Virtual Reality for Alcoholism

(HOME Trial)

Overseen By Brandon G Oberlin, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Psychotropic drugs

Must not be taking: Mu-opioid drugs

Disqualifiers: Unstable medical, Habitual drug, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 days

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual reality (VR) program designed to help individuals with alcohol use disorder (AUD) reduce alcohol consumption and maintain sobriety. The researchers aim to determine if the VR experience can encourage participants to focus on their future, make better long-term decisions, and choose delayed rewards over immediate ones. Participants will be divided into two groups: one will try the VR program, while the other will receive standard care for comparison. This trial suits those who have been sober for at least 14 days but no more than a year, are committed to recovery, and can understand English. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future treatments for AUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow the use of psychotropic drugs for substance use disorder (SUD) comorbidity. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this virtual reality intervention is safe for early recovering alcohol use disorder persons?

Research has shown that virtual reality (VR) is generally safe and well-received for treating alcohol use problems. For example, one study found that VR helped reduce alcohol cravings without major safety issues. Another study showed that people using VR therapy drank less alcohol compared to those receiving regular therapy, suggesting VR's effectiveness and safety.

While VR appears promising, some studies note that individuals may respond differently to it, meaning it might work better for some than others. However, no major side effects or safety problems have been reported. VR also provides a controlled and safe way to practice managing cravings and avoiding relapse.

In summary, evidence supports VR as a safe and potentially effective treatment option for reducing alcohol use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for treating alcoholism because it offers a unique, immersive approach that differs from traditional methods like medication and therapy. Unlike standard treatments, which typically involve counseling or medication to reduce cravings, VR creates a controlled environment where individuals can safely practice coping strategies and decision-making skills. This hands-on experience can help people better prepare for real-world situations that might trigger their alcohol use. Additionally, VR's engaging nature may increase patient motivation and adherence to treatment, potentially leading to better outcomes.

What evidence suggests that this virtual reality intervention is effective for reducing alcohol use?

Research has shown that virtual reality (VR) can help treat alcohol use disorder (AUD). Studies have found that VR can reduce alcohol cravings and serve as a valuable therapy component. In this trial, participants in the Virtual Reality arm will receive VR interventions, which may help manage cravings, especially for those who drink heavily in social settings. Additionally, combining VR with cognitive-behavioral therapy (CBT) has proven effective for treating AUD. These findings suggest that VR might help people with AUD drink less and maintain sobriety. ^{3 4 6 7 8}

Who Is on the Research Team?

Brandon G Oberlin, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals in early recovery from alcohol use disorder (AUD). Participants should be interested in using virtual reality as a tool to help with their recovery. Specific eligibility criteria are not provided, but typically these would include factors like age range, severity of AUD, and willingness to adhere to the study protocol.

Inclusion Criteria

I am committed to following my treatment and recovery plan.

I am taking medication for a substance use disorder and mental health issue.

Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit

Exclusion Criteria

I have problems with my sense of smell or taste.

Unstable medical disorders

Habitual drug use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a Virtual Reality intervention to test for efficacy in reducing alcohol use and increasing abstinence

2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 30-day and 6-month intervals

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

Researchers are testing if a novel virtual reality intervention can reduce alcohol consumption and increase abstinence among people recovering from AUD. They want to see if VR helps with identifying with one's future self, extending how far into the future they plan, and preferring rewards that come later rather than immediately.

How Is the Trial Designed?

Group I: Virtual Reality Experimental Treatment 1 Intervention

Participants in this arm will receive the following interventions: Virtual Reality Park Virtual Reality Avatar

Group II: Treatment As Usual Placebo Group 1 Intervention

Participants in this arm will receive the following interventions: Virtual Reality Park

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Virtual reality exposure therapy has shown promise in reducing cravings for individuals with alcohol use disorder, based on a systematic review of ten studies involving 377 participants, primarily adult men with an average age of 44.1 years.

The effectiveness of virtual reality therapy is influenced by the realism of the virtual environment, which can enhance self-efficacy and reduce automatic drinking behaviors, but further research is needed to confirm its efficacy, especially for patients with additional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality efficiency as exposure therapy for alcohol use: A systematic literature review. Nègre, F., Lemercier-Dugarin, M., Kahn-Lewin, C., et al.[2023]

Virtual reality (VR) therapy shows promise in reducing cravings and substance use in individuals with substance use disorder, particularly in studies focused on nicotine addiction.

