Virtual Reality Mindfulness Treatment for Opioid Use Disorder

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a virtual reality program can help people with opioid use disorder reduce their opioid use. Participants will either engage in virtual reality mindfulness sessions (known as Virtual Reality Cognitive-Affective Training or Mindfulness-Oriented Recovery Enhancement in Virtual Reality) or continue their usual treatment. The study will compare the two groups in terms of reducing opioid use and managing cravings. It suits individuals currently taking medication for opioid use disorder who have not yet received a formal mindfulness program. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could complement existing therapies.

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

Research shows that the Virtual Reality Mindfulness Treatment, or MORE-VR, has been tested as an additional therapy for people with opioid use disorder. In past studies, researchers used MORE-VR alongside common medications like buprenorphine, methadone, or naltrexone. These studies found that MORE-VR can be safely combined with these medications.

Participants in earlier trials of MORE-VR did not report major side effects. The goal of MORE-VR is to teach mindfulness, which helps people handle cravings and emotions. This therapy is delivered through virtual reality, offering a unique and interactive experience.

While the trial phase often provides insights into safety, MORE-VR has already been tested in people, indicating it is generally well-tolerated. However, participants should always consult their healthcare provider about any concerns before starting a new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for opioid use disorder, which typically rely on medications like buprenorphine, methadone, or naltrexone, the Virtual Reality Cognitive-Affective Training offers a unique approach. This treatment uses virtual reality to deliver an 8-session program called Mindfulness-Oriented Recovery Enhancement (MORE), which focuses on mindfulness, reappraisal, and savoring techniques. Researchers are excited about this method because it combines immersive technology with psychological strategies to address not just the physical aspects of addiction but also the mental and emotional challenges, potentially enhancing overall recovery outcomes.

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

Research shows that Mindfulness-Oriented Recovery Enhancement through Virtual Reality (MORE-VR), which participants in this trial may receive, can aid individuals with opioid use disorder. Studies have found that combining MORE-VR with medications like buprenorphine or methadone leads to better outcomes for those managing opioid use. It may reduce opioid cravings and improve mood. MORE-VR includes techniques such as mindfulness, reappraisal (changing thought patterns), and savoring (enjoying positive experiences). These techniques help individuals manage cravings and emotions more effectively. Early results suggest that MORE-VR could be a promising addition to standard treatment methods. ^{1 2 3 4 6}

Who Is on the Research Team?

Risa Weisberg, PhD

Principal Investigator

BehaVR LLC

Are You a Good Fit for This Trial?

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 taking medication for opioid addiction.

Exclusion Criteria

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

I do not have active psychosis or thoughts of suicide.

I have completed a recognized mindfulness program.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11342816/

Virtual reality-based Mindfulness-Oriented Recovery ... Our findings show that MORE-VR can be delivered as an adjunctive intervention to MOUD and suggest that MORE-VR may improve OUD treatment outcomes and modulate ...

2. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06021431

UCSD Opioid Use Trial → Virtual Reality Cognitive-Affective ... This project is a Phase II, two-arm, parallel randomized controlled trial (RCT) of a virtual reality form of Mindfulness-Oriented Recovery Enhancement (MORE-VR) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39172534/

Virtual reality-based Mindfulness-Oriented Recovery ... MORE-VR is a digital therapeutic that uses Virtual Reality to deliver an 8-week mindfulness-based intervention for opioid use disorder treatment.

4. researchgate.net researchgate.net/publication/383309302_Virtual_reality-based_Mindfulness-Oriented_Recovery_Enhancement_MORE-VR_as_an_adjunct_to_medications_for_opioid_use_disorder_a_Phase_1_trial

(PDF) Virtual reality-based Mindfulness-Oriented Recovery ... Virtual reality-based Mindfulness-Oriented Recovery Enhancement (MORE-VR) as an adjunct to medications for opioid use disorder: a Phase 1 trial.

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT05546749/Prot_SAP_000.pdf

virtual reality treatment in a methadone maintenance ... Mindfulness-Oriented Recovery Enhancement reduces opioid craving, pain, and negative affect among chronic pain patients on long-term opioid therapy: An.

6. thisweekinaddictionmedicine.podbean.com thisweekinaddictionmedicine.podbean.com/e/lead-virtual-reality-based-mindfulness-oriented-recovery-enhancement-more-vr-as-an-adjunct-to-medications-for-opioid-use-disorder-a-phase-1-trial/

Lead: Virtual reality-based Mindfulness-Oriented Recovery ... MORE has been shown to reduce drug cue reactivity and in an RCT reduced opioid misuse 45% at 9 months. Face-to-face MORE requires significant ...