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 |
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.
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.
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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