Concentration Impact Nicotine Salt (NCT04725656) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Concentration Impact Nicotine Salt
Switzerland312 participantsStarted 2024-01-30
Plain-language summary
Double-blind (for the two active arms), randomized, three-arm (two active and one control) clinical trial investigating factors (e.g. nicotine concentration) influencing the success of smoking cessation strategies and possible health risks related to nicotine salt vaping.
Who can participate
Age range
18 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:
* Adult (≥ 18 years old) smokers (at least 5 TC per day for at least 12 months)
* Motivated to quit smoking as evidenced by signing the informed consent form at trial enrolment specifying that a target quit date will be set
* Exhaled CO ≥ 10 ppm or saliva cotinine of \> 30 ng/ml (in case of borderline CO measurement of 6-10 ppm) at screening
* Willing to participate in the trial even if allocated to the control group
* Ability to communicate well with the investigator and to understand and comply with the requirements of the study
* Signed informed consent form
Exclusion Criteria:
* Known hypersensitivity/allergy to a content of the e-liquid
* Pregnancy or breast feeding
* Intention to become pregnant during the course of the study
* Current regular use of EC or tobacco heating systems
* Use of NRT, varenicline, or bupropion in the month prior to the screening visit
* People who smoke tobacco combined with marijuana and do not currently want to quit marijuana use
* Participation in an interventional trial within 30 days prior to the screening visit
* Legal incapacity or limited legal capacity at screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
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 tobacco abstinence (in terms of non-inferiority)