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

Alcohol Dependence Clinical Trial

— PRE-VR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333457
• Other study ID #: EA4/024/24
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
Germany	Psychiatric University Hospital Charité at St. Hedwig Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving	subjective craving for alcohol, measured with Visual Analogue Scales (VAS; 0 - 10 with higher scores indication higher craving levels)	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
Primary	Craving	subjective craving for alcohol, measured with Alcohol Urge Questionnaire (AUQ; scores ranging from 8-56, higher scores indicating higher craving levels)	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
Primary	Craving	subjective craving for alcohol, measured with Obsessive Compulsive Drinking Scale (OCDS, scores 0-56; higher scores indicating higher craving levels)	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
Secondary	Relapse rates	TLFB (timeline followback method) for assessment of individual's alcohol intake	both groups: follow up appointment after 6 weeks, follow up appointment after 12 weeks
Secondary	Quality of Life	Assessment of quality of life via WHOQOL-BREF questionnaire, 0-100% (higher scores indicating better quality of life)	both groups: assessment during appointment 1 and 6 and during follow up appointments after 6 and 12 weeks
Secondary	Motion Sickness	Assessment of VR motion sickness using the Simulator Sickness Questionnaire (SSQ; scores from 0-48, higher scores indicating more side effects)	VR group: pre and post VR exposure (6 appointments/6 weeks)
Secondary	Presence in VR	Igroup Presence Questionnaire (IPQ; score range from 0 to 84, with higher scores indicating more realistic perceptions)	VR group: post VR exposure (6 appointments/6 weeks)