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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question\[s\] this trial aims to answer are: Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.

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 data supports the effectiveness of virtual reality therapy for alcoholism?

Research shows that virtual reality therapy can help reduce cravings and increase self-control in people with alcohol use disorder. It provides a realistic environment that helps patients practice resisting triggers, which can lead to better outcomes in managing their alcohol use. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating substance use disorders, including alcoholism?

Virtual reality therapy is generally considered safe for treating substance use disorders, including alcoholism, as long as risks like relapse and trauma are managed. It has been used safely in treating anxiety disorders and phobias, and practitioners believe it can be safely integrated into substance use disorder treatments. ^{1 2 6 7 8}

How is Virtual Reality Therapy different from other treatments for alcoholism?

Virtual Reality Therapy is unique because it uses immersive environments to expose patients to realistic scenarios that trigger cravings, helping them manage their responses in a controlled setting. This approach can enhance self-efficacy and reduce automatic drinking behaviors, offering a personalized and insightful experience not typically available in traditional therapies. ^{1 2 4 5 6}

Research Team

Brandon G Oberlin, PhD

Principal Investigator

Indiana University

Eligibility Criteria

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.

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

English comprehension

Exclusion Criteria

I have problems with my sense of smell or taste.

Unstable medical disorders

Habitual drug use

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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) 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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Views of Practitioners and Researchers on the Use of Virtual Reality in Treatments for Substance Use Disorders. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Virtual reality efficiency as exposure therapy for alcohol use: A systematic literature review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Computer-Mediated Therapies for Stroke Rehabilitation: A Systematic Review and Meta-Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Therapy for the Treatment of Alcohol Dependence: A Preliminary Investigation With Positron Emission Tomography/Computerized Tomography. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Quantitative electroencephalographic (qEEG) correlates of craving during virtual reality therapy in alcohol-dependent patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of virtual reality therapies for substance use disorders: Impact on secondary treatment outcomes. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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