Status:
COMPLETED
MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Opioid-use Disorder
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this pilot study is to test the Mindful Recovery OBOT Care Continuum (M-ROCC) model in primary care office-based opioid treatment (OBOT). M-ROCC features integration of evidence-based mind...
Detailed Description
The primary objective of this study is to conduct a single-arm pilot study in order to refine a Mindfulness-Based Intervention for the Opioid Use Disorder (OUD) treatment in primary care, called the M...
Eligibility Criteria
Inclusion
- 18 years or older
- Current CHA patient with a CHA primary care provider
- Diagnosis of opioid use disorder prescribed buprenorphine/naloxone
- Sufficient English fluency to understand procedures and questionnaires
- \<90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, AND alcohol (excluding cannabis/nicotine)
- Ability to provide informed consent.
Exclusion
- Psychosis
- Mania
- Thought disorder
- Schizophrenia or Schizoaffective disorder
- Acute suicidality with plan
- Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) \<24 OR the inability to complete consent quiz and baseline assessments.
- Current participation in another CHA research study
- Expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03798431
Start Date
December 11 2018
End Date
February 3 2020
Last Update
March 14 2025
Active Locations (1)
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1
Cambridge Health Alliance
Somerville, Massachusetts, United States, 02143