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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

July 23, 2012
December 12, 2012
May 2012
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01665066 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Tobacco Abuse Smoke
  • 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
  • Active Comparator: Own Brand cigarette
    Smoke Own Brand cigarette, 15 puff of cigarette.
    Interventions:
    • Other: Own Brand cigarette
    • Other: one high 2,4% nicotine
    • Other: original 7,4 mg nicotine
    • Other: nicotine free
    • Other: Ego 9mg
  • Experimental: One High 2,4% nicotine
    Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
    Interventions:
    • Other: Own Brand cigarette
    • Other: one high 2,4% nicotine
    • Other: original 7,4 mg nicotine
    • Other: nicotine free
    • Other: Ego 9mg
  • Experimental: Original 7,4 mg nicotine
    Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
    Interventions:
    • Other: Own Brand cigarette
    • Other: one high 2,4% nicotine
    • Other: original 7,4 mg nicotine
    • Other: nicotine free
    • Other: Ego 9mg
  • Placebo Comparator: Nicotine Free
    Smoke electronic cigarette nicotine free (15 puff)
    Interventions:
    • Other: Own Brand cigarette
    • Other: one high 2,4% nicotine
    • Other: original 7,4 mg nicotine
    • Other: nicotine free
    • Other: Ego 9mg
  • Experimental: EGO 9mg
    Smoke electronic cigarette EGO for a day (15 puff)
    Interventions:
    • Other: Own Brand cigarette
    • Other: one high 2,4% nicotine
    • Other: original 7,4 mg nicotine
    • Other: nicotine free
    • Other: Ego 9mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01665066
KINECIG UNICT 526 /12 (Polosa), Polosa-Caponnetto 2012
No
Riccardo Polosa, Universita degli Studi di Catania
Universita degli Studi di Catania
Laboratory for Health Protection Research
Principal Investigator: Riccardo Polosa, MD, Phd University of Catania
Universita degli Studi di Catania
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP