposure to harmful substances for some smokers, as indicated by a significant reduction in total nicotine equivalents (TNE) when FV decreased.

The study, which analyzed data from 371 daily smokers over a period from 2013 to 2017, found non-significant trends in changes in cigarettes per day (CPD) based on FV adjustments, suggesting that further research is needed to confirm these initial findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching to cigarette brand variants with different filter ventilation levels: a descriptive analysis. Carroll, DM., Tessier, K., Luo, X., et al.[2023]

Filter ventilation in cigarettes creates a misleading perception of safety by making them taste lighter and milder, which can lead smokers to underestimate their risks.

This design feature also encourages compensatory smoking behaviors, such as taking larger puffs or blocking vents, which can result in higher smoke yields than expected, making lower tar cigarettes potentially more dangerous.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette filter ventilation is a defective design because of misleading taste, bigger puffs, and blocked vents. Kozlowski, LT., O'Connor, RJ.[2022]

The 2014 Surgeon General's Report linked changes in cigarette designs, particularly filter ventilation, to an increase in lung adenocarcinomas, suggesting that these design changes may have made smoking more harmful rather than safer.

Filter ventilation alters tobacco combustion and allows smokers to inhale more toxic smoke while creating a false sense of safety, which may contribute to the rising rates of lung adenocarcinomas, indicating a need for FDA regulation or a potential ban on this feature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette Filter Ventilation and its Relationship to Increasing Rates of Lung Adenocarcinoma. Song, MA., Benowitz, NL., Berman, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6059254/

Cigarette Filter Ventilation and its Relationship to Increasing ... The analysis strongly suggests that filter ventilation has contributed to the rise in lung adenocarcinomas among smokers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12489821/

Cross-sectional findings from the 2019 ITC France Survey Cigarettes reported by male respondents tended on average to have lower closed pressure drop (87.6 mmWG vs 100.7 mmWG, p<0.001), ventilation ( ...

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

Smokers' awareness of filter ventilation, and how they believe ... Overall, 50.4% of exclusive daily FMC smokers believe their usual cigarettes are smoother. This was more likely among those believing their usual cigarette has ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06439238

NCT06439238 | Feasibility Study - Filter Ventilation Smokers of cigarettes with about 16-30% ventilation in their conventional cigarettes who meet eligibility criteria will enter 3 weeks of monitoring of usual ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0273230017303434

Influence of cigarette filter ventilation on smokers' mouth ... The objective of this study was to investigate the relationship between cigarette filter ventilation and mouth level exposure (MLE) to tar and nicotine in ...

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

Effects of Unfiltered Cigarettes on Smoking Behavior and ... We have designed an open-label, randomized, 9-week, crossover clinical trial of adult filtered-cigarette smokers who switch to unfiltered cigarettes.

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

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

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

Filter ventilation and the risk associated with cigarette ... There appears to be no good epidemiological evidence relating risk of smoking-related diseases in smokers of filtered cigarettes specifically to the degree of ...

9. 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.

10. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Illusion-of-filtration-Evidence-from-tobacco-industry-ndocuments,166093,0,2.html

Illusion of filtration: Evidence from tobacco industry ... Results: In all years, filtered cigarettes had less tobacco by weight compared to nonfiltered cigarettes. The lower average weight of tobacco ...