Opioid Use DisorderNCT06021431
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
A study testing MORE-VR and Treatment as Usual in people with Opioid Use Disorder, run by BehaVR LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- MORE-VR and Treatment as Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Sep 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- current DSM-5 OUD diagnosis
- prescribed medications for opioid use disorder (e.g., buprenorphine, methadone)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego
La Jolla, California, 92093
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- MORE-VR, Treatment as Usual
- Keywords
- Mindfulness, Virtual Reality, Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORE-VRDevice
Also called Mindfulness-Oriented Recovery Enhancement in Virtual Reality
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.
Treatment as UsualOther
Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of opioid use
Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen
Measured: Baseline to post-treatment assessment (8 weeks)
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline through 3 month post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start7 Sep 2023
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BehaVR LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Utah, National Institute on Drug Abuse (NIDA), University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Risa Weisberg, PhD, Principal investigator, BehaVR LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021431
- Sponsor's protocol ID
- 00157860
- Other IDs
- 5R44DA053848
- Status last verified
- Jun 2025
- First submitted
- 28 Aug 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder: A Phase 2 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06021431
- Acronym / sponsor ID
- 00157860
- Conditions
- Opioid Use Disorder
- Keywords
- Mindfulness, Virtual Reality, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- BehaVR LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Utah, National Institute on Drug Abuse (NIDA), University of California, San Diego
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORE-VR | Experimental | Device: MORE-VR, Other: Treatment as UsualAn 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. |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as UsualTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- current DSM-5 OUD diagnosis
- prescribed medications for opioid use disorder (e.g., buprenorphine, methadone)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORE-VRAlso: Mindfulness-Oriented Recovery Enhancement in Virtual RealityAn 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. | Device | MORE-VR |
| Treatment as UsualParticipants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving | Other | MORE-VR, Treatment as Usual (TAU) |
Primary outcome
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
10 secondary outcomes
Days of opioid use at follow-up
Time frame: Baseline to 3 months post treatment (20 weeks from baseline)
Time until opioid lapse
Time frame: Baseline through 3 month post-treatment follow-up
Time until dropout from opioid use disorder treatment
Time frame: Baseline through 3 month post-treatment follow-up
Desire for drugs
Time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
Opioid craving
Time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
Positive Affect
Time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
Negative Affect
Time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
Positive and Negative Affect Schedule
Time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
Distress
Time frame: Baseline through 3 month post-treatment follow-up
Health-related Quality of Life
Time frame: Baseline through 3 month post-treatment follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risa Weisberg, PhD principal investigator
BehaVR LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORE-VR and Treatment as Usual in people with Opioid Use Disorder, run by BehaVR LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of opioid use (time frame: Baseline to post-treatment assessment (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.