Condition category
Mental and Behavioural Disorders
Date applied
22/04/2009
Date assigned
05/05/2009
Last edited
16/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chris Proctor

ORCID ID

Contact details

Chief Scientific Officer
British American Tobacco (Investments) Ltd
GR&D Centre
Regent's Park Road
Southampton
SO15 8TL
United Kingdom
+44 (0)2380 588279
christopher_proctor@bat.com

Type

Scientific

Additional contact

Dr Stephan de la Motte

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Longitudinal study on long-term smoking habits using biomarker-supported determination of exposure to smoke

Acronym

Study hypothesis

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

Ethics Committee of Bayerischen Landesaerztekammer, 04/07/2008, ref: 08036

Study design

Longitudinal non-residential multi-centre observational study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a Subject Information Sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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)

Secondary outcome measures

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

Overall trial start date

09/03/2009

Overall trial end date

09/03/2014

Reason abandoned

Objectives no longer viable

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,000 smokers

Participant 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

Recruitment start date

09/03/2009

Recruitment end date

09/03/2014

Locations

Countries of recruitment

Germany

Trial participating centre

British American Tobacco (Investments) Ltd
Southampton
SO15 8TL
United Kingdom

Sponsor information

Organisation

British American Tobacco (Investments) Ltd (UK)

Sponsor details

GR&D Centre
Regent's Park Road
Southampton
SO15 8TL
United Kingdom
+44 (0)2380 793715
christopher_proctor@bat.com

Sponsor type

Industry

Website

http://www.bat-science.com

Funders

Funder type

Industry

Funder name

British American Tobacco

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24725994

Publication citations

Additional files

Editorial Notes