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Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes

NCT ID: NCT01665066

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Abuse Smoke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Own Brand cigarette

Smoke Own Brand cigarette, 15 puff of cigarette.

Group Type ACTIVE_COMPARATOR

Own Brand cigarette

Intervention Type OTHER

Smoke, 15 puff of, Own Brand cigarettes;

one high 2,4% nicotine

Intervention Type OTHER

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

original 7,4 mg nicotine

Intervention Type OTHER

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

nicotine free

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette nicotine free

Ego 9mg

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette Ego 9 mg

One High 2,4% nicotine

Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.

Group Type EXPERIMENTAL

Own Brand cigarette

Intervention Type OTHER

Smoke, 15 puff of, Own Brand cigarettes;

one high 2,4% nicotine

Intervention Type OTHER

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

original 7,4 mg nicotine

Intervention Type OTHER

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

nicotine free

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette nicotine free

Ego 9mg

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette Ego 9 mg

Original 7,4 mg nicotine

Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.

Group Type EXPERIMENTAL

Own Brand cigarette

Intervention Type OTHER

Smoke, 15 puff of, Own Brand cigarettes;

one high 2,4% nicotine

Intervention Type OTHER

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

original 7,4 mg nicotine

Intervention Type OTHER

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

nicotine free

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette nicotine free

Ego 9mg

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette Ego 9 mg

Nicotine Free

Smoke electronic cigarette nicotine free (15 puff)

Group Type PLACEBO_COMPARATOR

Own Brand cigarette

Intervention Type OTHER

Smoke, 15 puff of, Own Brand cigarettes;

one high 2,4% nicotine

Intervention Type OTHER

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

original 7,4 mg nicotine

Intervention Type OTHER

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

nicotine free

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette nicotine free

Ego 9mg

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette Ego 9 mg

EGO 9mg

Smoke electronic cigarette EGO for a day (15 puff)

Group Type EXPERIMENTAL

Own Brand cigarette

Intervention Type OTHER

Smoke, 15 puff of, Own Brand cigarettes;

one high 2,4% nicotine

Intervention Type OTHER

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

original 7,4 mg nicotine

Intervention Type OTHER

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

nicotine free

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette nicotine free

Ego 9mg

Intervention Type OTHER

smoke, 15 puff, of electronic cigarette Ego 9 mg

Interventions

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Own Brand cigarette

Smoke, 15 puff of, Own Brand cigarettes;

Intervention Type OTHER

one high 2,4% nicotine

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

Intervention Type OTHER

original 7,4 mg nicotine

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

Intervention Type OTHER

nicotine free

smoke, 15 puff, of electronic cigarette nicotine free

Intervention Type OTHER

Ego 9mg

smoke, 15 puff, of electronic cigarette Ego 9 mg

Intervention Type OTHER

Other Intervention Names

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Categoria electronic cigarette one high 2,4% nicotine Categoria electronic cigarette 7,4 mg nicotine categoria electronic cigarette nicotine free "mint". electronic cigarette Ego 9 mg nicotine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratory for Health Protection Research

UNKNOWN

Sponsor Role collaborator

Universita degli Studi di Catania

OTHER

Sponsor Role lead

Responsible Party

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Riccardo Polosa

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riccardo Polosa, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

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Centro per la Prevenzione e Cura del Tabagismo

Catania, Catania, Italy

Site Status

Countries

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Italy

References

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Goniewicz ML, Kuma T, Gawron M, Knysak J, Kosmider L. Nicotine levels in electronic cigarettes. Nicotine Tob Res. 2013 Jan;15(1):158-66. doi: 10.1093/ntr/nts103. Epub 2012 Apr 22.

Reference Type RESULT
PMID: 22529223 (View on PubMed)

Other Identifiers

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Polosa-Caponnetto 2012

Identifier Type: REGISTRY

Identifier Source: secondary_id

KINECIG UNICT 526 /12 (Polosa)

Identifier Type: -

Identifier Source: org_study_id