Alcohol Use DisorderNCT04858061
"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder
A study testing Virtual Reality Cue Exposure Therapy and Treatment-as-usual in people with Alcohol Use Disorder, run by University of Barcelona at 1 site in Spain.
Trial summary
Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Alcohol craving and anxiety are factors contributing to relapse, even after completion of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Virtual Reality Cue Exposure Therapy and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2018to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with moderate (4-5 diagnostic criteria) or severe (6 or more diagnostic criteria) AUD according to DSM-5
- Minimum 3 days abstinence before initial evaluation
Who cannot join
- severe cognitive impairment that could interfere with comprehension and completion of the task
- severe psychopathology (e.g. major depression, schizophrenia, dementia)
- opiate addiction
- epilepsy
- severe visual impairments
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder.
Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Alcohol craving and anxiety are factors contributing to relapse, even after completion of treatment. The current study aims to test the efficacy of a Virtual Reality Cue-Exposure Therapy (VR-CET) patients diagnosed with severe AUD, who made several failed attempts to cease alcohol drinking. It is expected that VR-CET is more efficient in reducing AUD symptomatology and preventing relapses than treatment-as-usual (TAU). 80 participants will be randomly assigned to experimental or control group. The experimental group will receive treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) over the course of five weeks. VR-CET booster sessions consist of exposure to preferred alcoholic beverages and alcohol-related contexts in a VR environment. Throughout the six VR-CET sessions, momentary anxiety and alcohol craving levels will be assessed. The control group will receive only treatment-as-usual (TAU).
Read the detailed description
The efficacy of VR Cue Exposure Therapy and Cognitive Behavioral Therapy will be investigated on 80 primarly diagnosed by AUD. Participants will be recruited from Hospital Clínico de Barcelona (Barcelona, Spain). They will be randomly assigned to two booster treatments: treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) versus only treatment as-usual (TAU).
Visuo-tactile and visuo-motor stimulation will be induced to participants to get illusory feelings of ownership over the virtual body. Then patients will be choosing their favorite beverages and favorite places to have drinks. During exposure to a specific beverage in VR, participants' olfactory sense will also be stimulated by pouring the beverage onto a cotton and making the participant smell.
- Virtual Reality-based Cue Exposure Therapy (CET-VR): the intervention will consist of 6 sessions (two per week) lasting approximately 50 minutes. Throughout the sessions, the patient will be exposed to an individualized hierarchy of different VR environments that simulate situations and stimuli related to alcohol consumption. During exposure, the level of craving and anxiety experienced by patients will be assessed using visual analog scales. Once the level of craving has decreased sufficiently (40% of the initial level) in a given situation, it will move to another of greater difficulty to complete the hierarchy. The objective of the intervention is to reduce the craving response of patients in these situations through habituation and extinction processes, so that the generalization of the responses learned during treatment to real situations reduces the risk of relapse.
- Treatment-as-usual (TAU): All participants received therapy on an individual and group basis. The primary therapeutic goal of TAU was to maintain abstinence from alcohol during and after treatment discharge. The treatment consisted of a combination of pharmacotherapy and psychotherapy. Pharmacotherapy generally included medication such as disulfiram, anxiolytics, and/or antidepressants. Individual and group therapy sessions were based on psychotherapeutic approaches like cognitive-behavioral therapy and motivational interviewing. Weekly groups included facilitated recovery-oriented discussions in an open-group format. The TAU groups met once or twice weekly for 1 hour and 30 minutes. Patients assigned to the TAU condition were administered two assessment sessions with a 4-5-week diference in-between.
The initial evaluation session will be approximately one hour. The same evaluation instruments with the same procedure will be implemented in the post-treatment session, once finished either virtual reality or cognitive-behavioral therapy.
- Conditions
- Alcohol Use Disorder
- Being tested
- Virtual Reality Cue Exposure Therapy, Treatment-as-usual
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Cue Exposure TherapyBehavioural
Exposure to alcohol-related cues within virtual environments
Treatment-as-usualBehavioural
Pharmacotherapy and psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual supplemented with virtual reality cue-exposure therapy | Experimental | Treatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET). Receives: Behavioral: Virtual Reality Cue Exposure Therapy |
| Treatment-as-usual | Active comparator | Only treatment-as-usual (TAU) Receives: Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Craving based on AUDIT
Change in Craving levels using the Alcohol Use Disorders Identification Test (AUDIT), with scores ranging from 0 to 40. Higher scores reflect higher levels of craving
Measured: pre-assessment
Change in Craving based on MACS
Change in Craving levels using the Multidimensional Alcohol Craving Scale (MACS), with scores ranging from 0 to 60. Higher scores reflect higher levels of craving
Measured: at pre-assessment and after 3 weeks
Change in Anxiety
Change in Anxiety levels using the State-Trait Anxiety Inventory (STAI), with scores ranging from 0 to 60. Higher scores reflect higher levels of anxiety
Measured: at pre-assessment and after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start15 Sep 2018
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Ministry of Health, Spain, Ministry of Education and Vocational Training, Spain
- Responsible party
- Principal investigator, Jose Gutierrez Maldonado, University of Barcelona
- Investigators
- José Gutiérrez Maldonado, Prof. Dr., Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858061
- Sponsor's protocol ID
- 2016I078
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder.
- ClinicalTrials.gov ID
- NCT04858061
- Acronym / sponsor ID
- 2016I078
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Ministry of Health, Spain, Ministry of Education and Vocational Training, Spain
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Alcohol craving and anxiety are factors contributing to relapse, even after completion of treatment. The current study aims to test the efficacy of a Virtual Reality Cue-Exposure Therapy (VR-CET) patients diagnosed with severe AUD, who made several failed attempts to cease alcohol drinking. It is expected that VR-CET is more efficient in reducing AUD symptomatology and preventing relapses than treatment-as-usual (TAU). 80 participants will be randomly assigned to experimental or control group. The experimental group will receive treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) over the course of five weeks. VR-CET booster sessions consist of exposure to preferred alcoholic beverages and alcohol-related contexts in a VR environment. Throughout the six VR-CET sessions, momentary anxiety and alcohol craving levels will be assessed. The control group will receive only treatment-as-usual (TAU).
Detailed description
The efficacy of VR Cue Exposure Therapy and Cognitive Behavioral Therapy will be investigated on 80 primarly diagnosed by AUD. Participants will be recruited from Hospital Clínico de Barcelona (Barcelona, Spain). They will be randomly assigned to two booster treatments: treatment-as-usual supplemented with 6 sessions of virtual reality cue-exposure therapy (TAU + VR-CET) versus only treatment as-usual (TAU).
Visuo-tactile and visuo-motor stimulation will be induced to participants to get illusory feelings of ownership over the virtual body. Then patients will be choosing their favorite beverages and favorite places to have drinks. During exposure to a specific beverage in VR, participants' olfactory sense will also be stimulated by pouring the beverage onto a cotton and making the participant smell.
- Virtual Reality-based Cue Exposure Therapy (CET-VR): the intervention will consist of 6 sessions (two per week) lasting approximately 50 minutes. Throughout the sessions, the patient will be exposed to an individualized hierarchy of different VR environments that simulate situations and stimuli related to alcohol consumption. During exposure, the level of craving and anxiety experienced by patients will be assessed using visual analog scales. Once the level of craving has decreased sufficiently (40% of the initial level) in a given situation, it will move to another of greater difficulty to complete the hierarchy. The objective of the intervention is to reduce the craving response of patients in these situations through habituation and extinction processes, so that the generalization of the responses learned during treatment to real situations reduces the risk of relapse.
- Treatment-as-usual (TAU): All participants received therapy on an individual and group basis. The primary therapeutic goal of TAU was to maintain abstinence from alcohol during and after treatment discharge. The treatment consisted of a combination of pharmacotherapy and psychotherapy. Pharmacotherapy generally included medication such as disulfiram, anxiolytics, and/or antidepressants. Individual and group therapy sessions were based on psychotherapeutic approaches like cognitive-behavioral therapy and motivational interviewing. Weekly groups included facilitated recovery-oriented discussions in an open-group format. The TAU groups met once or twice weekly for 1 hour and 30 minutes. Patients assigned to the TAU condition were administered two assessment sessions with a 4-5-week diference in-between.
The initial evaluation session will be approximately one hour. The same evaluation instruments with the same procedure will be implemented in the post-treatment session, once finished either virtual reality or cognitive-behavioral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual supplemented with virtual reality cue-exposure therapy | Experimental | Behavioral: Virtual Reality Cue Exposure TherapyTreatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET). |
| Treatment-as-usual | Active comparator | Behavioral: Treatment-as-usualOnly treatment-as-usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with moderate (4-5 diagnostic criteria) or severe (6 or more diagnostic criteria) AUD according to DSM-5
- Minimum 3 days abstinence before initial evaluation
Key exclusion criteria (6 listed)
- severe cognitive impairment that could interfere with comprehension and completion of the task
- severe psychopathology (e.g. major depression, schizophrenia, dementia)
- opiate addiction
- epilepsy
- severe visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Cue Exposure TherapyExposure to alcohol-related cues within virtual environments | Behavioural | Treatment-as-usual supplemented with virtual reality cue-exposure therapy |
| Treatment-as-usualPharmacotherapy and psychotherapy | Behavioural | Treatment-as-usual |
Primary outcome
Change in Craving based on AUDIT
Time frame: pre-assessment
Change in Craving levels using the Alcohol Use Disorders Identification Test (AUDIT), with scores ranging from 0 to 40. Higher scores reflect higher levels of craving
Change in Craving based on MACS
Time frame: at pre-assessment and after 3 weeks
Change in Craving levels using the Multidimensional Alcohol Craving Scale (MACS), with scores ranging from 0 to 60. Higher scores reflect higher levels of craving
Change in Anxiety
Time frame: at pre-assessment and after 3 weeks
Change in Anxiety levels using the State-Trait Anxiety Inventory (STAI), with scores ranging from 0 to 60. Higher scores reflect higher levels of anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Gutiérrez Maldonado, Prof. Dr. principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Cue Exposure Therapy and Treatment-as-usual in people with Alcohol Use Disorder, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Craving based on AUDIT (time frame: pre-assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.