Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
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 |
---|---|---|
|
N/A |
Study Design
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
- 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
- Engagement [Baseline through week 8]
Net Promoter Score
- State craving [Baseline through week 8]
0 to 10 numeric rating scale
- State positive affect [Baseline through week 8]
0 to 10 numeric rating scale
Other Outcome Measures
- Desire for Drugs [Baseline, week 8]
Desires for Drugs Questionnaire
- Trait positive and negative affect [Baseline, week 8]
Positive and Negative Affect Schedule
- Coping self-efficacy [Baseline, week 8]
Drug Taking Confidence Questionnaire
- Cue-elicited heart rate [Baseline through week 8]
Heart rate during cue exposure minus baseline heart rate
Eligibility Criteria
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
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Cognitive impairment (per self-report or report by clinician)
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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.- IRB_00141495