A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking B… (NCT06260683) | Clinical Trial Compass
RecruitingNot Applicable
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
United States1,500 participantsStarted 2024-04-10
Plain-language summary
This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.
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 old
* Smoke \>= 5 cigarettes per day for the past year
* Willing to use either an EC or NRT
* Read and speak English
* Have a smartphone
Exclusion Criteria:
* Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
* Current use of an EC \> 4 days a month
* Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
* Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
* History of cardiac event or distress within the past 3 months
* Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
* High blood pressure not controlled by medications
* Serious angina pectoris or chest pain
* Stroke within the past three months
* Known allergy to propylene glycol or vegetable glycerin
* Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
* Live in same household as another study participant
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
7-day point prevalence complete switching rate
Timeframe: At week 14
2
Biochemically verified 7-day point prevalence abstinence from cigarettes
Timeframe: At week 14
3
Cigarettes smoked per day
Timeframe: At week 14
Trial details
NCT IDNCT06260683
SponsorOhio State University Comprehensive Cancer Center