Virtual Reality Mindfulness Treatment for Opioid Use Disorder

Overseen By Eric Garland, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BehaVR LLC

Must be taking: Opioid use disorder medications

Disqualifiers: Mindfulness intervention, Psychosis, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

128 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication. The main question it aims to answer is will people with opioid use disorder who receive the study intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have fewer days in which they use opioids than will people who just receive their usual treatment. Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in addition to their usual treatment, or treatment as usual only. Researchers will compare these groups at the end of treatment and three months after treatment is over on number of days of opioid use and time until first opioid use lapse, as well as drug craving and mood.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, it includes people who are already taking medications for opioid use disorder.

What data supports the effectiveness of the Virtual Reality Mindfulness Treatment for Opioid Use Disorder?

Research shows that mindfulness-based interventions, like the one used in this treatment, can reduce drug cravings and improve emotional regulation in people with opioid use disorder. Additionally, virtual reality has been found to enhance mindfulness practice by creating an immersive environment that helps people focus better and feel more relaxed. ^{1 2 3 4 5}

Is Virtual Reality Mindfulness Treatment safe for humans?

Research on Virtual Reality Mindfulness Treatment, including studies on similar interventions like Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), suggests it is generally safe for humans. Participants in these studies reported improvements in emotional states and mindfulness without significant adverse effects. ^{1 2 3 5 6}

How is the Virtual Reality Mindfulness Treatment for Opioid Use Disorder different from other treatments?

This treatment is unique because it uses virtual reality to enhance mindfulness practice, providing an immersive experience that helps patients focus better and manage pain and cravings more effectively compared to traditional methods. ^{1 2 3 5 7}

Research Team

Risa Weisberg, PhD

Principal Investigator

BehaVR LLC

Eligibility Criteria

This trial is for adults over 18 with opioid use disorder who are currently on medication like buprenorphine or methadone. It's not for those who've done mindfulness training, have active psychosis or suicidality, cognitive impairments, or conditions that make using VR risky (like seizures).

Inclusion Criteria

current DSM-5 OUD diagnosis

I am 18 years old or older.

I am taking medication for opioid addiction.

Exclusion Criteria

I don't have seizures, vertigo, severe motion sickness, or recent concussions.

I have completed a recognized mindfulness program.

I do not have active psychosis or thoughts of suicide.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weekly sessions of Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR) or treatment as usual (TAU)

8 weeks

8 visits (virtual for MORE-VR group)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of opioid use, craving, and mood

12 weeks

3 visits (in-person or virtual)

Treatment Details

Interventions

• Virtual Reality Cognitive-Affective Training

Trial Overview The study tests if a virtual reality program called MORE-VR can help people with opioid addiction better than usual treatments alone. Participants will either get their regular treatment plus weekly MORE-VR sessions for two months or just continue their normal care.

Participant Groups

Group I: MORE-VR Experimental Treatment 2 Interventions

An 8-session version of Mindfulness-Oriented Recovery Enhancement (MORE) delivered by virtual reality. The treatment involves training in mindfulness, reappraisal, and savoring techniques to address OUD. Participants in this arm will also receive Treatment as usual (TAU) with medications for opioid use disorder (MOUD) such as buprenorphine, methadone, or naltrexone plus any psychological counseling they are already receiving in their standard care.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Treatment as usual (TAU) with medications for opioid use disorder (MOUD) such as buprenorphine, methadone, or naltrexone plus any psychological counseling they are already receiving in their standard care.

Who Is Running the Clinical Trial?

BehaVR LLC

Lead Sponsor

Trials

5

Recruited

280+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

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]

A pilot study with 44 mindfulness experts using Virtual Reality (VR) for Dialectical Behavioral Therapy (DBT®) mindfulness training showed significant improvements in state of mindfulness and reductions in negative emotions like sadness, anger, and anxiety.

Participants experienced a strong sense of presence in the VR environment and accepted it as a useful tool for mindfulness practice, suggesting that VR could enhance the accessibility and effectiveness of mindfulness training for those who struggle with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. Navarro-Haro, MV., López-Del-Hoyo, Y., Campos, D., et al.[2023]

A six-week mindfulness-based stress reduction (MBSR) intervention significantly decreased perceived stress, emotional regulation difficulties, and drug cravings in 15 underserved individuals undergoing treatment for opioid use disorder (OUD).

The results suggest that mindfulness interventions can be effective in improving mental health outcomes for vulnerable populations, highlighting the need for larger studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Brief Mindfulness Intervention in Underserved Individuals Receiving Inpatient Treatment for Opioid Use Disorder: A Pilot Study. Kennelly, NR., Ray, S.[2023]

In a study of 19 inpatients with opioid dependence, those who received mindfulness-based interventions (MBI) showed significant improvements in distress tolerance and changes in brain structure compared to those receiving standard treatment.

Specifically, MBI was associated with increased strength in brain networks related to impulse control, suggesting that MBI may enhance treatment outcomes for substance use disorders by affecting neural pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions modulate structural network strength in patients with opioid dependence. Fahmy, R., Wasfi, M., Mamdouh, R., et al.[2019]

In a study of 30 participants undergoing methadone maintenance therapy for opioid use disorder and chronic pain, those who received Mindfulness-Oriented Recovery Enhancement (MORE) showed significantly greater improvements in opioid craving, pain, and positive affect compared to those receiving standard treatment.

Participants in the MORE group reported nearly 1.3 times greater self-control over their cravings, and a stronger link was found between positive affect and reduced craving, suggesting that MORE could be an effective non-drug addition to traditional opioid treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial. Garland, EL., Hanley, AW., Kline, A., et al.[2020]

The pilot study involving 18 adults with Opioid Use Disorder showed that the Mindful Recovery OUD Care Continuum (M-ROCC) was feasible and acceptable, with 89% of participants retained in the program at 4 weeks and 72% at 24 weeks.

Participants demonstrated significant increases in mindfulness over the 24-week period, which correlated with their frequency of mindfulness practice, suggesting that integrating mindfulness-based interventions could enhance retention in buprenorphine/naloxone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. Fatkin, T., Moore, SK., Okst, K., 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. [2023]

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

Efficacy of a Brief Mindfulness Intervention in Underserved Individuals Receiving Inpatient Treatment for Opioid Use Disorder: A Pilot Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions modulate structural network strength in patients with opioid dependence. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial. [2020]

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

Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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