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Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence 20 Real-World Evidence Virtual

Not yet recruiting
Clinical Trial NCT07388693 is an interventional study for Alcohol Dependence and is currently not yet recruiting. Enrollment is planned to begin on February 1, 2026 and continue until the study accrues 20 participants. Led by Charite University, Berlin, Germany, this study is expected to complete by May 31, 2026. The latest data from ClinicalTrials.gov was last updated on February 25, 2026.
Brief Summary
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 syst...Show More
Detailed Description
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 I...Show More
Official Title

Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence

Conditions
Alcohol Dependence
Other Study IDs
  • EA1/269/24
NCT ID Number
NCT07388693
Start Date (Actual)
2026-02-01
Last Update Posted
2026-02-25
Completion Date (Estimated)
2026-05-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Alcohol Dependence, Virtual Reality Cue Exposure, Olfactory
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalOlfactory VR
neutral and alcohol-related olfactory and visual stimuli in a Virtual Reality Cue Exposure
VR Cue-Exposure Including Olfactory Stimuli
Virtual Reality Cue Exposure (NCT05861843, NCT06333457)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
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
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
Tolerability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
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)
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
Acceptability of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
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
Day 1, after each VR-CE: question regarding technical functionality Day 1, after completion of all VR-CEs: UEQ, semi-structured interview
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Assessment of Initial Clinical Efficacy of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure
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)
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • age: 18-65 years
  • diagnosis of alcohol dependence according to ICD-10 (F10.2)
  • history of alcohol craving
  • able to provide written informed consent

  • hyposmia
  • dependence on substances other than alcohol and nicotine
  • current alcohol intoxication (randomly tested by 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 ongoing consumption of alcohol
  • severe neuropsychiatric disorder (e.g. schizophrenia spectrum disorders, bipolar affective disorder) or substantial cognitive impairment
  • serious illnesses affecting brain or heart function that influence physiological study parameters
  • acute suicidality (or acute endangerment of others)
  • concurrent pharmacological treatment targeting AUD (e.g. benzodiazepines) or craving (e.g. acamprosate, disulfiram, naltrexone, nalmefene) and further medication significantly influencing heart rate
Charite University, Berlin, Germany logoCharite University, Berlin, Germany
Study Responsible Party
Alva Lütt, Principal Investigator, Alva Lütt, Dr. med., Psychiatric University Hospital Charité at St. Hedwig Hospital, 10115 Berlin, Germany, Charite University, Berlin, Germany
Study Central Contact
Contact: Nadja Ruckser, M.Sc., +49 30 838 67876, [email protected]
1 Study Locations in 1 Countries

State of Berlin

Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, State of Berlin, 10115, Germany