Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American M… (NCT05023096) | Clinical Trial Compass
CompletedNot Applicable
Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers
United States71 participantsStarted 2022-04-14
Plain-language summary
This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.
Who can participate
Age range
21 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:
* 21+ years of age
* identify as Black/African American (single or multi-race)
* have used ≥5 cigarettes per day for ≥1 year
* biochemically confirmed cigarette smoking status
* regular cigarette brand is flavored to taste like menthol or mint
* ENDS use in the past 3 months
* report no intent to quit smoking in the next 6 months
* previous quit attempt using evidence-based method
* have a working mobile phone with a texting/data plan
* are willing receive phone calls/text messages and complete internet-based/online surveys related to the study.
* read and write in English
Exclusion Criteria:
* are unwilling to use ENDS as part of the trial
* unstable or significant medical condition in the past 12 months
* report any other illegal drug use in past 30 days
* report intent to become pregnant or current pregnancy/breastfeeding
* report any other condition that may affect participant safety or not allow them to fully participate in the study
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.