Trial Outcomes & Findings for Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder (NCT NCT05034276)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Baseline through week 8

Results posted on

2023-07-20

Participant Flow

34 participants were enrolled but only 28 participants started the intervention and attended the first treatment session. The other 6 participants were lost-to-follow up prior to initiation of the study intervention. This type of dropout is common among patients with opioid use disorder.

Participant milestones

Participant milestones
Measure	MORE-VR Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Overall Study STARTED	28
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MORE-VR n=28 Participants Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Age, Continuous	38.5 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through week 8

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

Outcome measures

Outcome measures
Measure	MORE-VR n=28 Participants Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Number of Participants With Adverse Events and/or Serious Adverse Events	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MORE-VR n=28 Participants Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Engagement	20 Participants

SECONDARY outcome

Timeframe: Baseline through week 8

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

Outcome measures

Outcome measures
Measure	MORE-VR n=28 Participants Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Numeric Rating Scale of State Craving	1.22 score on a scale Standard Error .23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MORE-VR n=28 Participants Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Numeric Rating Scale of State Positive Affect	1.23 score on a scale Standard Error .17

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, week 8

Other adverse events

Other adverse events
Measure	MORE-VR n=28 participants at risk Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Gastrointestinal disorders Nausea	3.6% 1/28 • Number of events 1 • 3 months
Psychiatric disorders Panic attack	3.6% 1/28 • Number of events 1 • 3 months

Additional Information

Eric Garland

University of Utah

Phone: 801-581-3826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place