Virtual Reality Intervention for Opioid Use Disorder

(PARK Trial)

Recruiting at 1 trial location

Overseen By Colton M Lind, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Psychotropic drugs

Disqualifiers: Unstable medical, psychiatric, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to demonstrate the commercial potential for a novel virtual reality (VR) intervention in preparation for Phase II development. This clinical trial will test the VR intervention for efficacy in reducing opioid use, increasing abstinence, and other self-reported and behavioral focus on future outcomes in individuals in early recovery from opioid use disorder. * Will the VR group, compared to the control group, have a lower number of opioid use days? * Will the VR group, compared to the control group, have longer periods of abstinence at the 30-day follow-up? * Will the VR group, compared to the control group, have significantly increased opioid abstinence rates? * Will the VR group, compared to baseline and the control group, show increased future self-identification post-VR intervention? * Will the VR group, compared to baseline and the control group, show increased future orientation post-VR intervention? * Will the VR group, compared to baseline and the control group, show an increased preference for delayed rewards in a laboratory delay discounting task post-VR intervention? * Will the VR group, compared to baseline and the control group, exceed in behavioral effects (i.e., future self-identification, future orientation, and increased preference for delayed rewards) at the 30-day follow-up? Researchers will compare the VR test group and the control group 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. 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 data supports the effectiveness of this treatment for opioid use disorder?

Research suggests that virtual reality therapy can be beneficial for treating substance use disorders, including cannabis use disorder, by reducing drug use and enhancing therapy through realistic and personalized scenarios. It has shown promise in improving treatment outcomes and is well-received by both patients and therapists. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating opioid use disorder?

Virtual reality therapy has been used safely in various treatments, including for anxiety and pain relief, and is considered suitable for adults and people with mental health issues, provided risks like relapse and trauma are managed. Practitioners view it as a safe and realistic option for substance use disorder treatments. ^{3 4 5 6 7}

How is Virtual Reality Avatar Intervention different from other treatments for opioid use disorder?

Virtual Reality Avatar Intervention is unique because it uses immersive virtual reality experiences to help manage pain and improve coping strategies, offering a non-drug, digital approach that complements traditional medication and counseling for opioid use disorder. ^{6 7 8 9 10}

Research Team

Brandon G Oberlin, PhD

Principal Investigator

Indiana University

Eligibility Criteria

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.

I am between 18 and 60 years old.

Exclusion Criteria

Unstable psychiatric conditions

Presence of extravagant/elaborate face tattoos

I have problems with my sense of smell or taste.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Virtual Reality Experimental Treatment 2 Interventions

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

Group II: Treatment As Usual (Control) Placebo Group 1 Intervention

Participants in this arm will receive the following interventions: 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+

Findings from Research

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]

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]

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 (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]

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]

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]

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]

References

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

Virtual Reality to Support Inpatient Addiction Treatment: Patients Are Ready, What About Therapists? A Feasibility Study. [2022]

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

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality (VR) in Assessment and Treatment of Addictive Disorders: A Systematic Review. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

A Virtual Reality Meditative Intervention Modulates Pain and the Pain Neuromatrix in Patients with Opioid Use Disorder. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adjunctive virtual reality pain relief following traumatic injury: protocol for a randomised within-subjects clinical trial. [2021]

8. Switzerland 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. [2022]

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

Digital interventions for opioid use disorder treatment: A systematic review of randomized controlled trials. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]