Clinical trial NCT06021431: Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
Official title: Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder: A Phase 2 Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Mindfulness
Virtual Reality
Opioid Use Disorder
Lead sponsor: BehaVR LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Utah
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-09-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Days of opioid use
timeFrame: Baseline to post-treatment assessment (8 weeks)
Secondary outcomes:
measure: Days of opioid use at follow-up
timeFrame: Baseline to 3 months post treatment (20 weeks from baseline)
measure: Time until opioid lapse
timeFrame: Baseline through 3 month post-treatment follow-up
measure: Time until dropout from opioid use disorder treatment
timeFrame: Baseline through 3 month post-treatment follow-up
measure: Desire for drugs
timeFrame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
measure: Opioid craving
timeFrame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
measure: Positive Affect
timeFrame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
measure: Negative Affect
timeFrame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
measure: Positive and Negative Affect Schedule
timeFrame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
measure: Distress
timeFrame: Baseline through 3 month post-treatment follow-up
measure: Health-related Quality of Life
timeFrame: Baseline through 3 month post-treatment follow-up
Other outcomes:
measure: Drug cue reactivity
timeFrame: Baseline to immediately after the intervention
measure: Emotion regulation
timeFrame: Baseline to immediately after the intervention
measure: Theta oscillations
timeFrame: Baseline to immediately after the intervention
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: BehaVR LLC
name: Risa Weisberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: