A single-center study designed to evaluate changes in short-term biomarkers of potential harm (BoPH) in healthy adult cigarette smokers of two age groups (Group A: 24-34 years; Group B: 35-60 years) during 14 days of smoking abstinence.
The overall goal of the smoking abstinence study is to discover and assess biomarkers that respond rapidly to smoking abstinence and explore whether the smokers' age influences the responsiveness of biomarkers to changes in smoking status. The study is a single-center, parallel cohort, in which generally healthy adult male and female smokers participated. Smokers of 10-30 cigarettes per day for at least 5 years prior to screening were recruited. Plasma and urine (24h and spot urine) samples and other biological specimens will be collected at the baseline and at specified timepoints during the course of the study. The study will include two primary study cohorts, smokers ages 24-34 years and 35-60 years, to determine whether age could be a confounder in the qualification of biomarkers. Starting on Day -2, eligible smokers will be confined at the clinical site for 17 days. Biological samples will be collected on Days -2 and -1 for baseline study endpoints. On Day 1, smokers will be switched to smoking abstinence for 14 days. Samples will be collected for endpoint analysis throughout the 14-day abstinence period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
70
Smokers will be switched to smoking abstinence for 14 days
Celerion Lincoln
Lincoln, Nebraska, United States
Urinary Arachidonic Acid (AA) Metabolites 2,3-dinor-thromboxane B2 (TxM) and leukotriene E4 (LTE4)
Change in Urinary Arachidonic Acid (AA) Metabolites TxM and LTE4
Time frame: 14 days
Urinary AA metabolites TxM and LTE4
Change in Urinary AA metabolites TxM and LTE4
Time frame: 7 days
Additional AA metabolites
Change in additional AA metabolites: Tetranor-prostaglandin (t-PGDM); Tetranor-prostaglandin E metabolite (t-PGEM); 2,3-dinor-8-iso prostaglandin F2alpha (2,3-d-8-iso-PGF2α); 8-iso prostaglandin F 2alpha (8-iso-PGF2α); Prostaglandin F 2alpha (PGF2α); 11-dehydrothromboxane B2 (11-dh-TXB2); 20-carboxy-leukotriene B4 (20-COOH-LTB4); 20-hydroxy-leukotriene B4 (20-OH-LTB4)
Time frame: 14 days
Biomarkers of Exposure in Urine: Nicotine equivalents and CEMA
Change in biomarkers of exposure in Urine: Nicotine equivalents (molar sum of nicotine + 5 metabolites); 2-cyanoethylmercapturic acid (CEMA)
Time frame: 14 days
Biomarkers of Exposure in Urine: TSNAs
Change in biomarkers of exposure in Urine: Tobacco Specific Nitrosamine(s) (TSNAs)
Time frame: 14 days
Biomarkers of Exposure in Blood: Carboxyhemoglobin
Change in biomarkers of exposure in Blood: Whole blood carboxyhemoglobin
Time frame: 14 days
Biomarkers of Exposure in Blood: nicotine and cotinine
Change in biomarkers of exposure in Blood: Plasma nicotine; Plasma cotinine
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Time frame: 14 days
Biomarkers of Potential Harm: FeNO
Change in biomarkers of potential harm: Fractional expired Nitric Oxide (FeNO)
Time frame: 14 days
Biomarkers of Potential Harm: ABG
Change in biomarkers of potential harm: Arterial Blood Gas (ABG)
Time frame: 14 days
Nasal Mucociliary Clearance (NMC) Saccharin Transit Time (STT)
Change in Nasal Mucociliary Clearance (NMC) Saccharin Transit Time (STT)
Time frame: 14 days
T- and B-lymphocytes and Natural Killer (NK) cell profiles
Change in T- and B-lymphocytes and Natural Killer (NK) cell profiles
Time frame: 14 days
Changes in Platelet Aggregation
Evaluation of platelet aggregation using Adenosine Diphosphate (ADP) as an agonist from baseline to Day 14. Platelet aggregation testing measures the ability of various agonists to platelets to induce ex vivo activation and platelet-to-platelet activation.
Time frame: 14 days