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

Phase 2

Recruiting

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

• Registration Number: DRKS00026758
• Lead Sponsor: Dräger Safety AG & Co. KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 56

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

- 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.