Concentration Impact Nicotine Salt

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 22, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Concentration Impact Nicotine Salt," is exploring how different levels of nicotine in vaping products can affect people's chances of successfully quitting smoking. The study aims to find out which nicotine concentrations might help smokers stop using cigarettes and to understand any health risks associated with vaping nicotine salts. It is currently recruiting participants who are adults, at least 18 years old, and have been smoking regularly for over a year. To join, you need to be motivated to quit smoking and agree to set a target quit date.

If you decide to participate, you'll be randomly assigned to one of three groups—two groups using different nicotine concentrations and one control group. Everyone will receive either a vaping product or a placebo that doesn’t contain nicotine. You'll need to be willing to follow the study's guidelines and communicate openly with the researchers. However, there are some criteria that might prevent you from joining, such as being pregnant, currently using other smoking cessation treatments, or having certain allergies. Overall, this trial is an opportunity to contribute to research that could help many people quit smoking more effectively.

Gender

ALL

Eligibility criteria

• 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