While VR may help improve mood and anxiety symptoms, the results are mixed, indicating that more targeted interventions are needed to fully understand its efficacy in treating emotional dysregulation and enhancing treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of virtual reality therapies for substance use disorders: Impact on secondary treatment outcomes. Taubin, D., Berger, A., Greenwald, D., et al.[2023]

Virtual reality therapy (VRTP) significantly reduced alcohol cravings in patients with alcohol dependence after 10 sessions, showing its potential as an effective treatment adjunct.

The VRTP group exhibited greater changes in craving levels compared to healthy controls, indicating that VRTP could also help identify individuals at high risk for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative electroencephalographic (qEEG) correlates of craving during virtual reality therapy in alcohol-dependent patients. Lee, SH., Han, DH., Oh, S., et al.[2022]

Virtual reality (VR) shows potential as a novel treatment for substance use disorders (SUDs), helping patients manage cravings and reduce stress, with studies indicating it activates similar brain areas as substances do.

Despite promising results, the current VR applications for treating SUDs are primarily research-based and not widely available, highlighting the need for more rigorous studies to confirm their effectiveness and address accessibility issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Individuals With Substance Use Disorders. Worley, J.[2019]

Virtual reality therapy (VRT) was tested on 12 alcohol-dependent subjects over 10 sessions, showing a significant decrease in brain metabolism in areas associated with reward and regulation, indicating a potential therapeutic effect.

The study suggests that VRT may help correct neurobiological imbalances in the limbic system of individuals with alcohol dependence, making it a promising treatment option for managing alcohol addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Therapy for the Treatment of Alcohol Dependence: A Preliminary Investigation With Positron Emission Tomography/Computerized Tomography. Son, JH., Lee, SH., Seok, JW., et al.[2022]

Practitioners and researchers believe that Virtual Reality Therapy (VRT) could be a valuable addition to treating Substance Use Disorders (SUDs), as it offers safe and realistic exposure to triggering scenarios.

VRT is seen as beneficial for adults and those with mental health issues, with the potential to enhance therapy by allowing the inclusion of avatars and observing reactions, although risks like relapse and over-confidence need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Practitioners and Researchers on the Use of Virtual Reality in Treatments for Substance Use Disorders. Skeva, R., Gregg, L., Jay, C., et al.[2021]

Virtual reality exposure therapy for anxiety disorders is shown to be safe and effective, often matching the efficacy of traditional in-person exposure therapy.

The increasing availability of affordable virtual reality systems and the development of self-guided programs could significantly enhance access to treatment for anxiety disorders, potentially addressing mental health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Anderson, PL., Molloy, A.[2021]

Immersive virtual reality (IVR) treatments showed comparable improvements in upper limb activity and daily functioning in stroke patients when compared to conventional therapy (CT), indicating its potential as an effective rehabilitation tool.

Non-immersive virtual reality (NIVR) also provided similar benefits to CT for various physical and psychological outcomes, but IVR may offer additional advantages for upper limb training, suggesting that the type of VR used can influence treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Mediated Therapies for Stroke Rehabilitation: A Systematic Review and Meta-Analysis. Mugisha, S., Job, M., Zoppi, M., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11212355/

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Virtual reality efficiency as exposure therapy for alcohol use

This systematic review of the literature examines the effectiveness of virtual reality as exposure therapy for heavy social drinkers.

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frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1337898/full

Virtual Reality CBT for Alcohol Use Disorder Study

We demonstrated VR-CBT to be a feasible intervention for patients with AUD which supports continued investigations in a larger randomized clinical trial.

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VR Cue-Exposure for Alcohol Dependence in Rehabilitation

This study shows that craving induction through our VR-CE paradigm is feasible and well-tolerated by patients with AD in long-term rehabilitation.

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Virtual Reality in Alcohol Use Disorder Assessment & Treatment

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Due to its high ecological validity, virtual reality (VR) technology has emerged as a powerful tool for mental health research.

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Virtual Reality Therapy (VRT) In Addiction Treatment

It provides individuals with a safe space to practice addiction coping strategies and relapse prevention techniques in a controlled environment.

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Virtual Reality in Prevention and Treatment of Substance ...

VR shows promise in addressing substance-related disorders, particularly for alcohol and nicotine. However, substantial heterogeneity in VR ...