Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes

Tobacco Abuse Smoke Clinical Trial

— KINECIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665066
• Other study ID #: KINECIG UNICT 526 /12 (Polosa)
• Secondary ID: Polosa-Caponnett
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: December 12, 2012
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Universita degli Studi di Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tobacco Abuse Smoke
• Tobacco Use Disorder

Intervention

Other:
• Own Brand cigarette
Smoke, 15 puff of, Own Brand cigarettes;
• one high 2,4% nicotine
Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
• original 7,4 mg nicotine
Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
• nicotine free
smoke, 15 puff, of electronic cigarette nicotine free
• Ego 9mg
smoke, 15 puff, of electronic cigarette Ego 9 mg

Locations

Country	Name	City	State
Italy	Centro per la Prevenzione e Cura del Tabagismo	Catania

Sponsors (2)

Lead Sponsor	Collaborator
Universita degli Studi di Catania	Laboratory for Health Protection Research

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nicotine pharmacokinetic	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	No
Secondary	Serum levels of carcinogenic and toxic substances (Aldehydes; ROM/TOS; Total thiols)	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	No