A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers (NCT07172438) | Clinical Trial Compass
TerminatedNot Applicable
A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers
Stopped: The study was terminated due to data integrity concerns that affected the ability to reliably assess the study endpoints.
United States668 participantsStarted 2025-09-17
Plain-language summary
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, or non-tobacco/non-menthol-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
Who can participate
Age range
21 Years – 65 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
. Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English
. Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent
. All female (assigned at birth) candidate participants who agree during the pre-screener to receive and take a home pregnancy test prior to the SEV, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
. Currently smoke at least 10 cigarettes on smoking days in the past 30 days
. Smoke cigarettes regularly for at least 12 months
. Smoke cigarettes on 15 or more of the past 30 days
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
1
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
. Smoked at least 100 cigarettes in their lifetime prior to the screening and enrollment visit.
. Must indicate smoking factory-made filtered menthol and/or non-menthol cigarettes as their primary nicotine product (Occasional use of other tobacco- or nicotine-containing products is acceptable)
Exclusion criteria
. Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
. Female participants who self-report not using adequate methods to prevent pregnancy
. Persons with pacemakers or other embedded electronic medical devices fitted
. Persons who self-report heart disease, high blood pressure, diabetes, cancer, Chronic Obstructive Pulmonary Disease, emphysema, asthma or other lung/breathing conditions, a previous history of heart attack or stroke, or are taking medication for depression.
. Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including those listed below:
. Carvone (L-)
. Benzyl alcohol
. Participants who have used ENDS, nicotine pouch or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products on 5 or more days in the past 30 days