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

Trial Summary

What is the purpose of this trial?

This trial examines if switching from menthol to non-menthol cigarettes affects inflammation markers in the blood, which are linked to heart disease risk. It targets menthol cigarette smokers to see if this change can improve their 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 data supports the effectiveness of the treatment Cigarette Type Switching, Electronic Nicotine Delivery Systems (ENDS), Vapes, Vaporizers, Vape Pens, Hookah Pens, E-Cigarettes, E-Cigs, E-Cigars, E-Pipes for smoking inflammation?

Research suggests that electronic nicotine delivery systems (ENDS) can help people reduce or quit smoking traditional cigarettes, which may lead to decreased smoking-related inflammation. However, the effectiveness of ENDS specifically for reducing inflammation is not directly addressed in the studies. ^{1 2 3 4 5}

Is switching to e-cigarettes or vaping generally safe for humans?

E-cigarettes and vaping devices, also known as electronic nicotine delivery systems (ENDS), are often marketed as safer alternatives to traditional smoking. However, there have been reports of adverse events, particularly from liquid nicotine exposure, and concerns remain about their safety despite a decrease in related injuries since 2019. ^{1 4 6 7 8}

How does switching cigarette types affect smoking-related inflammation?

Switching from traditional cigarettes to electronic nicotine delivery systems (ENDS) or heated tobacco products (HTP) is marketed as a safer alternative, but studies show they can still cause lung damage and systemic inflammation similar to conventional cigarettes. This treatment is unique because it involves changing the type of cigarette rather than quitting smoking entirely, which may not reduce inflammation as intended. ^{1 2 8 9 10}

Research Team

Nancy C Jao, PhD

Principal Investigator

Rosalind Franklin University of Medicine and Science

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Polytobacco Use Among a Nationally Representative Sample of Adolescent and Young Adult E-Cigarette Users. [2020]

2. Peru pubmed.ncbi.nlm.nih.gov

Switching from cigarettes to electronic nicotine delivery system: rapid systematic review and meta-analysis and economic aspects. [2022]

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

E-cigarette cessation and transitions in combusted tobacco smoking status: longitudinal findings from the US FDA PATH Study. [2023]

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

Electronic nicotine delivery systems: regulatory and safety challenges: Singapore perspective. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

e-Cigarette Use and the Cessation of Tobacco Cigarette Smoking: Protocol for an Umbrella Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

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

World vaping update. [2021]

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

Use of E-Cigarettes and Vaping. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Lung Damage Caused by Heated Tobacco Products and Electronic Nicotine Delivery Systems: A Systematic Review. [2021]

10. China pubmed.ncbi.nlm.nih.gov

Association Between Electronic Cigarette Use and Levels of High-Sensitivity C-Reactive Protein and Uric Acid. [2020]