Virtual Reality Intervention for Opioid Use Disorder

(PARK Trial)

No longer recruiting at 2 trial locations

Overseen By Colton M Lind, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Indiana University

Must be taking: Psychotropic drugs

Disqualifiers: Unstable medical, psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual reality (VR) intervention to aid individuals in early recovery from opioid use disorder. Researchers aim to determine if VR can reduce opioid use, extend periods of abstinence, and enhance future-oriented thinking. Participants will be divided into two groups: one will use the Virtual Reality Avatar Intervention, while the other will use a simulated version. The trial seeks individuals who have abstained from opioids for at least 14 days but not more than a year, are committed to recovery, and can understand English. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on psychotropic drugs for substance use disorder (SUD) comorbidity and mu-opioid drugs, suggesting you might not need to stop these medications.

What prior data suggests that this virtual reality intervention is safe for individuals with opioid use disorder?

Research shows that virtual reality (VR) treatments are generally safe and easy to manage. Past studies have used VR to address substance use problems without major safety issues. Most participants find VR experiences comfortable and engaging. Side effects, such as nausea or dizziness, are rare and typically mild. VR's use in other healthcare areas further supports its safety. While this specific VR treatment for opioid use disorder is still under evaluation, past research suggests it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality Avatar Intervention for opioid use disorder because it offers a fresh, immersive approach to treatment. Unlike traditional methods like medication-assisted therapy or counseling, this intervention uses virtual reality to create a personalized experience for users, potentially making therapy more engaging and relatable. By providing a virtual environment where participants can interact with avatars, it aims to enhance emotional connection and motivation, which could lead to better treatment outcomes. This innovative approach taps into the power of technology to support recovery in a way that traditional treatments do not.

What evidence suggests that this virtual reality intervention is effective for opioid use disorder?

Research has shown that virtual reality (VR) might help reduce opioid use. A small study found VR beneficial for people with opioid use disorder (OUD). In this trial, one group will receive the Virtual Reality Avatar Intervention, which researchers have examined for its impact on cravings, emotions, and brain activity related to addiction. This suggests VR might help individuals avoid opioids and concentrate on future goals. Meanwhile, the control group will receive Sham VR as a comparator. Although more research is necessary, these early results offer hope that VR could become a valuable tool in recovery. ^{1 2 5 6 7}

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 aged 18-60 who are in early recovery from opioid use disorder, having been abstinent for at least 14 days but not more than 6 months. They must be committed to recovery, able to understand English, and can take psychotropic drugs if needed for SUD-related conditions. People cannot join if they've used drugs or alcohol within the last 24 hours before the study visit.

Inclusion Criteria

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

I am not currently hospitalized.

Use of psychotropic drugs for SUD-comorbidity

Exclusion Criteria

Unstable psychiatric conditions

Presence of extravagant/elaborate face tattoos

I have problems with my sense of smell or taste.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VR intervention to test its efficacy in reducing opioid use and increasing abstinence

4 weeks

1 visit (in-person) for VR intervention

Follow-up

Participants are monitored for changes in opioid use, abstinence, and future orientation at the 30-day follow-up

4 weeks

1 visit (in-person) at 30-day follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Avatar Intervention
• Virtual Reality Empty Park

Trial Overview

The trial is testing a new virtual reality (VR) intervention against a control group with no VR exposure. It aims to see if VR can help reduce opioid use and increase abstinence periods over a month follow-up by enhancing future-oriented thinking and preference for delayed rewards among participants.

How Is the Trial Designed?

Group I: Virtual Reality Experimental Treatment 2 Interventions

Participants in this arm will receive the following interventions: Virtual Reality Avatar VR plus Treatment As Usual (Intervention)

Group II: Sham VR (Control) Placebo Group 1 Intervention

Participants in this arm will receive the following interventions: Sham VR plus Treatment As Usual (Empty Virtual Reality Park)

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

Approved in United States as Virtual Reality Avatar Intervention for:

• Substance Use Disorder
• Opioid Use Disorder

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Digital therapeutics, such as virtual reality apps, have been authorized by the FDA as effective treatments for chronic conditions like low back pain and can enhance the effectiveness of traditional medications like buprenorphine for opioid use disorder.

