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

July 18, 2023 updated by: Eric Garland, University of Utah
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Center on Mindfulness and Integrative Health Intervention Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events and/or Serious Adverse Events
Time Frame: Baseline through week 8
Number of participants who reported adverse events and serious adverse events.
Baseline through week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement
Time Frame: Baseline through week 8
Net Promoter Score (NPS) is a engagement and satisfaction measurement taken from asking participants how likely they were to recommend the MORE-VR intervention to others on a scale of 0-10. Net Promoter Score (NPS) is calculated by subtracting the percentage of customers who answer the NPS question with a 6 or lower (known as 'detractors') from the percentage of customers who answer with a 9 or 10 (known as 'promoters'). The summary Net Promoter Score is reflected as a percentage.
Baseline through week 8
Numeric Rating Scale of State Craving
Time Frame: Baseline through week 8
Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.
Baseline through week 8
Numeric Rating Scale of State Positive Affect
Time Frame: Baseline through week 8
Positive affect measured on a 0 to 10 numeric rating scale, with 0 indicating no positive affect and 10 indicating very high positive affect.
Baseline through week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desire for Drugs
Time Frame: Baseline, week 8
Desires for Drugs Questionnaire
Baseline, week 8
Trait Positive and Negative Affect
Time Frame: Baseline, week 8
Positive and Negative Affect Schedule
Baseline, week 8
Coping Self-efficacy
Time Frame: Baseline, week 8
Drug Taking Confidence Questionnaire
Baseline, week 8
Cue-elicited Heart Rate
Time Frame: Baseline through week 8
Heart rate during cue exposure minus baseline heart rate
Baseline through week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Institute on Drug Abuse (NIDA)
BehaVR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

July 22, 2022

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00141495
  • R44DA053848 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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