The requires a hair samples to determine the concentrations of nicotine and cotinine. Therefore,
Conditions
Interventions
Normal metabolizers,Slow metabolizers
People with 2 normal copies of the gene are called extensive metabolizers and are expected to respond normally to nicotine.,People with 1 or 2 reduced activity gene variant have reduced enzyme activit
Experimental Genetic,Experimental Genetic
Sponsors
the 90th Anniversary of Chulalongkorn University Fund (Ratchadaphiseksomphot Endowment Fund)
Clinical Pharmacokinetics Research Unit in Renal and Cardiovascular Disease
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Study I : Genotyping of CYP2A6 1. Thai smokers visiting medical check-up clinic at King Chulalongkorn Memorial Hospital 2. Age of smoker between 18-60 years 3. Current smoker and defined as smoking >100 cigarette at least 5 months determined by Fagerström Test for Nicotine Dependence (FTND) test 4. Written informed consent Study II : Pharmacokinetics of nicotine 1. Thai smoker had normal metabolizers (CYP2A6*1A/*1A, CYP2A6*1A/*1B, and CYP2A6*1B/*1B) or slow metabolizers (CYP2A6*1A/*4, CYP2A6*1A/*9, CYP2A6*1B/*9, CYP2A6*9/*9, CYP2A6*4/*4, CYP2A6*4/*9 and CYP2A6*1B/*4) 2. Abstain from smoking (tobacco and nicotine replacement therapy) for 12 hours prior to the study 3. Agree to keep the hair root from the back of scalp length of 5 centimeters and 100 milligram of hairs 4. Written informed consent
Exclusion criteria
Exclusion criteria: Study I : Genotyping of CYP2A6 1. Who had use medication within 14 days prior to the start of the study 2. Liver and kidney disease 3. During pregnancy or breast feeding 4. Participation in another clinical trial within 30 days Study II : Pharmacokinetics of nicotine 1. Who had use medication within 14 days prior to the start of the study 2. Liver and kidney disease 3. During pregnancy or breast feeding 4. Who had a history of temporomandibular joint disease or pain 5. Participation in another clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CYP2A6 genetic variation (Normal metabolizers and Slow metabolizers) at 6 months Restriction fragment length polymorphism method (PCR-RFLP) and Real-time PCR | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of nicotine and hair nicotine metabolites at 7 months Liquid chromatography tandem-mass spectrometry (LC-MS/MS) technique | — |
Countries
Thailand
Contacts
Public ContactPajaree Chariyavilaskul
Clinical Pharmacokinetics Research Unit in Renal and Cardiovascular Disease
Outcome results
None listed