CClinicalTrials.gg
CompletedNCT06255119Updated Feb 13, 2024

The Feasibility of VR for OUD

An interventional study of 3D Therapy Thrive in Opioid Use Disorder, sponsored by 3D Therapy, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by 3D Therapy, LLC · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.
  • Registered 8 months after the study started (first participant enrolled Oct 2022, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Opioid Use Disorder

Keywords

  • mood
  • cravings
  • retention
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In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 40 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

This is the only study on the registry with 3D Therapy, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

1.18 years or older

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

Exclusion criteria

Exclusion Criteria

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

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Active VR Group

    Participants received the active virtual therapy intervention.

    Device: 3D Therapy Thrive

  • 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.

Interventions

  • Device3D Therapy Thrive

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

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What researchers measure

Primary outcomes

  1. 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)

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

  2. Feasibility and Tolerability of 3DTT

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

    Time frame: Immediately after each treatment

Secondary outcomes

  1. Mood

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

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

  2. Anxiety

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

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

  3. Cravings

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

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

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Study locations

1 site
  • The Gavin Foundation
    Quincy, Massachusetts 02170, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06255119
Lead sponsor
3D Therapy, LLC
Responsible party
Sponsor
First posted
Feb 13, 2024
Start date
Oct 18, 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Feb 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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