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

Not Applicable

Completed

Conditions: Smoking behaviour
Mental and Behavioural Disorders
Smoking Addiction

Registration Number: ISRCTN95019245

Lead Sponsor: British American Tobacco (Investments) Ltd (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1000

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.

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To track the following every six months over a five year period: <br>1. Spontaneous switching from 10 mg ISO tar cigarette to other cigarettes with different ISO tar yields, assessed by telephone interviews <br>2. Mouth level exposure, assessed by part filter analysis <br>3. Smoking behaviour <br>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

Name	Time	Method
To track the following every six months over a five year period: <br>1. Compensatory smoking behaviour, assessed by published formula <br>2. Levels of additional biomarkers/metabolites in urine when validated methods are available in future