Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality

NCT ID: NCT06333457

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-03-30

Brief Summary

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Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.

Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.

Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET.

Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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VR group

50 patients with diagnosed alcohol dependence (in-patients, patients in the outpatient department or day clinics) receiving VR Cue-Exposure Therapy (VR-CET) additional to the standard treatment.

VR Cue-Exposure Therapy

Intervention Type DEVICE

Standard VR Cue Exposure Therapy (VR-CET) for the treatment of alcohol dependence

control group

50 patients with diagnosed alcohol dependence (in-patients, patients in the outpatient department or day clinics) receiving standard treatment.

No interventions assigned to this group

Interventions

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VR Cue-Exposure Therapy

Standard VR Cue Exposure Therapy (VR-CET) for the treatment of alcohol dependence

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age: 18-65 years
* diagnosis of alcohol dependence according to ICD-10 (F10.2)
* completed in-patient withdrawal treatment during the last 3 months
* history of alcohol craving, confrmed via craving questionnaires
* able to provide written informed consent

Exclusion Criteria

* substance dependence other than alcohol and nicotine
* current alcohol intoxication (randomly tested via measurement of breath alcohol concentration)
* unable to understand the study information, consent form or principles of the study
* abstinence for less than 7 days or on-going consumption of alcohol
* severe neuropsychiatric disorder, e.g., schizophrenia spectrum disorders, bipolar afective disorder or substantial cognitive impairment
* somatic diseases for which VR is associated with risks, e.g. photosensitive epilepsy
* acute suicidality or acute endangerment of others
* concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfram, naltrexone, nalmefene)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Alva Lütt

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EA4/024/24

Identifier Type: -

Identifier Source: org_study_id

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