Smoking CessationCINSNCT04725656
Concentration Impact Nicotine Salt
A study testing Smoking cessation counseling and Open system vape device and nicotine salt e-liquids in people with Smoking Cessation and Vaping, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Vaping
- What is being tested?
- Smoking cessation counseling and Open system vape device and nicotine salt e-liquids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jan 2024to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Nicotine Concentration on the Efficacy of a Nicotine Salt Vape Pod System as Smoking Cessation Tool
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.
Read the 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 index (BMI) and exhaled carbon monoxide (CO) will be assessed, and a physical examination will be performed. Saliva samples will be collected for cotinine and nicotine metabolite ratio (NMR) measurement, urine samples for urinary anabasine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), nicotine metabolites, tobacco-specific nitrosamines (TSNA), and VOC, and blood samples for genotyping, steroid levels, blood lipids, creatinine, and glucose.
After randomization the open system vape device and the nicotine salt e-liquids will be distributed to the participants of the two active arms. Use of e-liquids in the active arms will be ad libitum during three months and will be monitored by returned empty e-liquid bottles.
All groups will receive smoking cessation counseling at baseline, week 1, and week 4. Visits at the center at baseline, week 4, and 3 months will include questionnaires regarding TC and EC use, respiratory symptoms, liking, and adverse events, measurement of heart rate, blood pressure, BMI, blood steroid levels, HDL, LDL, creatinine and glucose, and measurement of urinary TSNA, VOC and nicotine metabolites. For participants self-reporting TC abstinence, exhaled CO validation and urinary anabasine and NNAL will be collected to verify tobacco abstinence.
A follow-up visit also assessing TC abstinence will take place at 6 months.
- Conditions
- Smoking Cessation, Vaping
- Being tested
- Smoking cessation counseling, Open system vape device and nicotine salt e-liquids
- Medical subject headings
- Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counselingProcedure or surgery
Smoking cessation counseling at baseline, week 1, and week 4.
Open system vape device and nicotine salt e-liquidsOther
Ad libitum use of nicotine salt e-liquids during three months.
| Study group | Role | What they receive |
|---|---|---|
| Active arm, low concentration (18 mg/mL) nicotine salt e-liquids | Active comparator | Not described Receives: Procedure: Smoking cessation counseling; Other: Open system vape device and nicotine salt e-liquids |
| Active arm, high concentration (59 mg/mL) nicotine salt e-liquids | Active comparator | Not described Receives: Procedure: Smoking cessation counseling; Other: Open system vape device and nicotine salt e-liquids |
| Control group | Other | Receive only smoking cessation counseling Receives: Procedure: Smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence tobacco abstinence (in terms of non-inferiority)
Defined as no smoking, i.e. "not a puff", self-reported and confirmed by exhaled carbon monoxide (<10 ppm) and urinary anabasine levels (<3 ng/mL) when using low vs. high nicotine salt concentration e-liquids.
Measured: 1 month
Volume of e-liquid used (in terms of superiority)
Volume of e-liquid used when using low vs. high nicotine salt concentration e-liquids.
Measured: 1 month
Secondary outcomes (15)
7-day point prevalence tobacco cigarette abstinence
Same as primary outcome using a less strict definition of tobacco cigarette abstinence, i.e. self-report of smoking no more than 5 cigarettes
Measured: 1 month
Continuous tobacco cigarette abstinence
Self-reported continuous abstinence at 1 month (confirmed by exhaled carbon monoxide and urinary anabasine) using the stricter, i.e. "not a puff" and the less strict, i.e. "no more than 5 cigarettes" definition
Measured: 1 month
7-day point prevalence tobacco cigarette abstinence
Self-reported 7-day point prevalence abstinence at 3 and 6 months (confirmed by exhaled carbon monoxide and urinary anabasine) using the stricter, i.e. "not a puff" and the less strict, i.e. "no more than 5 cigarettes" definition
Measured: 3 and 6 months
Continuous tobacco cigarette abstinence
Self-reported continuous abstinence at 3 and 6 months (confirmed by exhaled carbon monoxide and urinary anabasine) using the stricter, i.e. "not a puff" and the less strict, i.e. "no more than 5 cigarettes" definition, and when allowing a 2-week "grace period" from the target quit date
Measured: 3 and 6 months
Number of drop-outs
Measured: Through study completion
Time of dropping out
Measured: Through study completion
Urinary volatile organic compounds (VOC)
Change of non-nicotine toxicants (VOC) from baseline to 1 month and 3 months of nicotine salt use
Measured: 1 and 3 months
Tobacco-specific nitrosamines (TSNA)
Change of non-nicotine toxicants (TSNA) from baseline to 1 month and 3 months of nicotine salt use
Measured: 1 and 3 months
Liking/rating of trial product (active arms)
Questions regarding helpfulness in refraining from smoking, how satisfying and how good the e-cigarette tastes compared to the tobacco cigarettes, if they would recommend the assigned trial product to another smoker, and any potential practical problems they might have with the handling.
Measured: 1 and 3 months
Respiratory symptoms
Checklist with specific questions regarding shortness of breath, wheezing, cough or phlegm
Measured: Up to 6 months
Adverse events
Checklist with specific questions regarding presence or absence of nausea, sleep disturbance, throat/mouth irritation or other
Measured: Up to 6 months
Total nicotine amount vaped
Measured: 1 and 3 months
Total volume of e-liquid consumed
Measured: 1 and 3 months
Steroid profiles
Steroid profiles in saliva, blood and urine
Measured: Baseline, 1, 3 and 6 months
Number of cigarettes smoked per day among those who fail to quit
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start30 Jan 2024
- Primary completion2 Mar 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Evangelia Liakoni, MD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725656
- Sponsor's protocol ID
- BASEC-ID: 2020-01875
- Acronym
- CINS
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that relates to individual, primary publications (and not the whole study database as such) will be deposited in the Bern Open Repository and Information System (BORIS). All efforts will be made to protect privacy and to de-identify the data. Data will be shared on request under the following conditions: A meaningful study question by the requester, outline of the planned analyses, valid methodology, signed data sharing agreement that contains a confidentiality agreement in case of sensitive data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Nicotine Concentration on the Efficacy of a Nicotine Salt Vape Pod System as Smoking Cessation Tool
- ClinicalTrials.gov ID
- NCT04725656
- Acronym / sponsor ID
- CINS / BASEC-ID: 2020-01875
- Conditions
- Smoking Cessation, Vaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 index (BMI) and exhaled carbon monoxide (CO) will be assessed, and a physical examination will be performed. Saliva samples will be collected for cotinine and nicotine metabolite ratio (NMR) measurement, urine samples for urinary anabasine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), nicotine metabolites, tobacco-specific nitrosamines (TSNA), and VOC, and blood samples for genotyping, steroid levels, blood lipids, creatinine, and glucose.
After randomization the open system vape device and the nicotine salt e-liquids will be distributed to the participants of the two active arms. Use of e-liquids in the active arms will be ad libitum during three months and will be monitored by returned empty e-liquid bottles.
All groups will receive smoking cessation counseling at baseline, week 1, and week 4. Visits at the center at baseline, week 4, and 3 months will include questionnaires regarding TC and EC use, respiratory symptoms, liking, and adverse events, measurement of heart rate, blood pressure, BMI, blood steroid levels, HDL, LDL, creatinine and glucose, and measurement of urinary TSNA, VOC and nicotine metabolites. For participants self-reporting TC abstinence, exhaled CO validation and urinary anabasine and NNAL will be collected to verify tobacco abstinence.
A follow-up visit also assessing TC abstinence will take place at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active arm, low concentration (18 mg/mL) nicotine salt e-liquids | Active comparator | Procedure: Smoking cessation counseling, Other: Open system vape device and nicotine salt e-liquids |
| Active arm, high concentration (59 mg/mL) nicotine salt e-liquids | Active comparator | Procedure: Smoking cessation counseling, Other: Open system vape device and nicotine salt e-liquids |
| Control group | Other | Procedure: Smoking cessation counselingReceive only smoking cessation counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation counselingSmoking cessation counseling at baseline, week 1, and week 4. | Procedure or surgery | Active arm, high concentration (59 mg/mL) nicotine salt e-liquids, Active arm, low concentration (18 mg/mL) nicotine salt e-liquids, Control group |
| Open system vape device and nicotine salt e-liquidsAd libitum use of nicotine salt e-liquids during three months. | Other | Active arm, high concentration (59 mg/mL) nicotine salt e-liquids, Active arm, low concentration (18 mg/mL) nicotine salt e-liquids |
Primary outcome
7-day point prevalence tobacco abstinence (in terms of non-inferiority)
Time frame: 1 month
Defined as no smoking, i.e. "not a puff", self-reported and confirmed by exhaled carbon monoxide (<10 ppm) and urinary anabasine levels (<3 ng/mL) when using low vs. high nicotine salt concentration e-liquids.
Volume of e-liquid used (in terms of superiority)
Time frame: 1 month
Volume of e-liquid used when using low vs. high nicotine salt concentration e-liquids.
15 secondary outcomes
7-day point prevalence tobacco cigarette abstinence
Time frame: 1 month
Continuous tobacco cigarette abstinence
Time frame: 1 month
7-day point prevalence tobacco cigarette abstinence
Time frame: 3 and 6 months
Continuous tobacco cigarette abstinence
Time frame: 3 and 6 months
Number of drop-outs
Time frame: Through study completion
Time of dropping out
Time frame: Through study completion
Urinary volatile organic compounds (VOC)
Time frame: 1 and 3 months
Tobacco-specific nitrosamines (TSNA)
Time frame: 1 and 3 months
Liking/rating of trial product (active arms)
Time frame: 1 and 3 months
Respiratory symptoms
Time frame: Up to 6 months
Adverse events
Time frame: Up to 6 months
Total nicotine amount vaped
Time frame: 1 and 3 months
Total volume of e-liquid consumed
Time frame: 1 and 3 months
Steroid profiles
Time frame: Baseline, 1, 3 and 6 months
Number of cigarettes smoked per day among those who fail to quit
Time frame: Through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Data that relates to individual, primary publications (and not the whole study database as such) will be deposited in the Bern Open Repository and Information System (BORIS). All efforts will be made to protect privacy and to de-identify the data. Data will be shared on request under the following conditions: A meaningful study question by the requester, outline of the planned analyses, valid methodology, signed data sharing agreement that contains a confidentiality agreement in case of sensitive data.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelia Liakoni, MD principal investigator
Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation counseling and Open system vape device and nicotine salt e-liquids in people with Smoking Cessation and Vaping, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence tobacco abstinence (in terms of non-inferiority) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.