Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes
Condition: Tobacco Abuse Smoke
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

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.
    

Intervention name(s): Own Brand cigarette; one high 2,4% nicotine; original 7,4 mg nicotine; nicotine free; Ego 9mg
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Smoke, 15 puff of, Own Brand cigarettes;; Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine; Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine; smoke, 15 puff, of electronic cigarette nicotine free; smoke, 15 puff, of electronic cigarette Ego 9 mg
Other intervention name(s): 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
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic