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

NCT07388693 | Recruiting

• 1 other identifier: EA1/269/24_feasibility
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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. In 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. The 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.

Conditions

Alcohol Dependence

Keywords

Alcohol Dependence, Virtual Reality Cue Exposure, Olfactory

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assessment of Initial Clinical Efficacy of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure

  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

Study Arms (1)

Olfactory VR

EXPERIMENTAL

neutral and alcohol-related olfactory and visual stimuli in a Virtual Reality Cue Exposure

Device: VR Cue-Exposure Including Olfactory Stimuli

Interventions

VR Cue-Exposure Including Olfactory Stimuli DEVICE

Virtual Reality Cue Exposure (NCT05861843, NCT06333457)

Olfactory VR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: 18-65 years
• diagnosis of alcohol dependence according to ICD-10 (F10.2)
• history of alcohol craving
• able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Psychiatric University Hospital Charité at St. Hedwig Hospital

Berlin, State of Berlin, 10115, Germany

RECRUITING

MeSH Terms

Conditions

Alcoholism; Anosmia

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alva Lütt, Dr. med.

  Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus, 10115 Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Stefan Gutwinski, Prof. Dr. med.

  Psychiatrische Universitätsklinik der Charité im St. Hedwig Krankenhaus, 10115 Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadja Ruckser, M.Sc.

CONTACT

+49 30 838 67876; nadja.ruckser@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alva Lütt, Dr. med., Psychiatric University Hospital Charité at St. Hedwig Hospital, 10115 Berlin, Germany

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 5, 2026
• Study Start: March 7, 2026
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

DE (1)