Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
Completed · Not applicable
Conditions studied: Opioid-use Disorder, Stress Related Disorder, Anxiety, Pain Interference
In brief
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).
Key facts
- Study ID
- NCT04278586
- Run by
- Cambridge Health Alliance
- People needed
- 260
- Starts
- 2021-02-15
- Expected to finish
- 2023-09-19
- Last updated by the study team
- 2025-07-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Substance use severity requiring likely inpatient treatment in opinion of principal investigator (e.g., severe alcohol withdrawal symptoms, severe benzodiazepine withdrawal symptoms, etc.).
- Inability to participate in group intervention without disrupting group in opinion of principal investigator or site PI.
Where it is running
- Cambridge Health Alliance — Somerville, Massachusetts, United States
Full record on ClinicalTrials.gov
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