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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021431
• Other study ID #: 00157860
• Secondary ID: 5R44DA053848
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: BehaVR LLC
• Contact: Risa Weisberg, PhD
• Phone: 502-777-1593
• Email: risaweisberg[@]behavr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: May 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
BehaVR LLC	National Institute on Drug Abuse (NIDA), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Theta oscillations	For a subset of participants, we will assess theta oscillations as measured by EEG during meditation	Baseline to immediately after the intervention
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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