A review of randomized controlled trials showed that patients using digital interventions alongside opioid treatments generally reported better pain relief compared to those receiving standard care, highlighting the potential of these technologies in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunct Digital Interventions Improve Opioid-Based Pain Management: Impact of Virtual Reality and Mobile Applications on Patient-Centered Pharmacy Care. Giravi, HY., Biskupiak, Z., Tyler, LS., et al.[2022]

Virtual Reality (VR) technology shows promise in both assessing cravings and treating substance use disorders, providing high ecological validity in its applications.

While VR effectively provokes cravings across various addictions, treatment outcomes based solely on virtual exposure to drug-related cues have shown mixed results, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality (VR) in Assessment and Treatment of Addictive Disorders: A Systematic Review. Segawa, T., Baudry, T., Bourla, A., et al.[2020]

Digital interventions for treating opioid use disorder, including methods like mobile apps and video conferencing, were found to be generally acceptable and satisfactory to participants, with 10 out of 20 studies showing significant improvements in opioid abstinence.

The effectiveness of these digital interventions varied, with some studies demonstrating better treatment retention, highlighting the need for further research to explore their impact in diverse populations, especially in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for opioid use disorder treatment: A systematic review of randomized controlled trials. Kiburi, SK., Ngarachu, E., Tomita, A., et al.[2023]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

In a study involving 20 stroke survivors, multiuser virtual reality (MU VR) therapy led to significantly greater arm movement (414.6m) compared to single-user (SU VR) therapy (327.0m), indicating that MU VR may enhance physical engagement during rehabilitation.

Participants showed high compliance with both therapy modes (99% for MU and 89% for SU), and overall motor recovery, as measured by the Fugl-Meyer Assessment, improved significantly across all participants, suggesting that MU VR can effectively extend clinical therapy into home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Thielbar, KO., Triandafilou, KM., Barry, AJ., et al.[2020]

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]

A 12-week virtual reality-based meditative intervention for 15 patients undergoing methadone maintenance treatment showed promising results, with significant reductions in pain, opioid cravings, anxiety, and depression after each session.

Neuroimaging results indicated that the intervention led to decreased activation in the pain-related brain region (left postcentral gyrus) and altered connectivity patterns, suggesting a potential neurobiological mechanism for the observed behavioral improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Reality Meditative Intervention Modulates Pain and the Pain Neuromatrix in Patients with Opioid Use Disorder. Faraj, MM., Lipanski, NM., Morales, A., et al.[2022]

This study aims to evaluate the safety and effectiveness of virtual reality (VR) therapy for managing acute pain in patients with traumatic injuries, including traumatic brain injury (TBI), using a randomized clinical trial design.

The primary outcome will measure changes in pain intensity during VR sessions compared to control groups, with additional assessments of psychological factors like pain catastrophizing and physiological responses, highlighting the potential of VR as a non-pharmacological intervention to help combat the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive virtual reality pain relief following traumatic injury: protocol for a randomised within-subjects clinical trial. Felix, RB., Rao, A., Khalid, M., et al.[2021]

A pilot clinical trial involving 19 participants with cannabis use disorder and severe mental disorder showed that an innovative avatar intervention led to a significant moderate reduction in cannabis use, with a Cohen's d of 0.611, indicating effectiveness.

The intervention utilized immersive virtual reality techniques, allowing participants to practice therapeutic methods in real-time, suggesting that this novel approach could enhance treatment outcomes for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. Giguère, S., Potvin, S., Beaudoin, M., et al.[2023]

Virtual reality therapy (VRT) was found to be highly acceptable and feasible for integration with standard addiction treatment (TAU) among both therapists and patients in a study involving 21 therapists and 113 patients over 6-12 months.

While VRT showed potential effectiveness in enhancing communication and problem-solving skills for relapse prevention, barriers such as motion sickness, technical issues, and costs were identified, indicating areas for improvement before wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality to Support Inpatient Addiction Treatment: Patients Are Ready, What About Therapists? A Feasibility Study. Arissen, C., van der Helm, L., Dijkstra, B., et al.[2022]

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