Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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 or methadone 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:
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 or methadone 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
|
Outcome Measures
Primary Outcome Measures
- Days of opioid use [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 Outcome Measures
- Days of opioid use at follow-up [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
- Time until opioid lapse [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
- Time until dropout from opioid use disorder treatment [Baseline through 3 month post-treatment follow-up]
Number of days unti dropout from treatment, assessed by Timeline Followback and chart review
- Desire for drugs [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
- Opioid craving [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).
- Positive Affect [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).
- Negative Affect [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).
- Positive and Negative Affect Schedule [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)
- Distress [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.
- Health-related Quality of Life [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 Outcome Measures
- Drug cue reactivity [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.
- Emotion regulation [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.
- Theta oscillations [Baseline to immediately after the intervention]
For a subset of participants, we will assess theta oscillations as measured by EEG during meditation
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Utah | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- BehaVR LLC
- University of Utah
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Risa Weisberg, PhD, BehaVR LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00157860
- 5R44DA053848