Nicotine Use Disorder
Conditions
Keywords
Nicotine, Electronic cigarette, Cigarette
Brief summary
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.
Detailed description
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.
Interventions
DRUGNicotine
Multiple dose nicotine
Sponsors
Istituto Superiore di Sanità
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Understanding and accepting the study procedures and signing the informed consent. * Male adults volunteers (18-45 years old). * Clinical history and physical examination demonstrating no organic or psychiatric disorders. * The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically. * Present use of nicotine without serious adverse reactions. * Smokers ≥ 3 cigarettes/day.
Exclusion criteria
* Having suffered any cardiovascular and/or respiratory disease in the three months prior to the study start. * History of drug dependence (except for nicotine dependence). * Daily consumption \>4 standard units of ethanol. * Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session. * Having suffered any organic disease or major surgery in the three months prior to the study start. * Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 12 weeks. * History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs. * Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed. * Use of any drug or substance inhibitor of cytochrome P-450-1A6 (CYP1A6) (p.e. raloxifene, coumarins, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC 0-24h) | From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose | Calculation of AUC of the concentrations of nicotine and its metabolites in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | 2 days after each substance administration | Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators |
| Elimination half-life | From baseline to 24h post-dose | Calculation of elimination hal-life from concentrations of nicotine and its metabolites in plasma-blood, urine and oral fluid. |
| Changes in blood pressure | From pre-dose (baseline) to 120 min post-dose | Measure of blood pressure (systolic and diastolic blood pressure) |
| Changes in heart rate | From pre-dose (baseline) to 120 min post-dose | Measure of heart rate (pulse) |
| Area Under the Concentration-Time Curve (AUC 0-24h) | From baseline (pre-dose, 0h) to 55, 120 min, 6, 12 and 24h | Calculation of AUC of the concentrations of nicotine and its metabolites in urine |
| Changes in pupil diameter | From pre-dose (baseline) to 120 min post-dose | Measure of pupil diameter using a Haab pupil gauge |
| Changes in oral temperature | From pre-dose (baseline) to 120 min post-dose | Measure of temperature in mouth using automatic thermometer |
| Changes in subjective effects | From pre-dose (baseline) to 120 min post-dose | Subjective effects will be measured using rate scales (visual analogue scales) including measures of good effects and other feelings induced by nicotine |
| Changes in nicotine abstinence symptoms | From pre-dose (baseline) to 120 min post-dose | Nicotine abstinence symptoms will be measured using rate scales (visual analogue scales) including items sensitive to nicotine effects |
| Changes in expired carbon monoxide (CO) aire | From pre-dose (baseline) to 120 min post-dose | Measure of expired CO aire using a BreathCO monitor |
Countries
Spain
Outcome results
None listed