Status:
COMPLETED
Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Opioid-use Disorder
Stress Related Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 numbe...
Detailed Description
The investigators will conduct a RCT comparing Mindful Recovery Opioid Care Continuum (M-ROCC), a 24-week motivationally-responsive, trauma-sensitive, Group-Based Opioid Treatment (GBOT) program to a ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2023
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04278586
Start Date
February 15 2021
End Date
September 19 2023
Last Update
July 22 2025
Active Locations (1)
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1
Cambridge Health Alliance
Somerville, Massachusetts, United States, 02143