Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Opioid Use Disorder, Mindfulness, Virtual Reality, Opioid-Related Disorders, Substance-Related Disorders, MORE-VR

Eligibility

You can join if…

Open to people ages 18 years and up

  • 18 years of age or older
  • current DSM-5 OUD diagnosis
  • prescribed medications for opioid use disorder (e.g., buprenorphine, methadone)

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego
    La Jolla California 92093 United States
  • University of Utah
    Salt Lake City Utah 84112 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BehaVR LLC
ID
NCT06021431
Study Type
Interventional
Participants
Expecting 128 study participants
Last Updated