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

NCT06021431 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 001578605R44DA053848
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Opioid Use Disorder

Keywords

Mindfulness; Virtual Reality; Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Days of opioid use at follow-up

  Baseline to 3 months post treatment (20 weeks from baseline)

• Time until opioid lapse

  Baseline through 3 month post-treatment follow-up

• Time until dropout from opioid use disorder treatment

  Baseline through 3 month post-treatment follow-up

• Desire for drugs

  Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period

• Opioid craving

  Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period

Other Outcomes (3)

• Drug cue reactivity

  Baseline to immediately after the intervention

• Emotion regulation

  Baseline to immediately after the intervention

• Theta oscillations

  Baseline to immediately after the intervention

Study Arms (2)

MORE-VR

EXPERIMENTAL

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; Other: Treatment as Usual

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Interventions

MORE-VR DEVICE

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.

Also known as: Mindfulness-Oriented Recovery Enhancement in Virtual Reality

MORE-VR

Treatment as Usual OTHER

Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving

MORE-VR; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• BehaVR LLC: lead
• University of Utah: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• University of California, San Diego: collaborator

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Risa Weisberg, PhD

  BehaVR LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 1, 2023
• Study Start: September 7, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after publication of the primary, secondary, and mechanistic outcomes of the trial.
• Access Criteria: Data will be available with a signed data access agreement

Locations

US (2)