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| ID | Type | Description | Link |
|---|---|---|---|
| R44DA053848 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| BehaVR LLC | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORE-VR | Experimental | Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORE-VR | Other | Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and/or Serious Adverse Events | Number of participants who reported adverse events and serious adverse events. | Baseline through week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Desire for Drugs | Desires for Drugs Questionnaire | Baseline, week 8 |
| Trait Positive and Negative Affect | Positive and Negative Affect Schedule |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center on Mindfulness and Integrative Health Intervention Development | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39172534 | Derived | Garland EL, Recasens M, Taple BJ, Donaldson GW, Weisberg RB. Virtual reality-based Mindfulness-Oriented Recovery Enhancement (MORE-VR) as an adjunct to medications for opioid use disorder: a Phase 1 trial. Ann Med. 2024 Dec;56(1):2392870. doi: 10.1080/07853890.2024.2392870. Epub 2024 Aug 22. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MORE-VR | Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MORE-VR | Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events and/or Serious Adverse Events | Number of participants who reported adverse events and serious adverse events. | Posted | Count of Participants | Participants | Baseline through week 8 |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MORE-VR | Mindfulness-Oriented Recovery Enhancement deployed over virtual reality. MORE-VR: Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
This study was nonrandomized and cannot determine the efficacy of the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Garland | University of Utah | 801-581-3826 | eric.garland@socwk.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2021 | Jul 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Baseline through week 8 |
| 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. | Baseline through week 8 |
| 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. | Baseline through week 8 |
| Baseline, week 8 |
| Coping Self-efficacy | Drug Taking Confidence Questionnaire | Baseline, week 8 |
| Cue-elicited Heart Rate | Heart rate during cue exposure minus baseline heart rate | Baseline through week 8 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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. | Posted | Count of Participants | Participants | Baseline through week 8 |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | Baseline through week 8 |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | Baseline through week 8 |
|
|
|
| Other Pre-specified | Desire for Drugs | Desires for Drugs Questionnaire | Not Posted | Baseline, week 8 | Participants |
| Other Pre-specified | Trait Positive and Negative Affect | Positive and Negative Affect Schedule | Not Posted | Baseline, week 8 | Participants |
| Other Pre-specified | Coping Self-efficacy | Drug Taking Confidence Questionnaire | Not Posted | Baseline, week 8 | Participants |
| Other Pre-specified | Cue-elicited Heart Rate | Heart rate during cue exposure minus baseline heart rate | Not Posted | Baseline through week 8 | Participants |
| 0 |
| 28 |
| 0 |
| 28 |
| 2 |
| 28 |
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
|
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