Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2022-07-22

Brief Summary

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This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).

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Detailed Description

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Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MORE-VR

Mindfulness-Oriented Recovery Enhancement deployed over virtual reality.

Group Type EXPERIMENTAL

MORE-VR

Intervention Type OTHER

Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.

Interventions

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MORE-VR

Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* DSM-5 opioid use disorder diagnosis
* treated with medications for opioid use disorder (MOUD)

Exclusion Criteria

* Mindfulness intervention experience (MBSR, MBRP)
* Active psychosis or high risk of suicidality
* Cognitive impairment (per self-report or report by clinician)
* Unwilling or unable to remain in MOUD treatment for duration of study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No