Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette

Nicotine Use Disorder Clinical Trial

Official title:

Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine Administered by Electronic Cigarette and Cigarette

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511704
• Other study ID #: IMIMFTCL/CIG-E/1
• 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

• Nicotine Use Disorder
• Tobacco Use Disorder

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