Investigating nicotine salt concentration effects on smoking cessation
Impact of the Nicotine Concentration on the Efficacy of a Nicotine Salt Vape Pod System as Smoking Cessation Tool
This study is testing whether different levels of nicotine in vaping products can help people quit smoking and what health effects they might have.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04725656 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind, randomized, three-arm investigation focusing on how different nicotine concentrations in vaping products influence smoking cessation success and potential health risks. Participants will undergo a thorough screening process, including assessments of smoking habits, medical history, and vital signs. After randomization, participants will use an open system vape device with nicotine salt e-liquids for three months, while receiving smoking cessation counseling and regular health evaluations. The study aims to collect various biological samples to analyze nicotine metabolism and validate smoking abstinence.
Who should consider this trial
Good fit: Ideal candidates are adult smokers aged 18 and older who have been smoking at least 5 cigarettes per day for the past year and are motivated to quit.
Not a fit: Patients who are pregnant, breastfeeding, or have a known allergy to e-liquid components will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective smoking cessation strategies using nicotine salt vaping.
How similar studies have performed: While there have been studies on smoking cessation methods, this specific approach focusing on nicotine salt concentrations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Bern
- Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Evangelia Liakoni, MD — Inselspital, Bern University Hospital
- Study coordinator: Evangelia Liakoni, MD
- Email: evangelia.liakoni@insel.ch
- Phone: 0041316325461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.