Frontlight ResearchEarly access
CompletedNo phase
Concentration Impact Nicotine Salt
Key facts
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 125 people enrolled
- Started
- 30 Jan 2024
- Ended
- 12 Aug 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Smoking cessation counseling
- Open system vape device and nicotine salt e-liquids
- Record updated
- 17 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Use of NRT, varenicline, or bupropion in the month prior to the screening visit
- Participation in an interventional trial within 30 days prior to the screening visit
- Known hypersensitivity/allergy to a content of the e-liquid
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- Pregnancy or breast feeding
- Intention to become pregnant during the course of the study
- Current regular use of EC or tobacco heating systems
- People who smoke tobacco combined with marijuana and do not currently want to quit marijuana use
- Legal incapacity or limited legal capacity at screening
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Active arm, low concentration (18 mg/mL) nicotine salt e-liquidsExisting treatment, for comparison
Treatment: Smoking cessation counseling and Open system vape device and nicotine salt e-liquids
- Active arm, high concentration (59 mg/mL) nicotine salt e-liquidsExisting treatment, for comparison
Treatment: Smoking cessation counseling and Open system vape device and nicotine salt e-liquids
- Control groupOther group
Receive only smoking cessation counseling
Treatment: Smoking cessation counseling
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of the Nicotine Concentration on the Efficacy of a Nicotine Salt Vape Pod System as Smoking Cessation Tool
- Record updated
- 17 August 2026