Opioid-use Disorder
Conditions
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).
Interventions
OTHERMORE-VR
Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
Sponsors
BehaVR LLC
National Institute on Drug Abuse (NIDA)
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| MORE-VR Mindfulness-Oriented Recovery Enhancement deployed over virtual reality.
MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | MORE-VR |
|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 2 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Number of Participants With Adverse Events and/or Serious Adverse Events
Number of participants who reported adverse events and serious adverse events.
Time frame: Baseline through week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORE-VR | Number of Participants With Adverse Events and/or Serious Adverse Events | 2 Participants |
Secondary
Engagement
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.
Time frame: Baseline through week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORE-VR | Engagement | 20 Participants |
Secondary
Numeric Rating Scale of State Craving
Craving measured on a 0 to 10 numeric rating scale, with 0 indicating no craving and 10 indicating extreme craving.
Time frame: Baseline through week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MORE-VR | Numeric Rating Scale of State Craving | 1.22 score on a scale | Standard Error 0.23 |
Secondary
Numeric Rating Scale of State Positive Affect
Positive affect measured on a 0 to 10 numeric rating scale, with 0 indicating no positive affect and 10 indicating very high positive affect.
Time frame: Baseline through week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MORE-VR | Numeric Rating Scale of State Positive Affect | 1.23 score on a scale | Standard Error 0.17 |
Other Pre-specified
Coping Self-efficacy
Drug Taking Confidence Questionnaire
Time frame: Baseline, week 8
Other Pre-specified
Cue-elicited Heart Rate
Heart rate during cue exposure minus baseline heart rate
Time frame: Baseline through week 8
Other Pre-specified
Desire for Drugs
Desires for Drugs Questionnaire
Time frame: Baseline, week 8
Other Pre-specified
Trait Positive and Negative Affect
Positive and Negative Affect Schedule
Time frame: Baseline, week 8