Trial document




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  DRKS00028054

Trial Description

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Title

The German Study on Tobacco Use

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Trial Acronym

DEBRA

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URL of the Trial

https://www.debra-study.info

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Brief Summary in Lay Language

The DEBRA study had its first funding period from June 2016 to April 2019 (DRKS00011322; Funder: Ministry for Culture and Science of the State of North Rhine-Westphalia, MKW) with a focus on tobacco product use/smoking behavior in the population and its second funding period from March 2019 to February 2022 (DRKS00017157; Funder: Federal Ministry of Health, BMG) with a particular focus on alternative nicotine products (e.g., e-cigarettes, tobacco heaters). As of March 2022, the DEBRA study will be funded by the BMG for a further ~three years (March 2022 - January 2025) to ensure continuous monitoring of the use of tobacco and alternative nicotine products in Germany.

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Summary:

Tobacco use is associated with major individual and societal harms. It therefore remains important to continuously record consumption overall as well as to observe which personal characteristics are particularly strongly associated with consumption and whether/how strongly vulnerable groups of people are affected (especially adolescents). This will provide important clues for prevention strategies. The same applies to alternative nicotine products, such as e-cigarettes and tobacco heaters, which are used by an increasing number of adolescents and adults in Germany and of which new variants are currently and rapidly expanding the market. These products can pose both risks (health hazards, "gateway" to smoking) and opportunities ("harm reduction," support for smoking cessation). From a health policy perspective, it is therefore important to know whether these products are more likely to support or undermine tobacco control measures.

The DEBRA study consists of face-to-face houselhold interviews of representative samples of the German population aged 14 and over (approx. 2,000 persons per survey wave = every second month, with a total of 16 waves over a period of 3 years). The study aims to (1) measure the frequency of current and past use of tobacco and alternative nicotine delivery systems (e-cigarettes, tobacco heaters, hookah, nicotine pouches, chewing tobacco, and any novel products) in the population of Germany, (2) to record relevant patterns of use in detail and observe them over time, (3) to analyze associations between the use of tobacco, alternative nicotine delivery systems, and demographic and socioeconomic characteristics of consumers, and (4) to generate opinion surveys on these products.

Respondents who are current tobacco smokers (daily or occasional) or recent ex-smokers (<=12 months since smoking cessation) at baseline will be re-contacted by phone after six month (follow-up) and asked about the rates, duration and success of quit attempts (if so), triggers of quit attempts, exposure to health professionals' advice on quitting, and use of behavioural (medical counselling, group therapy) and pharmacological (nictoine replacement, drugs) cessation aids, including e-cigarettes.

The methodology of DEBRA is closely aligned to the Smoking Toolkit Study, which will allow international comparisons of data.

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Brief Summary in Scientific Language

The DEBRA study had its first funding period from June 2016 to April 2019 (DRKS00011322; Funder: Ministry for Culture and Science of the State of North Rhine-Westphalia, MKW) with a focus on tobacco product use/smoking behavior in the population and its second funding period from March 2019 to February 2022 (DRKS00017157; Funder: Federal Ministry of Health, BMG) with a particular focus on alternative nicotine products (e.g., e-cigarettes, tobacco heaters). As of March 2022, the DEBRA study will be funded by the BMG for a further ~three years (March 2022 - January 2025) to ensure continuous monitoring of the use of tobacco and alternative nicotine products in Germany.

**************

Summary:

Tobacco use is associated with major individual and societal harms. It therefore remains important to continuously record consumption overall as well as to observe which personal characteristics are particularly strongly associated with consumption and whether/how strongly vulnerable groups of people are affected (especially adolescents). This will provide important clues for prevention strategies. The same applies to alternative nicotine products, such as e-cigarettes and tobacco heaters, which are used by an increasing number of adolescents and adults in Germany and of which new variants are currently and rapidly expanding the market. These products can pose both risks (health hazards, "gateway" to smoking) and opportunities ("harm reduction," support for smoking cessation). From a health policy perspective, it is therefore important to know whether these products are more likely to support or undermine tobacco control measures.

The DEBRA study consists of face-to-face houselhold interviews of representative samples of the German population aged 14 and over (approx. 2,000 persons per survey wave = every second month, with a total of 16 waves over a period of 3 years). The study aims to (1) measure the frequency of current and past use of tobacco and alternative nicotine delivery systems (e-cigarettes, tobacco heaters, hookah, nicotine pouches, chewing tobacco, and any novel products) in the population of Germany, (2) to record relevant patterns of use in detail and observe them over time, (3) to analyze associations between the use of tobacco, alternative nicotine delivery systems, and demographic and socioeconomic characteristics of consumers, and (4) to generate opinion surveys on these products.

Respondents who are current tobacco smokers (daily or occasional) or recent ex-smokers (<=12 months since smoking cessation) at baseline will be re-contacted by phone after six month (follow-up) and asked about the rates, duration and success of quit attempts (if so), triggers of quit attempts, exposure to health professionals' advice on quitting, and use of behavioural (medical counselling, group therapy) and pharmacological (nictoine replacement, drugs) cessation aids, including e-cigarettes.

The methodology of DEBRA is closely aligned to the Smoking Toolkit Study, which will allow international comparisons of data.

In the course of an amendment, the Ethics Commission at the Medical Faculty of the Heinrich-Heine-University Duesseldor has approved the extension of the DEBRA study for another ~three years (March 2022-January 2025) on 06.12.2021.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

All participant-related data in anonymised form.
On application with analysis protocol and predefined objectives.
We use a "data sharing agreement".
Data are made available only to industry-independent scientists.

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Organizational Data

  •   DRKS00028054
  •   2022/02/22
  •   [---]*
  •   yes
  •   Approved
  •   5386R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   DRKS00011322   (DRKS-ID Studienteil 1/study part 1)
  •   DRKS00017157   (DRKS-ID Studienteil 2/study part 2)
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Health Condition or Problem studied

  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
  •   Smoking behavior, nicotine dependence, use of tobacco products, and alternative nicotine delivery systems (e.g., e-cigarettes, tobacco heaters).
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Interventions/Observational Groups

  •   All participants of the computer-assisted, face-to-face household survey:
    Over a period of ~3 years, every two months, a new sample of approximately 2,000 respondents aged 14 years and older will complete the survey (16 waves = approximately 32,000 respondents).

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    Smokers and recent ex-smokers (<=12 months) of these samples:
    Six months later, this group will answer detailed questions about rates, duration and success of quit attempts, exposure to health professionals' advice on quitting, and use of behavioural and pharmacological cessation aids, including electronic cigarettes.

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    Current or recent users of electronic inhalation products of these samples: This group will be asked in detail about their consumption behaviour, harm perception of these products, motivation for and experience with these electronic inhalation products.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Primary aim of the DEBRA study is to track key variables relating to patterns and trends of consumption of tabacco and electronic inhalation products (e.g., e-cigarettes, heat-not-burn products), tobacco smoking and quitting in Germany, and to provide such nationally representative data to inform tobacco control policies, cessation strategies, and future scientific studies. Data will be collected via computer-assisted household interviews at baseline. Current tobacco smokers and recent ex-smokers will be followed-up 6 months later.

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Secondary Outcome

Secondary aim is to compare our primary endpoints with comparable data from other international surveys, particularly from England.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2022/04/28
  •   32000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   no maximum age
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Additional Inclusion Criteria

Informed consent

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Exclusion Criteria

barriers in language, moderate-severe cognitive impairment

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Addresses

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    • Medical Faculty of the Heinrich-Heine-University Duesseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-University
    • Mr.  Univ.-Prof. Dr.  Daniel  Kotz 
    • Postfach 101007
    • 40001  Düsseldorf
    • Germany
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    • Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-University
    • Mr.  Univ.-Prof. Dr.  Daniel  Kotz 
    • Postfach 101007
    • 40001  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Federal Ministry of Health (BMG) Germany
    • Rochusstraße 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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