MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

Cambridge Health Alliance

Status: Completed

Conditions: Stress Related Disorder; Opioid-use Disorder; Depression; Anxiety

Treatments: Behavioral: M-ROCC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03798431

R21AT010125 (U.S. NIH Grant/Contract)

CHA-IRB-1094/08/18

Details and patient eligibility

About

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 mindfulness training with weekly group-based opioid treatment. Primary outcomes include (1) Feasibility measured by implementation of the curriculum into two CHA primary care sites and attendance at weekly sessions; (2) Acceptance via self-report and qualitative interviews. Secondary outcomes include anxiety reduction.

Full 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 Mindful Recovery OUD Care Continuum (M-ROCC). Study investigators will conduct qualitative interviews, assess opioid use, preliminary pre/post measures for participants participating in the pilot study. Additional aims of the pilot study is manual refinement and pilot testing assessment batteries to prepare for a multi-site RCT.

The study will focus on demonstrating feasibility and acceptability of the M-ROCC continuum.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years or older
2. Current CHA patient with a CHA primary care provider
3. Diagnosis of opioid use disorder prescribed buprenorphine/naloxone
4. Sufficient English fluency to understand procedures and questionnaires
5. <90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, AND alcohol (excluding cannabis/nicotine)
6. Ability to provide informed consent.

Exclusion criteria

1. Psychosis
2. Mania
3. Thought disorder
4. Schizophrenia or Schizoaffective disorder
5. Acute suicidality with plan
6. Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments.
7. Current participation in another CHA research study
8. Expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

M-ROCC

Experimental group

Description:

Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed with the clinical needs of OUD patients on buprenorphine and logistic needs of primary care OBOT clinicians in mind. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then ongoing mindful recovery support.

Treatment:

Behavioral: M-ROCC