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Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes (KINECIG)

This study has been completed.
Sponsor:
Collaborator:
Laboratory for Health Protection Research
Information provided by (Responsible Party):
Riccardo Polosa, Universita degli Studi di Catania
ClinicalTrials.gov Identifier:
NCT01665066
First received: July 23, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

The aim of the present study is to compare serum nicotine levels of different e-Cigarette strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be also compared.


Condition Intervention
Tobacco Abuse Smoke
 Other: Own Brand cigarette
Other: one high 2,4% nicotine
Other: original 7,4 mg nicotine
Other: nicotine free
Other: Ego 9mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes: a Randomised Cross-over Trial KINECIG

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Universita degli Studi di Catania:

Primary Outcome Measures:
  • nicotine pharmacokinetic [ Time Frame: 0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes ] [ Designated as safety issue: No ]
    participants will be cannulated and serial venous blood samples for Nicotine will be collected at 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10 puffs of cigarette


Secondary Outcome Measures:
  • Serum levels of carcinogenic and toxic substances (Aldehydes; ROM/TOS; Total thiols) [ Time Frame: 0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes ] [ Designated as safety issue: No ]
    Compare serum levels of carcinogenic and toxic substances of "Categoria" electronic cigarettes labelled Original 7,4 mg nicotine , Disposable "Categoria" electronic cigarettes labelled One 2,4% nicotine, Disposable "Categoria" electronic cigarettes labelled nicotine free, electronic cigarettes labelled Ego 9mg nicotine with usual cigarettes.


Enrollment: 15
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Own Brand cigarette
Smoke Own Brand cigarette, 15 puff of cigarette.
 Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine
Experimental: One High 2,4% nicotine
Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
 Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine
Experimental: Original 7,4 mg nicotine
Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
 Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine
Placebo Comparator: Nicotine Free
Smoke electronic cigarette nicotine free (15 puff)
 Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine
Experimental: EGO 9mg
Smoke electronic cigarette EGO for a day (15 puff)
 Other: Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
Other Name: Own Brand cigarette
Other: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Name: Categoria electronic cigarette one high 2,4% nicotine
Other: original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
Other Name: Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Name: categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Name: electronic cigarette Ego 9 mg nicotine

Detailed Description:

The study is randomised cross-over trial designed to compare: 1) serum nicotine levels of four different e-Cigarette strength ; 2) Serum levels of carcinogenic and toxic substances will be also compared. Participants will be requested to abstain from smoking and alcohol from 20:00 on the night before each study day and from food and caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide (CO) will be measured in participants' expired breath. If CO will be less than 15 parts per million (ppm), the assigned study treatment will be allocated; however, if CO was > 15 ppm or they will report smoking in the previous 12 h, participants will be rescheduled wherever possible to a subsequent session.

On the first study day, participants will be randomised to use one of five ordered conditions (each separated by 3 day): ENDDs (fourth generation) containing nicotine 2,4%; ENDDs (second generation) containing nicotine 7,4 mg; ENDDs containing nicotine 9 mg; ENDDs nicotine free; their usual cigarette. Additionally participants will be trained to use an electronic cigarette. The following tests will be completed at the each visits: Aldehydes; ROM/TOS; Total thiols; Nicotine; Hydroxypyrene; Cotinine; 1,3-butadiene; Acrylonitrile. After, they will be cannulated and serial venous blood samples for Aldehydes; ROM/TOS; Total thiols; Nicotine will be collected at 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10 puffs. Additionally, levels of carbon monoxide in exhaled breath (eCO) will be measured 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10 puffs. At 60 min, after being instructed to take 10 puffs, urine sample for Hydroxypyrene; Cotinine; 1,3-butadiene; Acrylonitrile will be collected. Participants then will leave the study centre with instructions to continue their usual daily activities and to use the study product regularly (for at least 10 hrs) and freely throughout the day. At bedtime and after the puffing chronic phase, when participants will use the study product regularly for at least 10 hrs, urine sample for Hydroxypyrene; Cotinine; 1,3-butadiene; Acrylonitrile will be collected. Participants will be allowed to smoke as they will wish once these measures will be collected and during the 3-day washout period between each study day.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, CO > 10 parts per million ) will be recruited from the local Hospital staff in Catania, Italy.

Exclusion Criteria:

  • people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and
  • pregnancy,
  • breastfeeding,
  • blood pressure > 180 mm Hg systolic and/or 100 mm Hg diastolic,
  • weight < 45 or > 120 kg, or
  • current use of any other smoking cessation medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665066

Locations
Italy
Centro per la Prevenzione e Cura del Tabagismo
Catania, Italy, 95124
Sponsors and Collaborators
Universita degli Studi di Catania
Laboratory for Health Protection Research
Investigators
Principal Investigator: Riccardo Polosa, MD, Phd University of Catania
  More Information

Publications:

Responsible Party: Riccardo Polosa, Professor of Internal Medicine, Universita degli Studi di Catania
ClinicalTrials.gov Identifier: NCT01665066     History of Changes
Other Study ID Numbers: KINECIG UNICT 526 /12 (Polosa), Polosa-Caponnetto 2012
Study First Received: July 23, 2012
Last Updated: December 12, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013