Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 … (NCT04278586) | Clinical Trial Compass
CompletedNot Applicable
Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
United States260 participantsStarted 2021-02-15
Plain-language summary
This will be a randomized controlled trial (RCT) designed to compare live-online Mindful Recovery Opioid Care Continuum (M-ROCC) groups with a live-online control group on the primary outcome of number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test \[negative for opiate, oxycodone, fentanyl, methadone\] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Participant lives in Massachusetts, Connecticut, Florida, Maine, New Hampshire, New York, Rhode Island, Texas, Vermont, California, Michigan, Illinois, North Carolina, Virginia, Arizona, and Alabama.
* Diagnosis of opioid use disorder prescribed a stable dose of buprenorphine (at least 4 weeks)
* Less than 90 days of abstinence (from non-prescribed opioids or benzodiazepines, cocaine, or alcohol) OR OUD with a co-morbid anxiety or stress disorder (as evaluated by Computerized Adaptive Testing for Mental Health \[CAT-MH\] or PROMIS-ASF \> 55).
* Able to use an electronic device with a videocamera to attend study groups and complete questionnaires.
* Sufficient English fluency to understand procedures and questionnaires
* Ability to provide informed consent.
Exclusion Criteria:
* Active psychosis
* Bipolar I disorder history or severe level of mania on CAT-MH (\>71)
* Acute suicidality or self-injurious behavior or severe level of suicidality on CAT-SS (\>71)
* Cognitive inability as demonstrated by both the inability to complete an informed consent assessment AND complete the Montreal Cognitive Assessment Blind (MOCA BLIND) \<24 on two different days
* Current participation in another experimental research study
* Previous participation in an 8-week intensive Mindfulness-Based Intervention in past 3 years or participation in the MINDFUL-OBOT pilot study
* Expected medical hospitalization in next 6 months
* Expected incarceration in next 6 months
* Subs…
What they're measuring
1
Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods