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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04725656
Other study ID # BASEC-ID: 2020-01875
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2024
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Insel Gruppe AG, University Hospital Bern
Contact Evangelia Liakoni, MD
Phone 0041316325461
Email evangelia.liakoni@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

At the clinic screening visit demographics, smoking (including the Fagerström Test for Cigarette Dependence (FTCD) Questionnaire) and medical history, concomitant medication, vital signs, body mass index (BMI) and exhaled carbon monoxide (CO) will be assessed, and a physical examination will be performed. Saliva samples will be collected for cotinine and nicotine metabolite ratio (NMR) measurement, urine samples for urinary anabasine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), nicotine metabolites, tobacco-specific nitrosamines (TSNA), and VOC, and blood samples for genotyping, steroid levels, blood lipids, creatinine, and glucose. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Smoking cessation counseling
Smoking cessation counseling at baseline, week 1, and week 4.
Other:
Open system vape device and nicotine salt e-liquids
Ad libitum use of nicotine salt e-liquids during three months.

Locations

Country Name City State
Switzerland Inselspital Bern

Sponsors (2)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

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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