The purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
Electronic cigarettes (e-cigarettes) are battery-operated devices that deliver nicotine via inhaled vapour or "vaping". At present, e-cigarettes are becoming increasingly popular among smokers worldwide. However, knowledge about e-cigarette nicotine pharmacology remains limited. The aims of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
12
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.
Barcelona, Barcelona, Spain
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of nicotine and its metabolites in blood
Time frame: From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of nicotine and its metabolites in urine
Time frame: From baseline (pre-dose, 0h) to 55, 120 min, 6, 12 and 24h
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of nicotine and its metabolites in oral fluid
Time frame: From baseline (pre-dose, 0h) to 15, 30, 45, 55, 65, 75, 90, 105, 120 min, 6, 12 and 24h
Number of Participants with Serious and Non-Serious Adverse Events
Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
Time frame: 2 days after each substance administration
Elimination half-life
Calculation of elimination hal-life from concentrations of nicotine and its metabolites in plasma-blood, urine and oral fluid.
Time frame: From baseline to 24h post-dose
Changes in blood pressure
Measure of blood pressure (systolic and diastolic blood pressure)
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in heart rate
Measure of heart rate (pulse)
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Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in expired carbon monoxide (CO) aire
Measure of expired CO aire using a BreathCO monitor
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in pupil diameter
Measure of pupil diameter using a Haab pupil gauge
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in oral temperature
Measure of temperature in mouth using automatic thermometer
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in subjective effects
Subjective effects will be measured using rate scales (visual analogue scales) including measures of good effects and other feelings induced by nicotine
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in nicotine abstinence symptoms
Nicotine abstinence symptoms will be measured using rate scales (visual analogue scales) including items sensitive to nicotine effects
Time frame: From pre-dose (baseline) to 120 min post-dose