Concentration Impact Nicotine Salt

Smoking Cessation Clinical Trial

— CINS  

Official title:

Impact of the Nicotine Concentration on the Efficacy of a Nicotine Salt Vape Pod System as Smoking Cessation Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725656
• Other study ID #: BASEC-ID: 2020-01875
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Smoking Cessation
• Vaping

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