Clinical trial NCT02511704: Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette
Official title: Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine Administered by Electronic Cigarette and Cigarette
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nicotine Use Disorder
Keywords: Nicotine
Electronic cigarette
Cigarette
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
First posted: 2015-07-30
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Area Under the Concentration-Time Curve (AUC 0-24h)
timeFrame: From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose
Secondary outcomes:
measure: Area Under the Concentration-Time Curve (AUC 0-24h)
timeFrame: From baseline (pre-dose, 0h) to 55, 120 min, 6, 12 and 24h
measure: Area Under the Concentration-Time Curve (AUC 0-24h)
timeFrame: From baseline (pre-dose, 0h) to 15, 30, 45, 55, 65, 75, 90, 105, 120 min, 6, 12 and 24h
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 2 days after each substance administration
measure: Elimination half-life
timeFrame: From baseline to 24h post-dose
measure: Changes in blood pressure
timeFrame: From pre-dose (baseline) to 120 min post-dose
measure: Changes in heart rate
timeFrame: From pre-dose (baseline) to 120 min post-dose
measure: Changes in expired carbon monoxide (CO) aire
timeFrame: From pre-dose (baseline) to 120 min post-dose
measure: Changes in pupil diameter
timeFrame: From pre-dose (baseline) to 120 min post-dose
measure: Changes in oral temperature
timeFrame: From pre-dose (baseline) to 120 min post-dose
measure: Changes in subjective effects
timeFrame: From pre-dose (baseline) to 120 min post-dose
measure: Changes in nicotine abstinence symptoms
timeFrame: From pre-dose (baseline) to 120 min post-dose
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.
Study officials:
affiliation: Parc de Salut Mar
name: Magi Farre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: