Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder

NCT07667790 | Not Yet Recruiting

• 1 other identifier: EA1/269/24_trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol use disorder (AUD) is a prevalent and burdensome clinical condition with high relapse rates. A central risk factor for relapse is craving for alcohol-often accompanied by an attentional bias toward alcohol-related stimuli-which can be evoked by both real-world and virtual stimuli 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 craving and attentional bias in patients with AUD. The goal of this prospective experimental single-arm clinical study, with a 2 (visual stimuli: neutral vs. alcohol-related VR scenarios) × 2 (olfactory stimuli: no odor vs. alcohol-related odor) within-subjects factorial design, is to determine how visual and olfactory stimuli contribute to the outcomes during a multimodal VR-CE in patients with AUD. The main question is whether VR-CE with concurrent visual and olfactory alcohol-related stimuli induces a greater increase in craving and attentional bias from baseline than exposure to a single modality (visual or olfactory), as assessed by subjective and psychophysiological measures in patients with AUD.

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorder; virtual reality cue exposure; olfactory

Outcome Measures

Primary Outcomes (1)

• Self-reported craving (VAS-C)

  Self-reported craving will be assessed using the visual analogue scale (VAS-C; range 0-10, higher score indicates higher levels of craving) during the 2 (visual) × 2 (olfactory) virtual reality cue exposure (VR-CE) conditions.

  Day 1, at minute 0:30, 2:30 and 4:30 during both VR baseline sessions and each VR-CE condition.

Secondary Outcomes (13)

• Psychophysiological craving index (heart rate variability, HRV)

  Day 1, continuously during both VR baseline sessions and each VR-CE condition.

• Psychophysiological craving index (heart rate, HR)

  Day 1, continuously during both VR baseline sessions and each VR-CE condition.

• Psychophysiological craving index (electrodermal activity, EDA)

  Day 1, continuously during both VR baseline sessions and each VR-CE condition.

• Psychophysiological craving index (respiratory rate, RR)

  Day 1, continuously during both VR baseline sessions and each VR-CE condition.

• Psychophysiological craving index (pupillometry)

  Day 1, continuously during both VR baseline sessions and each VR-CE condition.

Other Outcomes (6)

• Sociodemographic variables

  Day one, before VR-CE

• AUD characteristics (AUDIT)

  Day 1, before the VR-CE

• AUD characteristics (ADS)

  Day 1, before the VR-CE

Study Arms (1)

VR-CE

EXPERIMENTAL

The single-arm clinical study employs a 2 (visual: neutral vs. alcohol-related VR scenarios) × 2 (olfactory: no odor vs. alcohol-related odor) within-subjects factorial design. Each participant will complete all four conditions within the virtual reality cue exposure (VR-CE)

Device: VR-CE

Interventions

VR-CE DEVICE

Virtual reality cue exposure (VR-CE) using visual (neutral vs. alcohol-related VR scenarios) and olfactory (no odor vs. alcohol-related odor) stimuli conditions.

VR-CE

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 between 18-65 years
• diagnosis of alcohol dependence according to ICD-10 (F10.2)
• complete inpatient detoxification within the last three months
• history of alcohol craving
• capacity to provide written informed consent

You may not qualify if:

• substance dependences other than alcohol or nicotine
• current alcohol intoxication (tested by random breath-alcohol measurements)
• alcohol abstinence less than 7 days or on-going alcohol consumption
• severe neuropsychiatric disorder (e.g. schizophrenia-spectrum disorder, bipolar affective disorder or substantial cognitive impairment)
• severe medical conditions affecting brain or heart function that could influence the parameters under investigation
• acute suicidality or risk of harm to others
• current pharmacological treatment for alcohol dependence (e.g., benzodiazepines) or for craving (e.g., acamprosate, disulfiram, naltrexone, nalmefene)
• other medications that may have a significant influence on heart rate
• sinusitis, self-reported problems with smell, or lack of normosmia, assessed both subjectively and objectively
• limited ability to understand the study information, the consent form or the study procedures and principles

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, Berlin 10115

Berlin, State of Berlin, 10115, Germany

Location

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.

  Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, Berlin 10115

  PRINCIPAL INVESTIGATOR

• Stefan Gutwinski, Prof. Dr. med.

  Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, Berlin 10115

  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: Principal Investigator: Alva Lütt, Dr. med.,Psychiatric University Hospital Charité at St. Hedwig Hospital, 10115 Berlin, Germany

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

DE (1)