Smoking Cessation Clinical Trial
— CINSOfficial 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.
Status | Recruiting |
Enrollment | 312 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | Swiss National Science Foundation |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 month | |
Primary | Volume of e-liquid used (in terms of superiority) | Volume of e-liquid used when using low vs. high nicotine salt concentration e-liquids. | 1 month | |
Secondary | 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 | 1 month | |
Secondary | 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 | 1 month | |
Secondary | 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 | 3 and 6 months | |
Secondary | 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 | 3 and 6 months | |
Secondary | Number of drop-outs | Through study completion | ||
Secondary | Time of dropping out | Through study completion | ||
Secondary | Urinary volatile organic compounds (VOC) | Change of non-nicotine toxicants (VOC) from baseline to 1 month and 3 months of nicotine salt use | 1 and 3 months | |
Secondary | Tobacco-specific nitrosamines (TSNA) | Change of non-nicotine toxicants (TSNA) from baseline to 1 month and 3 months of nicotine salt use | 1 and 3 months | |
Secondary | 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. | 1 and 3 months | |
Secondary | Respiratory symptoms | Checklist with specific questions regarding shortness of breath, wheezing, cough or phlegm | Up to 6 months | |
Secondary | Adverse events | Checklist with specific questions regarding presence or absence of nausea, sleep disturbance, throat/mouth irritation or other | Up to 6 months | |
Secondary | Total nicotine amount vaped | 1 and 3 months | ||
Secondary | Total volume of e-liquid consumed | 1 and 3 months | ||
Secondary | Steroid profiles | Steroid profiles in saliva, blood and urine | Baseline, 1, 3 and 6 months | |
Secondary | Number of cigarettes smoked per day among those who fail to quit | Through study completion |
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