Concentration Impact Nicotine Salt
Impact of the Nicotine Concentration on the Efficacy of a Nicotine Salt Vape Pod System as Smoking Cessation Tool
Insel Gruppe AG, University Hospital Bern
312 participants
Jan 30, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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
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Interventions
Smoking cessation counseling at baseline, week 1, and week 4.
Ad libitum use of nicotine salt e-liquids during three months.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04725656