The Feasibility of VR for OUD

The Feasibility of 3D Therapy Thrive for Inpatients With Opioid Use Disorder

This study aims to evaluate feasibility of a virtual reality software device and measure the effects of the intervention on OUD patient mood, tension and cravings, as well as the effect of treatment on patient retention to their inpatient detox protocol.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: 3D Therapy Thrive

Detailed Description

The primary objective of this study is to evaluate the feasibility and preliminary effectiveness of a novel virtual reality (VR) based intervention; 3D Therapy Thrive (3DTT). Inpatient detoxification can improve outcomes for individuals with opioid use disorder (OUD), however patients often leave treatment early due to mood, tension, and cravings associated with opioid withdrawal. Subjects were recruited from a community inpatient detoxification program and received up to two sessions of 3DTT. The patients completed surveys to assess their mood, distress, cravings, and overall satisfaction with the experience. Retention was measured by protocol completion as reported by clinic staff, independent of the study. A group of patients with OUD consecutively admitted to the program comprised a comparison treatment-as-usual (TAU) group.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Quincy, Massachusetts, United States, 02170
      • The Gavin Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1.18 years or older

2. Current diagnosis of opioid use disorder

3. Current inpatient in detox ATS unit

4. Fluent in English

Exclusion Criteria

1. Active suicidality
2. History of seizures
3. History of psychosis
4. Severe visual impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active VR Group; Participants received the active virtual therapy intervention.	Device: 3D Therapy Thrive; A novel virtual reality software intervention that utilizes elements of Cognitive Behavioral Therapy to improve outcomes for inpatients with OUD.
No Intervention: Control Group; A group of patients concurrently on the ATS unit, otherwise eligible to participate in the study who did not enroll, and did not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in Treatment	Medical record indicating whether patient completed detox protocol (i.e., completed, left against medical advice, administratively discharged, or moved to higher level of care)	At departure from facility, through study completion, an average of 10 days
Feasibility and Tolerability of 3DTT	Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.	Immediately after each treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood	Depressive symptoms as measured by the AB-POMS depression scale (0-4, not at all to extremely)	Before and after each treatment, approximately every other day for up to 5 days
Anxiety	Anxiety symptoms as measured by the AB-POMS scale (0-4, not at all to extremely)	Before and after each treatment, approximately every other day for up to 5 days
Cravings	Opioid cravings as measured by the Visual Analog Scale (1-10, with higher scores indicating greater cravings.)	Before and after each treatment, approximately every other day for up to 5 days

Collaborators and Investigators

• Sponsor: 3D Therapy, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cravings; retention; mood
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2022/03/9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No