Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
312 participants
INTERVENTIONAL
2024-01-30
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active arm, low concentration (18 mg/mL) nicotine salt e-liquids
Smoking cessation counseling
Smoking cessation counseling at baseline, week 1, and week 4.
Open system vape device and nicotine salt e-liquids
Ad libitum use of nicotine salt e-liquids during three months.
Active arm, high concentration (59 mg/mL) nicotine salt e-liquids
Smoking cessation counseling
Smoking cessation counseling at baseline, week 1, and week 4.
Open system vape device and nicotine salt e-liquids
Ad libitum use of nicotine salt e-liquids during three months.
Control group
Receive only smoking cessation counseling
Smoking cessation counseling
Smoking cessation counseling at baseline, week 1, and week 4.
Interventions
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Smoking cessation counseling
Smoking cessation counseling at baseline, week 1, and week 4.
Open system vape device and nicotine salt e-liquids
Ad libitum use of nicotine salt e-liquids during three months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Swiss National Science Foundation
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Evangelia Liakoni, MD
Role: PRINCIPAL_INVESTIGATOR
Inselspital, Bern University Hospital
Locations
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Inselspital
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BASEC-ID: 2020-01875
Identifier Type: -
Identifier Source: org_study_id
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