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

BehaVR

Status: Active, not recruiting

Conditions: Opioid Use Disorder

Treatments: Other: Treatment as Usual; Device: MORE-VR

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06021431

5R44DA053848 (U.S. NIH Grant/Contract)

00157860

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

MORE-VR

Experimental group

Description:

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.

Treatment:

Device: MORE-VR

Other: Treatment as Usual

Treatment as Usual (TAU)

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as Usual