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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