Switching Cigarette Types for Smoking Inflammation
(MINT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rosalind Franklin University of Medicine and Science
Disqualifiers: Pregnancy, Heavy alcohol use, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
14678How 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.
128910Eligibility 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
+2 more
Exclusion Criteria
I have a severe medical or psychiatric condition.
Current heavy alcohol use
Actively trying to quit smoking
+2 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Cigarette Type SwitchingExperimental Treatment1 Intervention
Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rosalind Franklin University of Medicine and ScienceNorth Chicago, IL
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Who Is Running the Clinical Trial?
Rosalind Franklin University of Medicine and ScienceLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Polytobacco Use Among a Nationally Representative Sample of Adolescent and Young Adult E-Cigarette Users. [2020]Electronic nicotine delivery systems (ENDS) are adolescents' most commonly used tobacco product and young adults' second most used. Little is known about ENDS use alongside other tobacco products (polytobacco use) and whether exclusive ENDS users differ from polytobacco ENDS users.
Switching from cigarettes to electronic nicotine delivery system: rapid systematic review and meta-analysis and economic aspects. [2022]To assess how and in what extent the electronic nicotine delivery systems (ENDS) use substituted the consumption of traditional combustible cigarettes (c-cigarettes, c-cig).
E-cigarette cessation and transitions in combusted tobacco smoking status: longitudinal findings from the US FDA PATH Study. [2023]Electronic nicotine delivery systems (ENDS) can help people to quit smoking combusted tobacco products (CTPs), but most current and former smokers who use ENDS also intend to quit ENDS. This analysis measured whether ENDS cessation among current and former CTP smokers is associated with changes in CTP smoking or abstinence.
Electronic nicotine delivery systems: regulatory and safety challenges: Singapore perspective. [2022]Many electronic nicotine delivery systems (ENDS) are marketed as safer tobacco alternative products or effective cessation therapies. ENDS samples were evaluated for design features, including nicotine and glycols content. This could be useful in developing a legal framework to handle ENDS.
e-Cigarette Use and the Cessation of Tobacco Cigarette Smoking: Protocol for an Umbrella Review. [2023]Electronic nicotine delivery systems (ENDS), commonly called e-cigarettes, have been examined in clinical studies for their effects on tobacco smoking cessation. In the past 2 years, a dozen or more systematic reviews on ENDS and cigarette smoking cessation have been published that present differing conclusions and recommendations on the use of ENDS.
Electronic nicotine delivery system (ENDS) liquid nicotine exposure in young children presenting to US emergency departments, 2018. [2022]Increased use of electronic nicotine delivery systems (ENDS) in the United States (U.S.) has been related to acute adverse events from liquid nicotine exposure. Previous studies have reported on these events through 2017.
World vaping update. [2021]Although death and injury related to e-cigarette use and vaping products has decreased since the peak in 2019, concern over the popularity of electronic nicotine delivery systems (ENDS - a term which includes vape pens, electronic or e-cigarettes, and products that produce vapor for inhaling rather than combusting to produce smoke) continues. ENDS are used as an aid to quit smoking and for harm reduction.
Use of E-Cigarettes and Vaping. [2020]Smokers who use combustible tobacco products, such as cigarettes, cigars, and pipes, have been turning to electronic cigarettes (e-cigarettes) or electronic nicotine delivery systems (ENDS) as an alternative to combustible tobacco products and as a smoking cessation tool. Use of e-cigarettes has been referred to as vaping, with numerous terms for these devices, such as vaporizers, vape pens, hookah pens, e-cigs, or e-pipes.
Lung Damage Caused by Heated Tobacco Products and Electronic Nicotine Delivery Systems: A Systematic Review. [2021]The tobacco industry promotes electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP) as a safer alternative to conventional cigarettes with misleading marketing sustained by studies with conflict of interest. As a result, these devices sell without regulations and warnings about their adverse effects on health, with a growing user base targeting young people. This systematic review aimed to describe the adverse effects on the respiratory system in consumers of these devices. We conducted a systematic review and bibliometric analysis of 79 studies without conflict of interest evaluating ENDS and HTP effects in the respiratory system in experimental models, retrieved from the PubMed database. We found that the damage produced by using these devices is involved in pathways related to pulmonary diseases, involving mechanisms previously reported in conventional cigarettes as well as new mechanisms particular to these devices, which challenges that the tobacco industry's claims. The present study provides significant evidence to suggest that these devices are an emerging public health problem and that they should be regulated or avoided.
Association Between Electronic Cigarette Use and Levels of High-Sensitivity C-Reactive Protein and Uric Acid. [2020]The present study investigated whether electronic cigarette use, which is becoming increasingly common, was related to systemic inflammation that may lead to cardiovascular disease, similar to conventional cigarette smoking. The study included 1208 men (19-65 years old) who participated in the 7th Korean National Health and Nutrition Examination Survey (2016). The participants were categorized as electronic cigarette users, conventional cigarette users, and nonsmokers. Serum high-sensitivity C-reactive protein was used as an inflammatory index, and uric acid level was used as a metabolic indicator. After adjusting for confounding factors, electronic cigarette use was significantly associated with elevated serum high-sensitivity C-reactive protein levels (β = 1.326, P = .002), uric acid levels (β = 0.400, P = .042), and hyperuricemia (uric acid level of >7 mg/mL; odds ratio = 2.67, 95% confidence interval = 1.27-5.58). These findings suggest that electronic cigarette use may be associated with systemic inflammation markers, similar to conventional cigarette use.