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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02511704
Other study ID # IMIMFTCL/CIG-E/1
Secondary ID
Status Completed
Phase Phase 1
First received July 28, 2015
Last updated July 28, 2015
Start date October 2014
Est. completion date December 2014

Study information

Verified date December 2014
Source Parc de Salut Mar
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
Nicotine
Multiple dose nicotine
Nicotine
Multiple dose nicotine

Locations

Country Name City State
Spain Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar. Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Parc de Salut Mar Istituto Superiore di Sanità

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Concentration-Time Curve (AUC 0-24h) Calculation of AUC of the concentrations of nicotine and its metabolites in blood From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose No
Secondary Area Under the Concentration-Time Curve (AUC 0-24h) Calculation of AUC of the concentrations of nicotine and its metabolites in urine From baseline (pre-dose, 0h) to 55, 120 min, 6, 12 and 24h No
Secondary Area Under the Concentration-Time Curve (AUC 0-24h) Calculation of AUC of the concentrations of nicotine and its metabolites in oral fluid From baseline (pre-dose, 0h) to 15, 30, 45, 55, 65, 75, 90, 105, 120 min, 6, 12 and 24h No
Secondary 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 2 days after each substance administration Yes
Secondary Elimination half-life Calculation of elimination hal-life from concentrations of nicotine and its metabolites in plasma-blood, urine and oral fluid. From baseline to 24h post-dose No
Secondary Changes in blood pressure Measure of blood pressure (systolic and diastolic blood pressure) From pre-dose (baseline) to 120 min post-dose No
Secondary Changes in heart rate Measure of heart rate (pulse) From pre-dose (baseline) to 120 min post-dose No
Secondary Changes in expired carbon monoxide (CO) aire Measure of expired CO aire using a BreathCO monitor From pre-dose (baseline) to 120 min post-dose No
Secondary Changes in pupil diameter Measure of pupil diameter using a Haab pupil gauge From pre-dose (baseline) to 120 min post-dose No
Secondary Changes in oral temperature Measure of temperature in mouth using automatic thermometer From pre-dose (baseline) to 120 min post-dose No
Secondary 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 From pre-dose (baseline) to 120 min post-dose No
Secondary Changes in nicotine abstinence symptoms Nicotine abstinence symptoms will be measured using rate scales (visual analogue scales) including items sensitive to nicotine effects From pre-dose (baseline) to 120 min post-dose No
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