Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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) versus treatment as usual (TAU) for patients receiving medications for opioid use disorder (MOUD) to assess the efficacy of the MORE-VR system. Participants will be randomized (1:1) to either 8 weekly sessions of MORE-VR or TAU. Participants will be assessed at intake, post-treatment, and a 3 month post-treatment follow-up. The primary outcome assessed will be days of opioid use.

Official Title
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Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder: A Phase 2 Randomized Controlled Trial

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Device: MORE-VR
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older current DSM-5 OUD diagnosis prescribed medications for opioid use disorder (e.g., buprenorphine, methadone) Exclusion Criteria: completion of a standardized mindfulness intervention (e.g., MORE, MBRP, MBSR) active psychosis or suicidality reports, or is noted by clinical or study staff as showing cognitive impairment condition which might be contraindicated for VR use including seizure disorder, vertigo, severe motion sickness, recent concussion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORE-VR<br>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 or methadone plus any psychological counseling they are already receiving in their standard care. | Device: MORE-VR<br>* 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. Combination Product: Participants in this arm will also receive Treatment as usual (TAU) with medications for opioid use disorder (MOUD). Usual addictions treatment with medications such as buprenorphine or methadone plus psychological counseling.<br>* Other names: Mindfulness-Oriented Recovery Enhancement in Virtual Reality;Other: Treatment as Usual<br>* Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving<br>|
| Active Comparator: Treatment as Usual (TAU)<br>Treatment as usual (TAU) with medications for opioid use disorder (MOUD) such as buprenorphine or methadone plus any psychological counseling they are already receiving in their standard care. | Other: Treatment as Usual<br>* Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of opioid use | Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen | Baseline to post-treatment assessment (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of opioid use at follow-up | Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen | Baseline to 3 months post treatment (20 weeks from baseline) | 
| Time until opioid lapse | Number of days until opioid lapse assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen | Baseline through 3 month post-treatment follow-up | 
| Time until dropout from opioid use disorder treatment | Number of days unti dropout from treatment, assessed by Timeline Followback and chart review | Baseline through 3 month post-treatment follow-up | 
| Desire for drugs | Desires for Drug Questionnaire, range from 14 to 98, higher scores indicating more intense desires for drugs | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | 
| Opioid craving | 0-10 numeric rating scale via ecological momentary assessment (0=no craving, 10=extreme craving). | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | 
| Positive Affect | 0-10 numeric rating scale via ecological momentary assessment (0=no positive affect, 10=extremely strong positive affect). | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | 
| Negative Affect | 0-10 numeric rating scale via ecological momentary assessment (0=no negative affect, 10=extremely strong negative affect). | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | 
| Positive and Negative Affect Schedule | A 20-item scale measuring both positive and negative affect, where each affective term is rated on a scale of 1 (not at all) to 5 (very much) | Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period | 
| Distress | Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress. | Baseline through 3 month post-treatment follow-up | 
| Health-related Quality of Life | World Health Organization Quality of Life Scale Quality of life measured by the World Health Organization Quality of Life Scale (WHO-5), scores ranging from 0 to 25, with higher scores indicating better quality of life. | Baseline through 3 month post-treatment follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Virtual Reality, Opioid Use Disorder