RecruitingNot Applicable

Menthol, Inflammation, and Nicotine Transition Study

United States68 participantsStarted 2024-03-26

Plain-language summary

This study will focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk.

Who can participate

Age range

21 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * Men and women between 21-85 years old * Currently uses menthol cigarettes * Daily smoking rate of ≥5 cigarettes/day for ≥1 year * Currently own and regularly use an iOS/Android smartphone device able to download the LifeData application * Able to read and communicate fluently in English Exclusion criteria * Currently pregnant or breastfeeding * Actively trying to quit smoking * Current heavy alcohol use * Frequent use of non-menthol cigarettes, other smoking products, or illicit substances * History of severe medical/psychiatric condition or treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

high sensitivity C-reactive protein

Timeframe: 4 weeks

Fibrinogen

Timeframe: 4 weeks

Cytokine Panel 13

Timeframe: 4 weeks

Trial details

NCT IDNCT06232447

SponsorRosalind Franklin University of Medicine and Science

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Nancy C Jao, PhD

847-578-8747 nancy.jao@rosalindfranklin.edu

View on ClinicalTrials.gov More Cigarette Smoking trials

Who can participate

Age range

21 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.