Filter Ventilation for Tobacco Use

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment involving different types of cigarettes in reducing health risks?

Research suggests that smokers of lower tar filter cigarettes have reduced mortality rates for several cancers and chronic diseases compared to those who smoke higher tar plain cigarettes. However, the effectiveness of light and ultra-light cigarettes in significantly reducing health risks is questionable due to compensatory smoking behaviors. ^{1 2 3 4 5}

Is filter ventilation in cigarettes safe for humans?

Filter ventilation in cigarettes has been linked to an increase in lung adenocarcinomas (a type of lung cancer) and may lead to higher exposure to harmful smoke components. It can also create a false sense of safety, as 'light' cigarettes do not significantly reduce health risks compared to regular cigarettes. ^{1 3 5 6 7}

How does the treatment of using unventilated filter cigarettes differ from other treatments for tobacco use?

Unventilated filter cigarettes differ from other treatments for tobacco use by eliminating the filter ventilation that typically reduces tar and nicotine yields, potentially making cigarettes less appealing and encouraging smoking cessation. This approach contrasts with other treatments that focus on reducing nicotine intake or using alternative nicotine delivery systems. ^{3 4 5 8 9}

Research Team

Dorothy Hatsukami, PH.D

Principal Investigator

Masonic Cancer Center, University of Minnesota

Eligibility Criteria

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

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Mortality and type of cigarette smoked. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Maximum yields might improve public health--if filter vents were banned: a lesson from the history of vented filters. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cigarette filter ventilation is a defective design because of misleading taste, bigger puffs, and blocked vents. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Misuse of "light" cigarettes by means of vent blocking. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Cigarette Filter Ventilation and its Relationship to Increasing Rates of Lung Adenocarcinoma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prevalence of the misuse of ultra-low-tar cigarettes by blocking filter vents. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Switching to cigarette brand variants with different filter ventilation levels: a descriptive analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Smokers' awareness of filter ventilation, and how they believe it affects them: findings from the ITC Four Country Survey. [2023]