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

December 12, 2012 updated by: Riccardo Polosa, Universita degli Studi di Catania

Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes: a Randomised Cross-over Trial KINECIG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95124
        • Centro per la Prevenzione e Cura del Tabagismo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • 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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • 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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • 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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • 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: one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
Other Names:
  • 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 Names:
  • Categoria electronic cigarette 7,4 mg nicotine
Other: nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
Other Names:
  • categoria electronic cigarette nicotine free "mint".
Other: Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg
Other Names:
  • electronic cigarette Ego 9 mg nicotine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nicotine pharmacokinetic
Time Frame: 0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes
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
0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita degli Studi di Catania

Collaborators

Laboratory for Health Protection Research

Investigators

  • Principal Investigator: Riccardo Polosa, MD, Phd, University of Catania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (ESTIMATE)

August 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KINECIG UNICT 526 /12 (Polosa)
  • Polosa-Caponnetto 2012 (REGISTRY: Kinecig (Polosa-Caponnetto) 2012)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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