| NCT ID | NCT04725656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2025-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility 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 *