Switching Cigarette Types for Smoking Inflammation

(MINT Trial)

Overseen By Nancy C Jao, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rosalind Franklin University of Medicine and Science

Disqualifiers: Pregnancy, Heavy alcohol use, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how switching from menthol to non-menthol cigarettes affects markers in the body that might indicate early heart disease risk. The main focus is on whether menthol flavoring in cigarettes contributes to inflammation, a common sign of developing cardiovascular issues. Ideal candidates are smokers who have used menthol cigarettes daily for at least a year and own a smartphone. The trial aims to determine if changing cigarette types, such as switching to Electronic Nicotine Delivery Systems like vapes or e-cigarettes, can impact health markers linked to heart disease. As an unphased trial, it offers participants a chance to contribute to important research on smoking and heart health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that switching cigarette types is safe?

Research suggests that switching from menthol to non-menthol cigarettes might lower some health risks. Although specific data on this switch is lacking, menthol cigarettes are considered more harmful because they make smoking feel smoother, leading to deeper and longer inhalation. This increases exposure to harmful chemicals.

While this study doesn't yet have specific results, switching to non-menthol cigarettes could potentially reduce some smoking-related risks. However, it's important to remember that switching cigarette types is not the same as quitting smoking, which remains the best way to reduce health risks.

Prospective participants should note that smoking always carries health risks, but switching might help manage inflammation linked to heart disease. Consulting a healthcare professional is advisable for any questions or concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how switching from menthol to non-menthol cigarettes might impact smoking-related inflammation. Unlike other approaches that focus on smoking cessation or nicotine replacement, this method directly examines the role of menthol in exacerbating inflammation. By isolating menthol as a variable, researchers hope to better understand its specific effects, which could lead to more targeted public health recommendations and policies.

What evidence suggests that switching cigarette types could be effective for reducing smoking inflammation?

Research has shown that switching from menthol to non-menthol cigarettes might lower certain blood markers linked to heart disease. Some studies found that after making this switch, smokers often smoke fewer cigarettes and experience weaker cravings. This suggests that changing cigarette types could help reduce the risk of heart problems. In this trial, participants will switch from menthol cigarettes to non-menthol cigarettes to determine if this change can noticeably decrease smoking-related inflammation. ^{6 7 8 9 10}

Who Is on the Research Team?

Nancy C Jao, PhD

Principal Investigator

Rosalind Franklin University of Medicine and Science

Are You a Good Fit for This Trial?

This trial is for men and women aged 21-60 who smoke at least 5 menthol cigarettes daily for over a year, can use a smartphone with the LifeData app, and speak English fluently. It's not for those pregnant, breastfeeding, trying to quit smoking, heavy drinkers, users of non-menthol tobacco or illicit drugs, or with severe health/psychiatric conditions.

Inclusion Criteria

Currently uses menthol cigarettes

I am between 21 and 60 years old.

Currently own and regularly use an iOS/Android smartphone device able to download the LifeData application

Exclusion Criteria

I have a severe medical or psychiatric condition.

Current heavy alcohol use

Actively trying to quit smoking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants continue smoking menthol cigarettes to establish baseline measurements

1 week

1 visit (in-person)

Treatment

Participants switch from menthol to non-menthol cigarettes, with biomarkers and smoking behavior monitored

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cigarette Type Switching

Trial Overview The study investigates if switching cigarette types affects markers in the blood that signal inflammation linked to heart disease risk. Participants will change their usual menthol cigarettes as part of the research to see how it influences these biomarkers.

How Is the Trial Designed?

Group I: Cigarette Type Switching Experimental Treatment 1 Intervention

Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes

Who Is Running the Clinical Trial?

Rosalind Franklin University of Medicine and Science

Lead Sponsor

Trials

15

Recruited

690+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Electronic nicotine delivery systems (ENDS), like e-cigarettes, are partially substitutable for traditional combustible cigarettes, indicating that as e-cigarette use increases, some smokers may reduce their cigarette consumption.

Current users of e-cigarettes have a higher likelihood of quitting combustible cigarettes compared to those who have never used e-cigarettes, with an odds ratio of 1.19, suggesting that e-cigarettes may aid in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching from cigarettes to electronic nicotine delivery system: rapid systematic review and meta-analysis and economic aspects. Ciapponi, A., Rodríguez Cairoli, F., Solioz, G., et al.[2022]

Over half of the surveyed electronic nicotine delivery systems (ENDS) users (55.9%) also used other tobacco products, indicating a significant prevalence of polytobacco use among adolescents and young adults, which raises concerns about increased risk for nicotine addiction and health issues.

Exclusive ENDS users were more likely to perceive ENDS as less harmful than cigarettes, suggesting that risk perception influences usage patterns; those who viewed ENDS as equally or more harmful were less likely to be exclusive users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polytobacco Use Among a Nationally Representative Sample of Adolescent and Young Adult E-Cigarette Users. King, JL., Reboussin, D., Cornacchione Ross, J., et al.[2020]

In a study of 1208 men aged 19-65, electronic cigarette use was linked to increased levels of systemic inflammation, as indicated by higher serum high-sensitivity C-reactive protein levels, suggesting a potential risk for cardiovascular disease.

The study also found that electronic cigarette users had elevated uric acid levels and a higher likelihood of hyperuricemia, indicating that e-cigarettes may have harmful metabolic effects similar to those of traditional cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Electronic Cigarette Use and Levels of High-Sensitivity C-Reactive Protein and Uric Acid. Moon, J., Lee, H., Kong, M., et al.[2020]

E-cigarettes and vaping products, while showing some harm reduction benefits for smoking cessation, still pose significant health risks, particularly among young users who vape THC, as highlighted by the rise in EVALI-related injuries and deaths.

