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

Sponsor
University of Utah (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05034276
Collaborator
BehaVR (Other)
30
1
7

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: MORE-VR
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MORE-VR

Mindfulness-Oriented Recovery Enhancement deployed over virtual reality.

Other: MORE-VR
Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.

Outcome Measures

Primary Outcome Measures

  1. Safety, as indicated by adverse events and serious adverse events [Baseline through week 8]

    Types and frequencies of adverse events and serious adverse events

Secondary Outcome Measures

  1. Engagement [Baseline through week 8]

    Net Promoter Score

  2. State craving [Baseline through week 8]

    0 to 10 numeric rating scale

  3. State positive affect [Baseline through week 8]

    0 to 10 numeric rating scale

Other Outcome Measures

  1. Desire for Drugs [Baseline, week 8]

    Desires for Drugs Questionnaire

  2. Trait positive and negative affect [Baseline, week 8]

    Positive and Negative Affect Schedule

  3. Coping self-efficacy [Baseline, week 8]

    Drug Taking Confidence Questionnaire

  4. Cue-elicited heart rate [Baseline through week 8]

    Heart rate during cue exposure minus baseline heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Utah
  • BehaVR

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eric Garland, Distinguished Professor, University of Utah
ClinicalTrials.gov Identifier:
NCT05034276
Other Study ID Numbers:
  • IRB_00141495
First Posted:
Sep 5, 2021
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021