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Active, Not Recruiting

NCT Number: NCT06021431

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mindfulness-Oriented Recovery Enhancement in Virtual Reality

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

Primary outcomes

  1. Days of opioid use

    Time frame: Baseline to post-treatment assessment (8 weeks)

    Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen

Secondary outcomes

  1. Days of opioid use at follow-up

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

    Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen

  2. Time until opioid lapse

    Time frame: Baseline through 3 month post-treatment follow-up

    Number of days until opioid lapse assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen

  3. Time until dropout from opioid use disorder treatment

    Time frame: Baseline through 3 month post-treatment follow-up

    Number of days unti dropout from treatment, assessed by Timeline Followback and chart review

  4. Desire for drugs

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

    Desires for Drug Questionnaire, range from 14 to 98, higher scores indicating more intense desires for drugs

  5. Opioid craving

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

    0-10 numeric rating scale via ecological momentary assessment (0=no craving, 10=extreme craving).

  6. Positive Affect

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

    0-10 numeric rating scale via ecological momentary assessment (0=no positive affect, 10=extremely strong positive affect).

  7. Negative Affect

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

    0-10 numeric rating scale via ecological momentary assessment (0=no negative affect, 10=extremely strong negative affect).

  8. Positive and Negative Affect Schedule

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

    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)

  9. Distress

    Time frame: Baseline through 3 month post-treatment follow-up

    Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.

  10. Health-related Quality of Life

    Time frame: Baseline through 3 month post-treatment follow-up

    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.

Other outcomes

  1. Drug cue reactivity

    Time frame: Baseline to immediately after the intervention

    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.

  2. Emotion regulation

    Time frame: Baseline to immediately after the intervention

    For a subset of participants, we will assess change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.

  3. Theta oscillations

    Time frame: Baseline to immediately after the intervention

    For a subset of participants, we will assess theta oscillations as measured by EEG during meditation

Sponsors and collaborators

Lead sponsor

BehaVR LLC

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of California, San Diego
  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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