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Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder (OLFA-VR)

21. června 2026 aktualizováno: Alva Lütt, Charite University, Berlin, Germany

Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving in Alcohol Dependence

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Sixty patients with AUD, treated in inpatient or outpatient psychiatric clinics, will be enrolled in the study. Participants will receive written and verbal information about the study, and written informed consent for participation will be obtained. A screening for eligibility will then be conducted. This will include, among other things, a history of craving and the confirmation of normosmia. Sociodemographic data, questionnaires on craving, AUD characteristics, and tendency for immersion, as well as potentially confounding variables and factors influencing physiological parameters, will be collected. Participants will then be asked to name a beverage of their choice (beer, red wine, white wine, vodka, or schnaps), which will be presented to them visually and olfactorily during the VR-CE.

Before exposure to the VR scenarios, participants will be familiarized with the VR headset. Eye tracking within the head-mounted display (HMD) will be calibrated, and participants will be allowed to acclimatize to the VR environment. Subsequently, participants will be exposed to each of the four VR-CE conditions for 5 minutes (neutral visual+no odor; neutral visual+alcohol-related odor; alcohol-related visual+no odor; and alcohol-related visual+alcohol-related odor) in randomized order. Randomization will be implemented such that the visual stimuli are presented in blocks (i.e., both neutral or both alcohol-related VR scenarios), while the olfactory stimuli (no odor vs. alcohol-related odor) are randomized within each visual block. Prior to each visual block, participants will undergo a 5-minute VR baseline session in a black virtual room with blue orientation lines, which will serve as the baseline for subjective and psychophysiological parameters.

