Clinical trial NCT04725656: Concentration Impact Nicotine Salt
Official title: Impact of the Nicotine Concentration on the Efficacy of a Nicotine Salt Vape Pod System as Smoking Cessation Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Vaping
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2021-01-27
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

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
* 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

Primary outcomes:
measure: 7-day point prevalence tobacco abstinence (in terms of non-inferiority)
timeFrame: 1 month
measure: Volume of e-liquid used (in terms of superiority)
timeFrame: 1 month
Secondary outcomes:
measure: 7-day point prevalence tobacco cigarette abstinence
timeFrame: 1 month
measure: Continuous tobacco cigarette abstinence
timeFrame: 1 month
measure: 7-day point prevalence tobacco cigarette abstinence
timeFrame: 3 and 6 months
measure: Continuous tobacco cigarette abstinence
timeFrame: 3 and 6 months
measure: Number of drop-outs
timeFrame: Through study completion
measure: Time of dropping out
timeFrame: Through study completion
measure: Urinary volatile organic compounds (VOC)
timeFrame: 1 and 3 months
measure: Tobacco-specific nitrosamines (TSNA)
timeFrame: 1 and 3 months
measure: Liking/rating of trial product (active arms)
timeFrame: 1 and 3 months
measure: Respiratory symptoms
timeFrame: Up to 6 months
measure: Adverse events
timeFrame: Up to 6 months
measure: Total nicotine amount vaped
timeFrame: 1 and 3 months
measure: Total volume of e-liquid consumed
timeFrame: 1 and 3 months
measure: Steroid profiles
timeFrame: Baseline, 1, 3 and 6 months
measure: Number of cigarettes smoked per day among those who fail to quit
timeFrame: Through study completion
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Evangelia Liakoni, MD
role: PRINCIPAL_INVESTIGATOR
References: