A five year non-residential multi-centre observational study conducted to track any changes in mouth level exposure and salivary and urinary biomarkers from healthy smokers smoking in their normal environment

ISRCTN	ISRCTN95019245
DOI	https://doi.org/10.1186/ISRCTN95019245
Protocol serial number	N/A
Sponsor	British American Tobacco (Investments) Ltd (UK)
Funder	British American Tobacco

Submission date: 22/04/2009
Registration date: 05/05/2009
Last edited: 16/06/2015

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chris Proctor
Scientific

Chief Scientific Officer
British American Tobacco (Investments) Ltd
GR&D Centre
Regent's Park Road
Southampton
SO15 8TL
United Kingdom

Phone	+44 (0)2380 588279
Email	christopher_proctor@bat.com

Dr Stephan de la Motte
Scientific

Chief Medical Officer
Harrison Clinical Research Deutschland GmbH
Albrechtstr. 14
Muenchen
80636
Germany

Study information

Primary study design	Observational
Study design	Longitudinal non-residential multi-centre observational study
Secondary study design	Longitudinal study
Study type	Participant information sheet
Scientific title	Longitudinal study on long-term smoking habits using biomarker-supported determination of exposure to smoke
Study objectives	If subjects switch between factory made cigarettes with different International Organization for Standardization (ISO) tar yields, there should be a measurable difference in the levels of mouth level exposure, urinary / salivary biomarkers, and daily cigarette consumption.
Ethics approval(s)	Ethics Committee of Bayerischen Landesaerztekammer, 04/07/2008, ref: 08036
Health condition(s) or problem(s) studied	Smoking behaviour
Intervention	08/03/2013: Please note that this study was stopped in December 2012. The five year longitudinal study is ongoing at ten sites. Approximately 1,000 smokers (100 per site) will be enrolled. All subjects will be screened to rule out medical problems. Healthy smokers may get enrolled in the study on the day of screening or as per their convenience. Study subjects are instructed to perform the following activities during 12 days every 6 months: Day 1 (Visit 1): Visit Investigator site for informed consent and undergo screening Days 2-8: Collection of all their smoked cigarettes in their routine day-to-day environment Day 9 (Visit 2): Visit test location to receive study supply including cigarettes, filter cutter, 2 L polyethylene bottles for urine collection. Smokers will be instructed about filter collection and 24 hour urine collection procedures. Smokers will continue collection of their smoked cigarettes. Accountability of smoked cigarettes collected from Days 2-8. Day 10: Continue collection of smoked cigarettes. Receive telephonic instructions for activities to be performed on Day 11 Day 11: Smokers begin the collection of part filters from all cigarettes smoked as provided on Day 9. Smokers also begin collection of urine passed from the morning excluding the first void, into the urine bottles provided. Day 12 (Visit 3): Completion of 24 hour urine collection including the first void of Day 12. Part filter collection is also completed which would be the last cigarette smoked prior to taking the first void of Day 12. Smokers will visit the Investigator site between 3.00-9.00 pm, for collection of spot saliva sample and questionnaire administration. Collection of part filters and urine from Day 11 and 12 and unsmoked cigarettes are returned. Accountability of smoked cigarettes collected from Days 9-10. Telephone interview will be conducted to check the inclusion and exclusion criteria of all participants prior to study assessments.
Intervention type	Other
Primary outcome measure(s)	To track the following every six months over a five year period: 1. Spontaneous switching from 10 mg ISO tar cigarette to other cigarettes with different ISO tar yields, assessed by telephone interviews 2. Mouth level exposure, assessed by part filter analysis 3. Smoking behaviour 4. Levels of biomarkers in urine (nicotine, cotinine, trans-3'-hydroxycotinine, nicotine-N-glucuronide, cotinine-N-glucuronide, trans-3'-hydroxycotinine-O-glucuronide) and saliva (cotinine and trans-3'-hydroxycotinine)
Key secondary outcome measure(s)	To track the following every six months over a five year period: 1. Compensatory smoking behaviour, assessed by published formula 2. Levels of additional biomarkers/metabolites in urine when validated methods are available in future
Completion date	09/03/2014
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1000
Key inclusion criteria	1. Healthy males and females aged between 21 and 64 years of age who currently smoke the same 10 mg ISO tar cigarettes. If female, subjects will be non-pregnant and non-lactating. 2. Smokers who have been smoking 10 mg ISO tar product for more than 6 months and regularly smoke >=8 cigarettes per day 3. Subjects will have given their written informed consent to participate in the study Note: Study participants will independently purchase their cigarettes for personal use. The sponsor will only provide cigarettes for Days 9-11 as stated in the Interventions field.
Key exclusion criteria	1. Subjects with an existing chronic disease 2. Participated in a different investigation on smoking behaviour within the last 6 months 3. Subjects who are currently trying to quit smoking 4. Subjects who as part of their jobs are involved in public relations or advertising for the tobacco industry, the sales or manufacture of tobacco goods, or their immediate family
Date of first enrolment	09/03/2009
Date of final enrolment	09/03/2014

Locations

Countries of recruitment

United Kingdom
England
Germany

Study participating centre

British American Tobacco (Investments) Ltd

Southampton
SO15 8TL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	12/04/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes