Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
2 other identifiers
interventional
34
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2022
CompletedResults Posted
Study results publicly available
July 20, 2023
CompletedJuly 20, 2023
July 1, 2023
6 months
September 1, 2021
July 14, 2023
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events and/or Serious Adverse Events
Number of participants who reported adverse events and serious adverse events.
Baseline through week 8
Secondary Outcomes (3)
Engagement
Baseline through week 8
Numeric Rating Scale of State Craving
Baseline through week 8
Numeric Rating Scale of State Positive Affect
Baseline through week 8
Other Outcomes (4)
Desire for Drugs
Baseline, week 8
Trait Positive and Negative Affect
Baseline, week 8
Coping Self-efficacy
Baseline, week 8
- +1 more other outcomes
Study Arms (1)
MORE-VR
EXPERIMENTALMindfulness-Oriented Recovery Enhancement deployed over virtual reality.
Interventions
Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Eligibility Criteria
You may qualify if:
- Age 18 or older
- DSM-5 opioid use disorder diagnosis
- treated with medications for opioid use disorder (MOUD)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- BehaVR LLCcollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112, United States
Related Publications (1)
Garland EL, Recasens M, Taple BJ, Donaldson GW, Weisberg RB. Virtual reality-based Mindfulness-Oriented Recovery Enhancement (MORE-VR) as an adjunct to medications for opioid use disorder: a Phase 1 trial. Ann Med. 2024 Dec;56(1):2392870. doi: 10.1080/07853890.2024.2392870. Epub 2024 Aug 22.
PMID: 39172534DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was nonrandomized and cannot determine the efficacy of the intervention.
Results Point of Contact
- Title
- Eric Garland
- Organization
- University of Utah
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
September 1, 2021
First Posted
September 5, 2021
Study Start
October 4, 2021
Primary Completion
April 1, 2022
Study Completion
July 22, 2022
Last Updated
July 20, 2023
Results First Posted
July 20, 2023
Record last verified: 2023-07