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.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: MORE-VR; Other: Treatment as Usual

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MORE-VR; 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.	Device: MORE-VR; 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.; Other Names: Mindfulness-Oriented Recovery Enhancement in Virtual Reality; Other: Treatment as Usual; Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving
Active Comparator: Treatment as Usual (TAU); 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.	Other: Treatment as Usual; Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug cue reactivity	For a subset of participants, we will asses change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.	Baseline to immediately after the intervention
Emotion regulation	For a subset of participants, we will assess change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.	Baseline to immediately after the intervention
Theta oscillations	For a subset of participants, we will assess theta oscillations as measured by EEG during meditation	Baseline to immediately after the intervention

Collaborators and Investigators

• Sponsor: BehaVR LLC
• Collaborators: National Institute on Drug Abuse (NIDA); University of California, San Diego; University of Utah
• Investigators: Principal Investigator: Risa Weisberg, PhD, BehaVR LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Opioid Use Disorder; Virtual Reality
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders
• Other Study ID Numbers: 00157860; 5R44DA053848 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be available after publication of the primary, secondary, and mechanistic outcomes of the trial.
• IPD Sharing Access Criteria: Data will be available with a signed data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No