Longitudinal study of long-term smoking behaviour by biomarker-supported determination of exposure to smoke

Abstract

BackgroundLong-term studies of smokers who switch to lower nicotine yield cigarettes have been identified by the World Health Organization Study Group TobReg and the US Food and Drug Administration as one key area where new knowledge is required to guide science based regulation. The limited number of long-term switching studies have concluded that smokers who switch to lower nicotine yield cigarettes show evidence of partial compensation. Since the European Union tobacco product directive of 2001 introduced tar and nicotine yield ceilings, there has been no long-term observational switching study. To address the limitations of previous studies where smokers were forced switched for relatively short durations, we plan to undertake a long-term study of spontaneous switching which is appropriately powered and includes non-switchers as a control group.Methods/designHealthy adult smokers aged 21–64 years will be enrolled into this 5-year non-residential, multicentre study across 10 cities in Germany. They will be assessed at 10 timepoints with 6 month intervals during which inclusion criteria will be reassessed and spent cigarette filter tips, saliva and 24 h urine samples will be collected. These samples will be used to determine average daily cigarette consumption, estimate mouth-level exposure to tar and nicotine and measure selected biomarkers of exposure, respectively. Spontaneous changes in subjects’ preferred cigarette products and any consequent change in tar or nicotine yield will be monitored. Subjects will be required to complete questionnaires on quality of life, smoking behaviours, smoking-related sensory attributes and recent life changes.DiscussionThe planned study is anticipated to contribute to understanding smokers’ behaviours and their consequent exposure to smoke constituents. It will also allow assessment of compensatory changes in their behaviour following spontaneous switching of cigarette product smoked. Data from this study are expected to provide insights into study design and conduct for non-clinical assessment of smokers’ exposure as part of post marketing surveillance programmes.Trial registrationCurrent Controlled Trials Database reference ISRCTN95019245.

Saliva Liquid Biopsy for Point-of-Care Applications

“…Furthermore, saliva may act as a monitoring tool, for example, to assess the levels of nicotine and cotinine in subjects who smoke (33, 34), to determine the possibility of drug abuse (35), and to excessive alcohol consumption (36). …”

“… Pharmacotherapy : saliva can also be utilized in monitoring therapeutic drug level and treatment responses, for example, in persons with epilepsy ( 32 ). Furthermore, saliva may act as a monitoring tool, for example, to assess the levels of nicotine and cotinine in subjects who smoke ( 33 , 34 ), to determine the possibility of drug abuse ( 35 ), and to excessive alcohol consumption ( 36 ). …”

Reference change values in concentrations of urinary and salivary biomarkers of exposure and mouth level exposure in individuals participating in an ambulatory smoking study

“…Full details of the study protocol have been described previously [27] . Briefly, all subjects were daily smokers of 8 cigarettes or more.…”

A longitudinal study of smokers’ exposure to cigarette smoke and the effects of spontaneous product switching

“…Subjects were required to provide written informed consent and were provided with details of local smoking advice centres. Full details of the study design, subject screening, and study visit activities and measurements are described by Cunningham et al (2014).…”