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OpenTrials
Completed

NCT Number: NCT06333457

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, State of Berlin, 10115, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VR Cue-Exposure Therapy

Device

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

Primary outcomes

  1. Craving

    Time frame: VR-group: 6 appointments/6 weeks. Every appointment pre, during (approx. 20 min VR exposure) and post VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks

    subjective craving for alcohol, measured with Visual Analogue Scales (VAS; 0 - 10 with higher scores indication higher craving levels)

  2. Craving

    Time frame: VR-group: 6 appointments/6 weeks. Every appointment pre and post VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks

    subjective craving for alcohol, measured with Alcohol Urge Questionnaire (AUQ; scores ranging from 8-56, higher scores indicating higher craving levels)

  3. Craving

    Time frame: VR-group: 6 appointments/6 weeks. Every appointment pre VR exposure / control group: 6 appointments/6 weeks, measures once every appointment, both groups: follow up appointments after 6 weeks + after 12 weeks

    subjective craving for alcohol, measured with Obsessive Compulsive Drinking Scale (OCDS, scores 0-56; higher scores indicating higher craving levels)

Secondary outcomes

  1. Relapse rates

    Time frame: both groups: follow up appointment after 6 weeks, follow up appointment after 12 weeks

    TLFB (timeline followback method) for assessment of individual's alcohol intake

  2. Quality of Life

    Time frame: both groups: assessment during appointment 1 and 6 and during follow up appointments after 6 and 12 weeks

    Assessment of quality of life via WHOQOL-BREF questionnaire, 0-100% (higher scores indicating better quality of life)

  3. Motion Sickness

    Time frame: VR group: pre and post VR exposure (6 appointments/6 weeks)

    Assessment of VR motion sickness using the Simulator Sickness Questionnaire (SSQ; scores from 0-48, higher scores indicating more side effects)

  4. Presence in VR

    Time frame: VR group: post VR exposure (6 appointments/6 weeks)

    Igroup Presence Questionnaire (IPQ; score range from 0 to 84, with higher scores indicating more realistic perceptions)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: PRE-VR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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