The German Study on Tobacco Use
Organizational Data
- DRKS-ID:
- DRKS00028054
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-02-22
- Last update in DRKS:
- 2023-07-25
- Registration type:
- Prospective
Acronym/abbreviation of the study
DEBRA
URL of the study
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. ************** 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.
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.
Health condition or problem studied
- ICD10:
- F17.2
- Free text:
- Smoking behavior, nicotine dependence, use of tobacco products, and alternative nicotine delivery systems (e.g., e-cigarettes, tobacco heaters).
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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). *************** 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. ************** 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.
Endpoints
- 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.
- Secondary outcome:
- Secondary aim is to compare our primary endpoints with comparable data from other international surveys, particularly from England.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Cerner Enviza Deutschlandweit (Germany nationwide)
Recruitment period and number of participants
- Planned study start date:
- 2022-04-28
- Actual study start date:
- 2022-04-30
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 32000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 14 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Informed consent
Exclusion Criteria
barriers in language, moderate-severe cognitive impairment
Addresses
Primary Sponsor
- Address:
- Medical Faculty of the Heinrich-Heine-University DuesseldorfMoorenstr. 540225 DüsseldorfGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-UniversityUniv.-Prof. Dr. Daniel KotzPostfach 10100740001 DüsseldorfGermany
- Telephone:
- 0049 (0)211 / 81- 1 63 27
- Fax:
- 0049 (0)211 / 81 -1 87 55
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
Contact for Public Queries
- Address:
- Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-UniversityUniv.-Prof. Dr. Daniel KotzPostfach 10100740001 DüsseldorfGermany
- Telephone:
- 0049 (0)211 / 81- 1 63 27
- Fax:
- 0049 (0)211 / 81 -1 87 55
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
Principal Investigator
- Address:
- Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-UniversityUniv.-Prof. Dr. Daniel KotzPostfach 10100740001 DüsseldorfGermany
- Telephone:
- 0049 (0)211 / 81- 1 63 27
- Fax:
- 0049 (0)211 / 81 -1 87 55
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-duesseldorf.de/allgemeinmedizin
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Federal Ministry of Health (BMG) GermanyRochusstraße 153123 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der Medizinischen Fakultät der Heinrich-Heine-Universität DüsseldorfMoorenstr. 540225 DüsseldorfGermany
- Telephone:
- +49-211-8119591
- Fax:
- +49-211-8119592
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-01-14
- Ethics committee number:
- 5386R
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-01-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- 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.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00011322 - DRKS-ID Studienteil 1/study part 1
- DRKS00017157 - DRKS-ID Studienteil 2/study part 2
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- All publications can be found unter "Research" at the DEBRA website
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry