Opioid-use Disorder Clinical Trial
Official title:
Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder
Verified date | July 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 34 |
Est. completion date | July 22, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Center on Mindfulness and Integrative Health Intervention Development | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | BehaVR, National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Desire for Drugs | Desires for Drugs Questionnaire | Baseline, week 8 | |
Other | Trait Positive and Negative Affect | Positive and Negative Affect Schedule | Baseline, week 8 | |
Other | Coping Self-efficacy | Drug Taking Confidence Questionnaire | Baseline, week 8 | |
Other | Cue-elicited Heart Rate | Heart rate during cue exposure minus baseline heart rate | Baseline through week 8 | |
Primary | 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 | |
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. | 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. | 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. | Baseline through week 8 |
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