Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 7:17 AM
Study NCT ID:
NCT06333457
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presence and Relapse Rates in Patients with Alcohol Use Disorder Using Virtual Reality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-03-23', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Craving', 'timeFrame': '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', 'description': 'subjective craving for alcohol, measured with Visual Analogue Scales (VAS; 0 - 10 with higher scores indication higher craving levels)'}, {'measure': 'Craving', 'timeFrame': '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', 'description': 'subjective craving for alcohol, measured with Alcohol Urge Questionnaire (AUQ; scores ranging from 8-56, higher scores indicating higher craving levels)'}, {'measure': 'Craving', 'timeFrame': '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', 'description': 'subjective craving for alcohol, measured with Obsessive Compulsive Drinking Scale (OCDS, scores 0-56; higher scores indicating higher craving levels)'}], 'secondaryOutcomes': [{'measure': 'Relapse rates', 'timeFrame': 'both groups: follow up appointment after 6 weeks, follow up appointment after 12 weeks', 'description': "TLFB (timeline followback method) for assessment of individual's alcohol intake"}, {'measure': 'Quality of Life', 'timeFrame': 'both groups: assessment during appointment 1 and 6 and during follow up appointments after 6 and 12 weeks', 'description': 'Assessment of quality of life via WHOQOL-BREF questionnaire, 0-100% (higher scores indicating better quality of life)'}, {'measure': 'Motion Sickness', 'timeFrame': 'VR group: pre and post VR exposure (6 appointments/6 weeks)', 'description': 'Assessment of VR motion sickness using the Simulator Sickness Questionnaire (SSQ; scores from 0-48, higher scores indicating more side effects)'}, {'measure': 'Presence in VR', 'timeFrame': 'VR group: post VR exposure (6 appointments/6 weeks)', 'description': 'Igroup Presence Questionnaire (IPQ; score range from 0 to 84, with higher scores indicating more realistic perceptions)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': '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.\n\nStudy group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with alcohol dependence treated in the inpatient or outpatient psychiatric clinics or day clinics of the Psychiatric University Hospital Charité at St. Hedwig-Hospital/ Department of Psychiatry and Neurosciences Campus Charité Mitte/ Theodor-Wenzel Werk Berlin / Jüdisches Krankenhaus Berlin / Vivantes Auguste-Viktoria-Klinikum', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18-65 years\n* diagnosis of alcohol dependence according to ICD-10 (F10.2)\n* completed in-patient withdrawal treatment during the last 3 months\n* history of alcohol craving, confrmed via craving questionnaires\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* substance dependence other than alcohol and nicotine\n* current alcohol intoxication (randomly tested via measurement of breath alcohol concentration)\n* unable to understand the study information, consent form or principles of the study\n* abstinence for less than 7 days or on-going consumption of alcohol\n* severe neuropsychiatric disorder, e.g., schizophrenia spectrum disorders, bipolar afective disorder or substantial cognitive impairment\n* somatic diseases for which VR is associated with risks, e.g. photosensitive epilepsy\n* acute suicidality or acute endangerment of others\n* concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfram, naltrexone, nalmefene)'}, 'identificationModule': {'nctId': 'NCT06333457', 'acronym': 'PRE-VR', 'briefTitle': 'Presence and Relapse Rates in Patients with Alcohol Use Disorder Using Virtual Reality', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Presence and Relapse Rates in Patients with Alcohol Use Disorder Using Virtual Reality', 'orgStudyIdInfo': {'id': 'EA4/024/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VR group', 'description': '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.', 'interventionNames': ['Device: VR Cue-Exposure Therapy']}, {'label': 'control group', 'description': '50 patients with diagnosed alcohol dependence (in-patients, patients in the outpatient department or day clinics) receiving standard treatment.'}], 'interventions': [{'name': 'VR Cue-Exposure Therapy', 'type': 'DEVICE', 'description': 'Standard VR Cue Exposure Therapy (VR-CET) for the treatment of alcohol dependence', 'armGroupLabels': ['VR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10115', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alva Lütt, Dr. med.', 'role': 'CONTACT', 'email': 'alva.luett@charite.de', 'phone': '03023110'}], 'facility': 'Psychiatric University Hospital Charité at St. Hedwig Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Alva Lütt', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}