Filter Ventilation Changes for Smokers

Overseen By Dana Carroll, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Exclusionary medications

Disqualifiers: Cardiovascular disease, COPD, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those on unstable medication doses or with conditions that could affect safety or study results. It's best to discuss your specific medications with the trial's medical professional.

What data supports the effectiveness of the treatment Minimally Ventilated Non-Menthol Cigarettes, Minimally Ventilated Non-Menthol Cigarettes, Ventilated Non-Menthol Cigarettes, Non-Menthol Cigarettes with Filter Ventilation?

The research suggests that filter ventilation in cigarettes can change how people smoke, which might affect their experience and satisfaction. However, there is no direct evidence from the provided studies that these changes lead to improved health outcomes or effectiveness in reducing smoking-related harm. ^{1 2 3 4 5}

Is it safe to use cigarettes with different filter ventilation levels?

The research does not provide specific safety information about cigarettes with different filter ventilation levels, but it does suggest that menthol cigarettes, which are similar in some ways, do not increase the risk of lung cancer or other health issues compared to non-menthol cigarettes. However, smoking any type of cigarette is generally harmful to health. ^{3 4 5 6 7}

How is the treatment of minimally ventilated non-menthol cigarettes different from other smoking treatments?

This treatment involves using cigarettes with minimal filter ventilation, which can alter smoking behavior and sensations compared to regular ventilated cigarettes. The unique aspect is the reduced filter ventilation, which may lead to different smoking patterns and subjective experiences, potentially affecting nicotine intake and health perceptions. ^{1 8 9 10 11}

What is the purpose of this trial?

This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g., nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.

Research Team

Dorothy Hatsukami, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for menthol cigarette smokers who are interested in switching to non-menthol cigarettes. Participants will need the ability to conduct telehealth visits and send samples by mail.

Inclusion Criteria

Carbon monoxide indicative of regular smoking (CO > 6ppm) prior to randomization

Smoking menthol cigarettes most of the time (80% of cigarette purchases)

Has regular access to a smartphone or tablet for use with CO device and smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys

Exclusion Criteria

Purchased alternative nicotine products within the last month

Excessive drinking or problems with drinking or drugs (assessed by PI or licensed medical professional)

Vital signs outside of specified ranges for blood pressure and heart rate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Remote eligibility assessment

Monitoring

Participants undergo 2 weeks of monitoring of usual brand smoking

2 weeks

Remote monitoring

Treatment

Participants are randomized to ventilated or minimally ventilated non-menthol cigarettes

4 weeks

Telehealth visits and mailed samples

Follow-up

Participants are monitored for changes in smoking behavior and biomarkers

4 weeks

Remote data collection

Treatment Details

Interventions

• Minimally Ventilated Non-Menthol Cigarettes
• Ventilated Non-Menthol Cigarettes

Trial Overview The study is testing how changing from menthol to non-menthol cigarettes with different filter ventilation affects smoking behavior and exposure to harmful substances, using remote monitoring and sample collection.

Participant Groups

Group I: Menthol cigarettes smokers group 2 Experimental Treatment 1 Intervention

Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to minimally ventilated non-menthol cigarettes

Group II: Menthol cigarettes smokers group 1 Experimental Treatment 1 Intervention

Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to ventilated non-menthol cigarettes

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

In a study involving 607 participants, it was found that the way smokers puff on cigarettes (topography) mediates the relationship between filter ventilation and their satisfaction and enjoyment from smoking.

Younger smokers (under 43 years) and those who smoke fewer than 15 cigarettes a day showed stronger connections between puff count and enjoyment, suggesting that filter ventilation could influence how different groups perceive their smoking experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette filter ventilation, smoking topography, and subjective effects: A mediational analysis. Diaz, D., Luo, X., Hatsukami, DK., et al.[2022]

In a study of 5699 current smokers, menthol cigarette use was not associated with a lower risk of COPD or major CT findings, indicating that menthol cigarettes do not offer any safety advantage over non-menthol cigarettes.

However, menthol cigarette smokers were found to have a higher likelihood of experiencing severe COPD exacerbations, with an odds ratio of 1.29, suggesting that menthol cigarettes may lead to worse outcomes in COPD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menthol cigarette smoking in the COPDGene cohort: relationship with COPD, comorbidities and CT metrics. Park, SJ., Foreman, MG., Demeo, DL., et al.[2023]

Menthol in cigarettes is a biologically active compound that may influence health effects, but the specific impacts compared to non-menthol cigarettes are not well understood due to limited research.

The review highlights that while menthol affects various health aspects such as toxicity, lung function, and inflammation, many findings are inconclusive, making it difficult to draw definitive conclusions about its overall health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The health effects of menthol cigarettes as compared to non-menthol cigarettes. Hoffman, AC.[2021]

Five large epidemiological studies found no evidence that smoking mentholated cigarettes increases the risk of lung cancer, even among African-American male smokers who predominantly use menthols.

Mentholation does not significantly affect smoking behavior or health metrics such as puff volume, heart rate, or nicotine absorption, suggesting that its toxicological effects on adult smokers are likely minimal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible effects on smokers of cigarette mentholation: a review of the evidence relating to key research questions. Werley, MS., Coggins, CR., Lee, PN.[2022]

Menthol cigarettes are particularly popular among younger smokers, with 56.7% of 12-17 year olds and 45.0% of 18-25 year olds using them, compared to lower rates in older age groups.

While overall smoking rates for non-menthol cigarettes decreased among adolescents and young adults from 2004 to 2010, menthol cigarette use remained constant or even increased, indicating that mentholated cigarettes may hinder efforts to reduce youth smoking rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential trends in cigarette smoking in the USA: is menthol slowing progress? Giovino, GA., Villanti, AC., Mowery, PD., et al.[2022]

Studies comparing menthol and nonmenthol cigarettes have shown inconsistent results regarding their toxicity, leading manufacturers to claim that menthol does not increase harm.

The authors argue that focusing solely on toxicity is too limited and does not adequately address the broader public health concerns associated with menthol cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menthol should not be given a free pass based on studies of biomarkers of toxicity. Clark, PI., Gardiner, P.[2018]

A study using data from the 2005 New Jersey Adult Tobacco Survey found that only a small percentage of menthol smokers (2.4%) believed menthol cigarettes to be less risky than nonmenthol cigarettes, indicating a general awareness of potential risks.

Interestingly, a significant portion of respondents, including 30.2% of menthol smokers, perceived menthol cigarettes as more risky than nonmenthols, with higher awareness among Black smokers and young adults aged 18-24.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk perceptions of menthol cigarettes compared with nonmenthol cigarettes among New Jersey adults. Wackowski, OA., Delnevo, CD., Lewis, MJ.[2021]

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 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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Cigarette filter ventilation, smoking topography, and subjective effects: A mediational analysis. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Menthol cigarette smoking in the COPDGene cohort: relationship with COPD, comorbidities and CT metrics. [2023]

3. Greece pubmed.ncbi.nlm.nih.gov

The health effects of menthol cigarettes as compared to non-menthol cigarettes. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Possible effects on smokers of cigarette mentholation: a review of the evidence relating to key research questions. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Differential trends in cigarette smoking in the USA: is menthol slowing progress? [2022]

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

Menthol should not be given a free pass based on studies of biomarkers of toxicity. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Risk perceptions of menthol cigarettes compared with nonmenthol cigarettes among New Jersey adults. [2021]

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

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

10. 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]

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

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