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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN95019245

Enrollment

1000

Registered

2009-05-05

Start date

2009-03-09

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking behaviour Mental and Behavioural Disorders Smoking Addiction

Interventions

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 subje

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026