The Feasibility of VR for OUD

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06255119
• Other study ID #: 2022/03/9
• Status: Completed
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: 3D Therapy, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

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.

Locations

Country	Name	City	State
United States	The Gavin Foundation	Quincy	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
3D Therapy, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility and Tolerability of 3DTT	Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.	Immediately after each treatment
Secondary	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
Secondary	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
Secondary	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