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Randomized controlled trial to investigate the efficacy of the Draeger Companion med treatment unit for alcohol dependence.

Randomized controlled trial to investigate the efficacy of the Draeger Companion med treatment unit for alcohol dependence. - Dräger Companion med

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026758
Enrollment
56
Registered
2022-01-27
Start date
2022-06-14
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Mental and behavioural disorders due to use of alcohol : Dependence syndrome F10.2

Interventions

Group 1: Participants in the intervention group will receive the Dräger Companion med procedure pack for 6 months. Group 2: The control group has the same general conditions as the intervention group,

Sponsors

Dräger Safety AG & Co. KGaA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosed alcohol dependence according to ICD-10-GM F10.2 - Intention to stop alcohol consumption - Age = 18 years - Resident (registered primary residence) in the Federal Republic of Germany. - Willingness to participate in the study - Completed physical detoxification - Legal capacity

Exclusion criteria

Exclusion criteria: - Dependence on other psychotropic substances (except tobacco and caffeine) - Acute psychiatric illness requiring treatment or suicidality - Severe cognitive impairment - Abstinence has existed for longer than 6 weeks prior to baseline interview - Lack of German language skills - Acute concomitant illness at the time of individual study entry that requires short-term inpatient admission is required - Impairment of vision that prevents the intended use of the product prevented - Use of another app or web application for alcohol cessation or consumption control - Participation in another (non-digital) program for alcohol cessation or consumption control (current or in the past 3 months) - Existing dependent relationship with a person involved in the study - Members of vulnerable populations (e.g., incarcerated, pregnant, breastfeeding)

Design outcomes

Primary

MeasureTime frame
Self-reported alcohol abstinence rate 6 weeks after Study entry. The data on self-reported alcohol abstinence will be taken from the patients' drinking diaries.

Secondary

MeasureTime frame
1. objectively measured alcohol abstinence rate 6 weeks after the start of the intervention. 2. number of relapses 6 weeks after start of study 3. drinking-free days 6 weeks after start of study 4. amount of alcohol drunk 6 weeks after start of study 5. health-related quality of life 6 weeks after start of study 6. self-efficacy using AASE-G 6 weeks after baseline 7. physical functioning using 1-MSTST including Borg scale 6 weeks after baseline 8. self-reported alcohol abstinence rate 3 months after baseline 9. objectively measured alcohol abstinence rate 3 months after baseline 10. self-efficacy using AASE-G 3 months after baseline 11. physical functioning using 1-MSTST including Borg scale 3 months after baseline 12. self-reported alcohol abstinence rate 6 months after baseline 13. objectively measured alcohol abstinence rate 6 months after baseline 14. health-related quality of life 6 months after start of study 15. self-efficacy using AASE-G 6 months after baseline 16. physical functioning using 1-MSTST including Borg scale 6 months after baseline 17. self-reported alcohol abstinence rate 12 months after start of intervention 18. objectively measured alcohol abstinence rate 12 months after start of study 19. objectively measured alcohol abstinence rate 12 months after baseline 20. health-related quality of life 12 months after start of study 21. self-efficacy using AASE-G 12 months after baseline 22. physical functioning using 1-MSTST including Borg scale 12 months after baseline

Countries

Germany

Contacts

Public ContactKlaus Junghanns

Zentrum für Integrative Psychiatrie ZIP gGmbH

schlaflabor.zip.luebeck@uksh.de+4945150098092

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026