The review emphasizes the need for ongoing monitoring of vaping trends and health impacts, as the popularity of electronic nicotine delivery systems continues to raise concerns despite a decrease in severe incidents since 2019.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

World vaping update. Striley, CW., Nutley, SK.[2021]

This umbrella review aims to synthesize findings from various systematic reviews on the effectiveness of electronic nicotine delivery systems (ENDS) for smoking cessation, comparing quit rates with other established treatments.

The review will assess the quality and bias of existing studies, providing a comprehensive analysis of ENDS' effectiveness and informing future treatment guidelines and policies for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Cigarette Use and the Cessation of Tobacco Cigarette Smoking: Protocol for an Umbrella Review. O'Leary, R., Polosa, R.[2023]

In 2018, an estimated 885 cases of liquid nicotine poisoning among children under 5 were treated in U.S. emergency departments, indicating a concerning trend in exposure.

The majority of these poisoning cases (90%) were treated and released, with ingestion being the most common route of exposure (99.4%), highlighting the need for increased public awareness and safety measures regarding liquid nicotine products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery system (ENDS) liquid nicotine exposure in young children presenting to US emergency departments, 2018. Chang, JT., Rostron, BL.[2022]

Smokers are increasingly using e-cigarettes or electronic nicotine delivery systems (ENDS) as alternatives to traditional combustible tobacco products like cigarettes and cigars.

E-cigarettes are often seen as a tool for smoking cessation, providing a different method for nicotine delivery compared to conventional smoking methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of E-Cigarettes and Vaping. [2020]

Many electronic nicotine delivery systems (ENDS) contain varying amounts of nicotine that do not match the concentrations labeled on the cartridges, indicating a lack of consistency and reliability in these products.

The presence of chemicals like propylene glycol and glycerol in ENDS raises safety concerns, as limited information is available about the actual contents, which could affect both recreational users and those attempting to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: regulatory and safety challenges: Singapore perspective. Cheah, NP., Chong, NW., Tan, J., et al.[2022]

A systematic review of 79 studies found that electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP) cause respiratory damage through mechanisms similar to those of conventional cigarettes, as well as new pathways specific to these devices.

The evidence suggests that ENDS and HTP pose significant health risks, particularly to young users, challenging the tobacco industry's claims of these products being safer alternatives and highlighting the need for regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Damage Caused by Heated Tobacco Products and Electronic Nicotine Delivery Systems: A Systematic Review. Bravo-Gutiérrez, OA., Falfán-Valencia, R., Ramírez-Venegas, A., et al.[2021]

Quitting electronic nicotine delivery systems (ENDS) does not appear to help current smokers abstain from combusted tobacco products (CTPs), as shown in a study of 1525 adults with no significant differences in smoking abstinence between those who quit ENDS and those who continued using them.

For former CTP smokers, quitting ENDS was linked to a lower likelihood of CTP abstinence in the short term, suggesting that stopping ENDS may increase the risk of returning to smoking, although this effect was not observed in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarette cessation and transitions in combusted tobacco smoking status: longitudinal findings from the US FDA PATH Study. Klemperer, EM., Bunn, JY., Palmer, AM., et al.[2023]

Citations

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Effects on Smoking Behavior of Switching Menthol ... After switching to non-menthol cigarettes, some studies have found that the number of cigarettes smoked and severity of craving decreased whereas motivation to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06232447?term=MENTHOL%20AND%20NICOTINE&rank=5

Menthol , Inflammation, and Nicotine Transition Study (MINT) The goal of this study is to examine how switching from menthol (MC) to non-menthol (NMC) cigarette smoking may impact biomarkers of systemic inflammation, ...

3. withpower.com withpower.com/trial/phase-inflammatory-responses-2024-1723b

Switching Cigarette Types for Smoking Inflammation This trial examines if switching from menthol to non-menthol cigarettes affects inflammation markers in the blood, which are linked to heart disease risk.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5896432/

Effects of Switching to the Menthol Tobacco Heating System ... This randomized, three-arm parallel-group study showed that switching from mCCs to mTHS was associated with improvements in clinically relevant risk markers, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0091743525000921

The effects of switching to the standardized research ... This pilot study examined the effects of providing the NIDA standardized research electronic cigarette (SREC) on smoking behaviors and inflammatory biomarkers ...

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Health impacts of electronic nicotine delivery systems Currently, there are insufficient long-term data to determine whether ENDS are effective for tobacco smoking cessation conclusively. Some ...

7. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2025/05/08/tc-2024-059019

Electronic cigarette use, related health outcomes and ... E-cigarette use is associated with several adverse acute health outcomes; there is currently insufficient longitudinal evidence to predict ...

8. journals.physiology.org journals.physiology.org/doi/10.1152/ajpheart.00272.2025

The impact of e-cigarettes versus traditional ... Electronic cigarettes (e-cigarettes) have emerged as potential harm reduction tools for conventional smokers, with proponents claiming reduced health risks.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1931524425000118

Assessing the impact of e-cigarettes on human barrier ... Research indicates that e-cigarette vapor can disrupt airway epithelial barrier function, leading to increased permeability and inflammation. Chronic exposure ...

10. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-021-01737-5

An updated overview of e-cigarette impact on human health Results of toxicological analyses suggest that e-cigarettes can be safer than conventional cigarettes, although harmful effects from short-term e-cigarette use ...