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

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Other: MORE-VR

• Registration Number: NCT05034276
• Lead Sponsor: University of Utah

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-05
• Study Start: 2021-10-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-07-22
• Status Verified: 2023-07
• Results First Submitted: 2023-07-14
• Results First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Results First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MORE-VR	MORE-VR	Mindfulness-Oriented Recovery Enhancement deployed over virtual reality.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events and/or Serious Adverse Events	Baseline through week 8	Number of participants who reported adverse events and serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale of State Craving	Baseline through week 8	Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.
Engagement	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.
Numeric Rating Scale of State Positive Affect	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.

Trial Locations

Locations (1)

Center on Mindfulness and Integrative Health Intervention Development; 🇺🇸 Salt Lake City, Utah, United States