Status:
RECRUITING
Concentration Impact Nicotine Salt
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Smoking Cessation
Vaping
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cessati...
Detailed Description
At the clinic screening visit demographics, smoking (including the Fagerström Test for Cigarette Dependence (FTCD) Questionnaire) and medical history, concomitant medication, vital signs, body mass in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT04725656
Start Date
January 30 2024
End Date
December 31 2025
Last Update
March 28 2025
Active Locations (1)
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1
Inselspital
Bern, Switzerland