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OpenTrials
Completed

NCT Number: NCT06255119

The Feasibility of VR for OUD

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Gavin Foundation

Quincy, Massachusetts, 02170, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.18 years or older

  • Current diagnosis of opioid use disorder
  • Current inpatient in detox ATS unit
  • Fluent in English

Exclusion criteria

  • Active suicidality
  • History of seizures
  • History of psychosis
  • Severe visual impairment

Treatment and study plan

3D Therapy Thrive

Device

A novel virtual reality software intervention that utilizes elements of Cognitive Behavioral Therapy to improve outcomes for inpatients with OUD.

Primary outcomes

  1. Retention in Treatment

    Time frame: At departure from facility, through study completion, an average of 10 days

    Medical record indicating whether patient completed detox protocol (i.e., completed, left against medical advice, administratively discharged, or moved to higher level of care)

  2. Feasibility and Tolerability of 3DTT

    Time frame: Immediately after each treatment

    Feasibility and tolerability of 3DTT was measured by the Side Effects Questionnaire.

Secondary outcomes

  1. Mood

    Time frame: Before and after each treatment, approximately every other day for up to 5 days

    Depressive symptoms as measured by the AB-POMS depression scale (0-4, not at all to extremely)

  2. Anxiety

    Time frame: Before and after each treatment, approximately every other day for up to 5 days

    Anxiety symptoms as measured by the AB-POMS scale (0-4, not at all to extremely)

  3. Cravings

    Time frame: Before and after each treatment, approximately every other day for up to 5 days

    Opioid cravings as measured by the Visual Analog Scale (1-10, with higher scores indicating greater cravings.)

Sponsors and collaborators

Lead sponsor

3D Therapy, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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