NCT05034276

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

Completed NA Results posted Last updated 20 July 2023

What this trial tests

NA trial testing MORE-VR in Opioid-use Disorder in 34 participants. Completed in 22 July 2022.

Timeline

4 October 2021

Primary endpoint
1 April 2022

22 July 2022

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	4 October 2021
Primary completion	1 April 2022
Estimated completion	22 July 2022
Sites	1 location across United States

Drugs / interventions tested

• MORE-VR

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

University of Utah

Who can join

Adults 18 to 75, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events and/or Serious Adverse Events Primary · Baseline through week 8

Number of participants who reported adverse events and serious adverse events.

Group	Value	95% CI
MORE-VR	2

Engagement Secondary · 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.

Group	Value	95% CI
MORE-VR	20

Numeric Rating Scale of State Craving Secondary · Baseline through week 8

Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.

Group	Value	95% CI
MORE-VR	1.22	± .23

Numeric Rating Scale of State Positive Affect Secondary · 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.

Group	Value	95% CI
MORE-VR	1.23	± .17

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MORE-VR

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (2 terms — click to expand)

Reaction	System	MORE-VR
Nausea	Gastrointestinal disorders	—
Panic attack	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT05034276 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Virtual reality-based Mindfulness-Oriented Recovery Enhancement (MORE-VR) as an adjunct to medications for opioid use disorder: a Phase 1 trial.
   Garland EL, Recasens M, Taple BJ, Donaldson GW, et al · · 2024 · cited 4× · PMID 39172534 · DOI 10.1080/07853890.2024.2392870