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

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

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.

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