During exposure, psychophysiological parameters and eye-tracking data will be recorded, self-reported craving will be assessed three times and sense of presence once during each VR-CE condition. After the exposure, questionnaires to assess self-reported craving, attentional bias, sense of presence, affective reaction and cybersickness will be administered.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: VR-CE
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)
Přístroj: VR-CE
Virtual reality cue exposure (VR-CE) using visual (neutral vs. alcohol-related VR scenarios) and olfactory (no odor vs. alcohol-related odor) stimuli conditions.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Self-reported craving (VAS-C)
Časové okno: Day 1, at minute 0:30, 2:30 and 4:30 during both VR baseline sessions and each VR-CE condition.
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Psychophysiological craving index (heart rate variability, HRV)
Časové okno: Day 1, continuously during both VR baseline sessions and each VR-CE condition.
For a multimodal craving measurement, heart rate variability (HRV) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Day 1, continuously during both VR baseline sessions and each VR-CE condition.
Psychophysiological craving index (heart rate, HR)
Časové okno: Day 1, continuously during both VR baseline sessions and each VR-CE condition.
For a multimodal craving measurement, heart rate (HR, in beats per minute (bpm)) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Day 1, continuously during both VR baseline sessions and each VR-CE condition.
Psychophysiological craving index (electrodermal activity, EDA)
Časové okno: Day 1, continuously during both VR baseline sessions and each VR-CE condition.
For a multimodal craving measurement, electrodermal activity (EDA, in microsiemens) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Day 1, continuously during both VR baseline sessions and each VR-CE condition.
Psychophysiological craving index (respiratory rate, RR)
Časové okno: Day 1, continuously during both VR baseline sessions and each VR-CE condition.
For a multimodal craving measurement, respiratory rate (RR) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Day 1, continuously during both VR baseline sessions and each VR-CE condition.
Psychophysiological craving index (pupillometry)
Časové okno: Day 1, continuously during both VR baseline sessions and each VR-CE condition.
For a multimodal craving measurement, pupillometry (pupil dilation in mm) will be assessed as a psychophysiological craving index during both VR baseline sessions and each VR-CE condition.
Day 1, continuously during both VR baseline sessions and each VR-CE condition.
Self-reported craving (AUQ)
Časové okno: Day 1, after both VR baseline sessions and each VR-CE condition.
In addition to the VAS-C during VR baseline and VR-CE conditions, self-reported craving will be assessed using the Alcohol Urge Questionnaire (AUQ, range: 0-42, higher score indicates higher levels of craving).
Day 1, after both VR baseline sessions and each VR-CE condition.
Self-reported attentional bias (AAS)
Časové okno: Day 1, after each VR-CE condition, except for the combination of neutral VR scenario and no odor.
The Alcohol Attention Scale (AAS, item-range: 0-10, higher scores indicate higher levels of attention) will be used to assess self-reported attention toward the sight and smell of alcohol, as well as thoughts about drinking during each VR-CE condition with at least one alcohol-related stimulus.
Day 1, after each VR-CE condition, except for the combination of neutral VR scenario and no odor.
Pupillometry indices of attentional bias
Časové okno: Day 1, during the alcohol-related VR scenario.
Pupillometry indices of attentional bias will be continuously assessed through gaze tracking via eye-tracking of alcohol-related and neutral stimuli during the alcohol-related VR scenario.
Day 1, during the alcohol-related VR scenario.
Sense of presence (VAS-P)
Časové okno: Day one, during both VR baseline sessions and each VR-CE condition (minute 4:35).
Self-report of sense of presence will be assessed using a visual analogue scale (VAS-P; range 0-10, higher score indicates higher levels of sense of presence).
Day one, during both VR baseline sessions and each VR-CE condition (minute 4:35).
Sense of presence (IPQ)
Časové okno: Day 1, after both VR baseline sessions and each VR-CE condition.
Self-report of sense of presence will be assessed after both VR baseline sessions and each VR-CE condition via the Igroup Presence Questionnaire (IPQ, range: 0-6, higher scores indicate higher sense of presence).
Day 1, after both VR baseline sessions and each VR-CE condition.
Affective reaction (SAM)
Časové okno: Day 1, after both VR baseline sessions and each VR-CE condition.
Affective reaction will be assessed non-verbally using the three-item Self-Assessment Manikin (SAM, range: -4-4, higher scores indicate stronger affective reaction).
Day 1, after both VR baseline sessions and each VR-CE condition.
Cybersickness (FMS)
Časové okno: Day 1, after both VR baseline sessions and each VR-CE condition.
Cybersickness during both VR baseline sessions and each VR-CE condition will be assessed using the Fast Motion Sickness Scale (FMS, range: 0-20, higher scores indicate higher cybersickness).
Day 1, after both VR baseline sessions and each VR-CE condition.
Cybersickness (VRSQ)
Časové okno: Day 1, after both VR baseline sessions and each VR-CE condition.
In addition to the FMS, the Virtual Reality Sickness Questionnaire (VRSQ, range: 0-27, higher score indicates higher cybersickness) will be used to assess self-reported cybersickness.
Day 1, after both VR baseline sessions and each VR-CE condition.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sociodemographic variables
Časové okno: Day one, before VR-CE
Sociodemographic variables will be assessed, e.g. age, gender, sex
Day one, before VR-CE
AUD characteristics (AUDIT)
Časové okno: Day 1, before the VR-CE
Alcohol use disorder (AUD) characteristics, such as AUD screening score (AUDIT, range: 0-40, higher score indicates greater likelihood of alcohol dependence) will be assessed.
Day 1, before the VR-CE
AUD characteristics (ADS)
Časové okno: Day 1, before the VR-CE
Alcohol use disorder (AUD) characteristics, such as addiction severity (Alcohol Dependence Scale, ADS, range: 1-47, higher score indicates greater alcohol dependance severity) will be assessed.
Day 1, before the VR-CE
Self-reported trait craving before VR-CE (OCDS)
Časové okno: Day 1, before VR-CE
Self-reported trait craving prior to VR-CE will be assessed using the Obsessive Compulsive Drinking Scale (OCDS, range: 0-40, higher scores indicate higher craving).
Day 1, before VR-CE
Self-reported trait craving before VR-CE (CAS-A)
Časové okno: Day 1, before VR-CE
Self-reported trait craving prior to VR-CE will be assessed using the Craving Automated Scale for Alcohol (CAS-A, range: 0-75, higher scores indicate higher craving).
Day 1, before VR-CE
Immersive tendencies (ITQ)
Časové okno: Day 1, before VR-CE
Participants ability to feel immersed or "present" in an environment will be assessed as a trait using the Immersive Tendencies Questionnaire (ITQ, range: 18-126, higher scores indicate higher immersive tendencies).
Day 1, before VR-CE

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Charite University, Berlin, Germany

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alva Lütt, Dr. med., Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, Berlin 10115
  • Vrchní vyšetřovatel: Stefan Gutwinski, Prof. Dr. med., Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, Berlin 10115

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. července 2027

Dokončení studie (Odhadovaný)

1. července 2027

Termíny zápisu do studia

První předloženo

22. května 2026

První předloženo, které splnilo kritéria kontroly kvality

21. června 2026

První zveřejněno (Aktuální)

25. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

25. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • EA1/269/24_trial

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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