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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
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.
Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving
University of California, San Diego
La Jolla, California, United States
University of Utah
Salt Lake City, Utah, United States
Days of opioid use
Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen
Time frame: Baseline to post-treatment assessment (8 weeks)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 3 month post-treatment follow-up
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