Concentration Impact Nicotine Salt

Insel Gruppe AG, University Hospital Bern125 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

125

Conditions

Smoking Cessation Vaping

Interventions

Smoking cessation counselingPROCEDURE

Smoking cessation counseling at baseline, week 1, and week 4.

Open system vape device and nicotine salt e-liquidsOTHER

Ad libitum use of nicotine salt e-liquids during three months.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Inselspital

Bern, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Volume of e-liquid used (in terms of superiority)

Volume of e-liquid used when using low vs. high nicotine salt concentration e-liquids.

Time frame: 1 month

Secondary Outcomes

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

Time frame: 1 month

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

Time frame: 1 month

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

Time frame: 3 and 6 months

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

Data from ClinicalTrials.gov

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