search
Back to results

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

Primary Purpose

Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MORE-VR
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center on Mindfulness and Integrative Health Intervention Development

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MORE-VR

Arm Description

Mindfulness-Oriented Recovery Enhancement deployed over virtual reality.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events and/or Serious Adverse Events
Number of participants who reported adverse events and serious adverse events.

Secondary Outcome Measures

Engagement
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.
Numeric Rating Scale of State Craving
Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.
Numeric Rating Scale of State Positive Affect
Positive affect measured on a 0 to 10 numeric rating scale, with 0 indicating no positive affect and 10 indicating very high positive affect.

Full Information

First Posted
September 1, 2021
Last Updated
July 18, 2023
Sponsor
University of Utah
Collaborators
BehaVR LLC, National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05034276
Brief Title
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Official Title
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
July 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
BehaVR LLC, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MORE-VR
Arm Type
Experimental
Arm Description
Mindfulness-Oriented Recovery Enhancement deployed over virtual reality.
Intervention Type
Other
Intervention Name(s)
MORE-VR
Intervention Description
Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events and/or Serious Adverse Events
Description
Number of participants who reported adverse events and serious adverse events.
Time Frame
Baseline through week 8
Secondary Outcome Measure Information:
Title
Engagement
Description
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.
Time Frame
Baseline through week 8
Title
Numeric Rating Scale of State Craving
Description
Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.
Time Frame
Baseline through week 8
Title
Numeric Rating Scale of State Positive Affect
Description
Positive affect measured on a 0 to 10 numeric rating scale, with 0 indicating no positive affect and 10 indicating very high positive affect.
Time Frame
Baseline through week 8
Other Pre-specified Outcome Measures:
Title
Desire for Drugs
Description
Desires for Drugs Questionnaire
Time Frame
Baseline, week 8
Title
Trait Positive and Negative Affect
Description
Positive and Negative Affect Schedule
Time Frame
Baseline, week 8
Title
Coping Self-efficacy
Description
Drug Taking Confidence Questionnaire
Time Frame
Baseline, week 8
Title
Cue-elicited Heart Rate
Description
Heart rate during cue exposure minus baseline heart rate
Time Frame
Baseline through week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Center on Mindfulness and Integrative Health Intervention Development
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs