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



Status:Recruiting
Conditions:Anxiety, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:December 11, 2018
End Date:July 8, 2019
Contact:Thomas P Fatkin, BA
Email:tfatkin@challiance.org
Phone:617-806-8567

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

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.

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.

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.
We found this trial at
1
site
Somerville, Massachusetts 02144
Principal Investigator: Zev D Schuman-Olivier, MD
Phone: 617-806-8567
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Somerville, MA
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