Smoking Research Study
The purpose of this study is to develop a fit-for-purpose biochemical verification tool that can be used to detect concomitant use of a few (less than 5) conventional cigarettes.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Single-centre, Dose Titration Study in Healthy Volunteers (Smokers and Non-smokers) to Evaluate the Capacity of 2-cyanoethylmercapturic Acid (CEMA) to Detect Low Level of Cigarette Smoking Exposure|
- Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour urine of smokers smoking 2 or 4 conventional cigarettes [ Time Frame: After smoking 2 or 4 conventional cigarettes, within 24 hours ] [ Designated as safety issue: No ]To demonstrate that CEMA, used as a urinary biomarker, can identify subjects who have smoked 4 or less conventional cigarettes
- Levels of CEMA in 24-hour urine, carboxyhaemoglobin (COHb) in blood and carbon monoxide in exhaled breath of smokers smoking 2 or 4 conventional cigarettes [ Time Frame: After smoking 2 or 4 conventional cigarettes, within 24 hours ] [ Designated as safety issue: No ]To evaluate the ability of CEMA to detect conventional cigarette use in comparison to COHb and exhaled carbon monoxide
- Levels of CEMA, a biomarker of exposure to acrylonitrile, in 24-hour and spot urine of non-smokers [ Time Frame: 24 hours ] [ Designated as safety issue: No ]To evaluate the correlation between the levels of CEMA in 24-hour urine and in spot urine in non-smokers
|Study Start Date:||July 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
No Intervention: Part B. Healthy Caucasian adult non-smokers
Experimental: Part A.Healthy Caucasian adult smokers
No product will be investigated in this study. Smokers will smoke their own conventional cigarettes only.
Other: Part A
Smoking abstinence, smoking 2 and 4 cigarettes
This study will be performed in two parts. The first part, Part A, is a dose titration study in healthy smokers with incremental cigarette consumption performed in confinement. The second part, Part B, is an observational study on healthy non-smokers in an ambulatory setting
PART A (smokers only)
A screening visit will be conducted within 4 weeks prior to admission to the investigational site. The 8-day confinement period consists of the admission day (Day1), 1 day ad-libitum smoking (Day0), 3 days of smoking abstinence (Day1-3), 2-day exposure period smoking 2 and 4 cigarettes (Day4-5), and the day of discharge (Day6) followed by a 7-day safety follow-up period. Urine collection will be performed for each subject from Day0 to Day5 in 4 intervals.
PART B (non-smokers)
Screening visit will be conducted within 4 weeks prior to the ambulatory Visit 1 (collection of 24-hour urine and spot urine) to the investigational site. The minimum interval between the screening and Visit 1 is of 7 days.
|Simbec Research Ltd|
|Merthyr Tydfil, South Wales, United Kingdom, CF48 4DR|
|Principal Investigator:||Salvatore Febbraro, MD||Simbec Research|