Nicotine DependenceNCT04170907
Pharmacokinetics and Pharmacodynamics of Different Nicotine Salt Concentration Vape System Pods and Free-base Nicotine
A study testing standardized vaping protocol in people with Nicotine Dependence, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- standardized vaping protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Apr 2022to 30 Aug 2022
- 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
- Men or women, age 18 or older at screening, who have used electronic cigarettes and/or smoked at least 5 cigarettes per day in the past 30 days
- Saliva cotinine of > 50 ng/mL at screening
- No clinically significant findings on the physical examination at screening
- Ability to communicate well with the investigator and to understand and comply with the requirements of the study
- Women of child-bearing age: willingness of using a reliable contraception method during the study
- Signed informed consent
Who cannot join
- Known hypersensitivity/allergy to a content of the e-liquid
- Pregnancy or breast feeding
- BMI < 18 or > 28 kg/m2 at screening
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
- Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation
- Treatment with an investigational drug within 30 days prior to screening
Show all 10Show fewer
- Treatment with prescribed or over-the-counter (OTC) medications with potential influence on CYP2A6 function within 1 week prior to screening (with the exception of contraception)
- History or clinical evidence of any disease (e.g. gastrointestinal tract-disease) and/or existence of any surgical or medical condition, which in the opinion of the investigator might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity
- 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.
Switzerland1 site
Inselspital, University Hospital Bern
Bern, Canton of Bern, 3010
About this study
Official title: Randomized Crossover Study Comparing the Pharmacokinetics and Pharmacodynamics of Two Different Nicotine Salt Concentrations and Free-base Nicotine Using an Open Vape Pod System
Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system
Read the detailed description
On each study day, one puff will be taken with the assigned product every 30 seconds (total of 10 puffs). Blood samples will be collected to measure nicotine 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff using the modified Minnesota Nicotine Withdrawal Scale (MNWS), the Tiffany Questionnaire on Smoking Urges (QSU), and the Positive and Negative Affect Schedule (PANAS) questionnaires. Respiratory symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects of the assigned product (e.g. satisfying, calming, pleasant, vape another one right now) will also be assessed using visual analog scales.
- Conditions
- Nicotine Dependence
- Being tested
- standardized vaping protocol
- Keywords
- nicotine, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized vaping protocolOther
The following questionnaires will first be completed: Modified Minnesota Nicotine Withdrawal Scale, Tiffany Questionnaire on Smoking Urges-Brief total (global) craving score, Positive and Negative Affect Schedule. The assigned product will then be given to the participant, and one puff will be taken every 30 seconds (total of 10 puffs). Blood samples will be collected 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff. Respiratory Symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects will also be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine salt 20 mg/mL | Other | Vaping of nicotine salt e-liquids with a nicotine concentration of 20 mg/mL. Receives: Other: standardized vaping protocol |
| Nicotine salt 40 mg/mL | Other | Vaping of nicotine salt e-liquids with a nicotine concentration of 40 mg/mL. Receives: Other: standardized vaping protocol |
| Free-base nicotine 20 mg/mL | Other | Vaping of free-base nicotine e-liquids with a nicotine concentration of 20 mg/mL. Receives: Other: standardized vaping protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Peak Plasma Concentration (Cmax)
Comparison of nicotine Cmax between groups
Measured: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Secondary outcomes (13)
Area under the plasma concentration versus time curve (AUC)
Comparison of the nicotine AUC between groups
Measured: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Time at which the Cmax is observed (Tmax)
Comparison of the nicotine Tmax between groups
Measured: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Elimination half-life (t1/2)
Comparison of t1/2 between groups
Measured: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Genotyping of the hepatic cytochrome P450 enzyme CYP2A6
CYP2A6 genotype (allele variants)
Measured: Blood sample collection during first session
Nicotine metabolite ratio (NMR)
Nicotine clearance assessed using 3'-hydroxycotinine/cotinine ratios
Measured: Assessed at screening visit
Modified Minnesota Nicotine Withdrawal Scale (MNWS)
Excluding items relating to sleep disturbance and constipation, including eight items (angry/irritable/frustrated, anxious/nervous, depressed mood/sad, desire or craving to smoke, difficulty concentrating, increased appetite/hungry, restless and impatient), rated on a 0=none to 4=severe scale
Measured: Baseline, 10 minutes and 1 and 3 hours after the last puff
Tiffany Questionnaire on Smoking Urges-Brief (QSU) total (global) craving score
Mean of ten items, rated on a 1=strongly disagree to 7=strongly agree scale
Measured: Baseline, 10 minutes and 1 and 3 hours after the last puff
Positive and Negative Affect Schedule (PANAS)
Including items assigned as Positive or Negative Affect (each score is the sum of ten items, rated on a 1=very slightly/not at all to 5=extremely scale)
Measured: Baseline, 10 minutes and 1 and 3 hours after the last puff
Respiratory symptoms
Yes/no: shortness of breath, wheezing, cough, phlegm
Measured: At baseline and 5 minutes after the last puff
Direct effects
E.g. satisfying, calming, pleasant, vape another one right now, assessed using visual analog scales (0-100 mm) with a single word scored from left (not at all) to right (extremely)
Measured: Ten minutes post-use
Heart rate
Heart rate measurements (bpm)
Measured: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
Systolic blood pressure
Systolic blood pressure measurements (mmHg)
Measured: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
Diastolic blood pressure
Diastolic blood pressure measurements (mmHg)
Measured: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start19 Apr 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be switched in a within-subject crossover design among the three product types.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Evangelia Liakoni, MD, Principal investigator, Sponsor: Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170907
- Sponsor's protocol ID
- Nicotine PK PD
- Status last verified
- Jan 2025
- First submitted
- 12 Nov 2019
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Study Comparing the Pharmacokinetics and Pharmacodynamics of Two Different Nicotine Salt Concentrations and Free-base Nicotine Using an Open Vape Pod System
- ClinicalTrials.gov ID
- NCT04170907
- Acronym / sponsor ID
- Nicotine PK PD
- Conditions
- Nicotine Dependence
- Keywords
- nicotine, pharmacokinetics, pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 20 Nov 2019 (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.
Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system
Detailed description
On each study day, one puff will be taken with the assigned product every 30 seconds (total of 10 puffs). Blood samples will be collected to measure nicotine 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff using the modified Minnesota Nicotine Withdrawal Scale (MNWS), the Tiffany Questionnaire on Smoking Urges (QSU), and the Positive and Negative Affect Schedule (PANAS) questionnaires. Respiratory symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects of the assigned product (e.g. satisfying, calming, pleasant, vape another one right now) will also be assessed using visual analog scales.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be switched in a within-subject crossover design among the three product types.
| Arm | Type | Receives |
|---|---|---|
| Nicotine salt 20 mg/mL | Other | Other: standardized vaping protocolVaping of nicotine salt e-liquids with a nicotine concentration of 20 mg/mL. |
| Nicotine salt 40 mg/mL | Other | Other: standardized vaping protocolVaping of nicotine salt e-liquids with a nicotine concentration of 40 mg/mL. |
| Free-base nicotine 20 mg/mL | Other | Other: standardized vaping protocolVaping of free-base nicotine e-liquids with a nicotine concentration of 20 mg/mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women, age 18 or older at screening, who have used electronic cigarettes and/or smoked at least 5 cigarettes per day in the past 30 days
- Saliva cotinine of > 50 ng/mL at screening
- No clinically significant findings on the physical examination at screening
- Ability to communicate well with the investigator and to understand and comply with the requirements of the study
- Women of child-bearing age: willingness of using a reliable contraception method during the study
Key exclusion criteria (10 listed)
- Known hypersensitivity/allergy to a content of the e-liquid
- Pregnancy or breast feeding
- BMI < 18 or > 28 kg/m2 at screening
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
- Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation
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 |
|---|---|---|
| standardized vaping protocolThe following questionnaires will first be completed: Modified Minnesota Nicotine Withdrawal Scale, Tiffany Questionnaire on Smoking Urges-Brief total (global) craving score, Positive and Negative Affect Schedule. The assigned product will then be given to the participant, and one puff will be taken every 30 seconds (total of 10 puffs). Blood samples will be collected 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff. Respiratory Symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects will also be assessed. | Other | Free-base nicotine 20 mg/mL, Nicotine salt 20 mg/mL, Nicotine salt 40 mg/mL |
Primary outcome
Nicotine Peak Plasma Concentration (Cmax)
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Comparison of nicotine Cmax between groups
13 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Time at which the Cmax is observed (Tmax)
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Elimination half-life (t1/2)
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Genotyping of the hepatic cytochrome P450 enzyme CYP2A6
Time frame: Blood sample collection during first session
Nicotine metabolite ratio (NMR)
Time frame: Assessed at screening visit
Modified Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: Baseline, 10 minutes and 1 and 3 hours after the last puff
Tiffany Questionnaire on Smoking Urges-Brief (QSU) total (global) craving score
Time frame: Baseline, 10 minutes and 1 and 3 hours after the last puff
Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline, 10 minutes and 1 and 3 hours after the last puff
Respiratory symptoms
Time frame: At baseline and 5 minutes after the last puff
Direct effects
Time frame: Ten minutes post-use
Heart rate
Time frame: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
Systolic blood pressure
Time frame: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
Diastolic blood pressure
Time frame: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
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 8 Jan 2025.
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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
Sponsor: 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 standardized vaping protocol in people with Nicotine Dependence, 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 10 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 8 Jan 2025. 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?
Nicotine Peak Plasma Concentration (Cmax) (time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff). 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 8 Jan 2025.