Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:33 AM
Study NCT ID:
NCT07388693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D000086582', 'term': 'Anosmia'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure', 'timeFrame': 'Day 1, after each Virtual Reality Cue Exposure (VR-CE): questions regarding olfactory stimuli identification, olfactory perception of intensity, realism and congruence Day 1, after completion of all VR-CEs and assessments: dropout', 'description': 'Questions regarding olfactory stimuli identification, olfactory perception of intensity (0=imperceptible-100=intensely perceptible), realism (0=unrealistic-100=realistic) and congruence with visual stimuli (0=incongruous-100=congruous), higher scores reflect higher feasibility; dropout'}, {'measure': 'Tolerability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure', 'timeFrame': 'Day 1, before the start of the Virtual Reality Cue Exposures (VR-CE): SAM, PANAS, FMS, SSQ Day 1, after each VR-CE: questions regarding tolerability, SAM, FMS Day 1, after completion of all VR-CEs: SAM, PANAS, FMS, SSQ', 'description': 'Questions regarding tolerability of the technology and olfactory stimuli (0=unpleasant-100=pleasant), higher scores reflect higher tolerability Emotional side effects: Self-Assessment Manikin (SAM; valence, arousal and dominance, range -8 to 8 in steps of 2; -8=happy/tense/submissive feeling, 0=neither happy/tense/submissive nor unhappy/calm/submissive, 8=unhappy/calm/submissive) and Positive and Negative Affect Schedule (PANAS; positive affect: range 10-50, higher score reflects higher levels of positive affect; negative affect: range 10-50, lower score reflects lower levels of negative affect) Physical side effects (cybersickness): Fast Motion Sickness Scale (FMS; range 0-20, higher score reflects higher levels of cybersickness) and Simulator Sickness Questionnaire (SSQ; total score, range 0-48, higher score reflects more sickness; nausea factor, 0-27 range, higher score reflects more nausea; oculomotor factor, range 0-21, higher score reflects more oculomotor problems)'}, {'measure': 'Acceptability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure', 'timeFrame': 'Day 1, after each VR-CE: question regarding technical functionality Day 1, after completion of all VR-CEs: UEQ, semi-structured interview', 'description': 'Question regarding technical functionality User experience: User Experience Questionnaire (UEQ; pragmatic quality, hedonic quality and overall scale: range -3 to +3, -3=most negative, 0=neutral, +3=most positive answer) Semi-structured interview including overall impression, perceived usefulness of the integration of olfactory stimuli into Virtual Reality Cue Exposure (VR-CE), perceived willingness to use, open-ended feedback'}], 'secondaryOutcomes': [{'measure': 'Assessment of Initial Clinical Efficacy of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure', 'timeFrame': 'Day 1, before the start of the Virtual Reality Cue Exposures (VR-CE), after each VR-CE and after completion of all VR-CEs: VAS craving and presence Day 1, after completion of all VR-CE: Semi-structured interview', 'description': 'Craving: Visual Analogue Scale (VAS; range 0-10, higher score represents higher levels of craving) Semi-structured interview including perceived craving Presence: Visual Analogue Scale (VAS; range 0-10, higher score represents higher levels of presence)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol Dependence, Virtual Reality Cue Exposure, Olfactory'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'Alcohol dependence (AD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol, which can be evoked by both real-world and virtual cues in immersive Virtual Reality (VR). In addition to visual and auditory stimuli, olfactory stimuli are increasingly recognized as important for creating realistic, multisensory VR environments. However, no systematic investigation has yet examined how olfactory stimuli embedded in VR-based Cue Exposure (VR-CE) influence cue-elicited craving. As part of the OLFA-VR (Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving in Alcohol Dependence) research project, the present feasibility study aims to evaluate the feasibility, tolerability and acceptability of implementing olfactory stimuli into VR-CE.\n\nIn addition, this study not only examines the general feasibility of alcohol-related olfactory stimuli in VR-CE but also explores which specific alcohol-related olfactory stimuli prove to be feasible.\n\nThe investigators hypothesize that implementing olfactory stimuli into VR-CE will be feasible and tolerable for patients with AD, with no preventable serious side effects caused by VR-CE. The investigators also hypothesize that VR-CE will induce craving in most patients.', 'detailedDescription': 'Twenty patients with alcohol dependence (AD), treated in an inpatient or outpatient psychiatric clinic, will be included in the study. Participants will receive written and verbal information about the study and informed consent for participation will be obtained. A screening for eligibility will then be conducted. Sociodemographic data will be collected, and screening for harmful alcohol use (Alcohol Use Disorders Identification Test, AUDIT) and assessment of AD severity (Alcohol Dependence Scale, ADS) will be performed.\n\nParticipants will be exposed to two types of Virtual Reality (VR) scenarios combined with corresponding olfactory stimuli: a neutral VR scenario with neutral visual and olfactory stimuli (rose), and an alcohol-related VR scenario with alcohol-related visual and olfactory stimuli (beer, white wine, red wine, vodka, schnaps). The VR-CE protocol comprises one exposure to the neutral VR-CE followed by five alcohol-related VR-CEs. The five alcohol-related VR-CEs will be presented in a randomized order, each pairing a visual stimuli with the corresponding olfactory stimuli for a specific beverage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18-65 years\n* diagnosis of alcohol dependence according to ICD-10 (F10.2)\n* history of alcohol craving\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* hyposmia\n* dependence on substances other than alcohol and nicotine\n* current alcohol intoxication (randomly tested by 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 ongoing consumption of alcohol\n* severe neuropsychiatric disorder (e.g. schizophrenia spectrum disorders, bipolar affective disorder) or substantial cognitive impairment\n* serious illnesses affecting brain or heart function that influence physiological study parameters\n* acute suicidality (or acute endangerment of others)\n* concurrent pharmacological treatment targeting AUD (e.g. benzodiazepines) or craving (e.g. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart rate'}, 'identificationModule': {'nctId': 'NCT07388693', 'briefTitle': 'Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence', 'orgStudyIdInfo': {'id': 'EA1/269/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olfactory VR', 'description': 'neutral and alcohol-related olfactory and visual stimuli in a Virtual Reality Cue Exposure', 'interventionNames': ['Device: VR Cue-Exposure Including Olfactory Stimuli']}], 'interventions': [{'name': 'VR Cue-Exposure Including Olfactory Stimuli', 'type': 'DEVICE', 'description': 'Virtual Reality Cue Exposure (NCT05861843, NCT06333457)', 'armGroupLabels': ['Olfactory VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10115', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Psychiatric University Hospital Charité at St. Hedwig Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Nadja Ruckser, M.Sc.', 'role': 'CONTACT', 'email': 'nadja.ruckser@charite.de', 'phone': '+49 30 838 67876'}], 'overallOfficials': [{'name': 'Alva Lütt, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus, 10115 Berlin, Germany'}, {'name': 'Stefan Gutwinski, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus, 10115 Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Alva Lütt, Dr. med., Psychiatric University Hospital Charité at St. Hedwig Hospital, 10115 Berlin, Germany', 'investigatorFullName': 'Alva Lütt', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}