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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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, methadone, or naltrexone plus any psychological counseling they are already receiving in their standard care.

Group Type EXPERIMENTAL

MORE-VR

Intervention Type 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.

Treatment as Usual

Intervention Type OTHER

Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving

Treatment as Usual (TAU)

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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type OTHER

Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type OTHER

Other Intervention Names

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Mindfulness-Oriented Recovery Enhancement in Virtual Reality

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No