Clinical trial NCT03798431: MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment
Official title: MINDFUL-OBOT Pilot: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment -- Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Anxiety
Depression
Stress Related Disorder
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-01-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There will be no randomization for this pilot study.
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Likelihood of recommending program to a friend
timeFrame: Week 24
Secondary outcomes:
measure: Number of weekly sessions attended
timeFrame: Week 24
measure: Anxiety PROMIS-SF 8a
timeFrame: Week 24
measure: Number of biochemically-confirmed illicit opioid abstinent weeks
timeFrame: Week 24
measure: PROMIS-SF 8a (PROMIS-ASF) Pain Interference
timeFrame: Week 24
Other outcomes:
measure: Number of biochemically-confirmed cocaine abstinent weeks
timeFrame: Week 24
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Week 24
measure: Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
timeFrame: Week 24
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Week 24
measure: Difficulties in Emotion Regulation (DERS) Scale
timeFrame: Week 24
measure: Perceived Stress Scale (PSS) Scale
timeFrame: Week 24
measure: Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Week 24
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Week 24
measure: Sustained Attention to Response Task (SART)
timeFrame: Week 24
measure: Hypothetical Delay Discounting Task (HDT)
timeFrame: Week 24
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Study Principal Investigator
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fatkin T, Moore SK, Okst K, Creedon TB, Samawi F, Fredericksen AK, Roll D, Oxnard A, Le Cook B, Schuman-Olivier Z. Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. J Subst Abuse Treat. 2021 Nov;130:108415. doi: 10.1016/j.jsat.2021.108415. Epub 2021 Apr 15.
citation: Schuman-Olivier Z, Fatkin T, Creedon TB, Samawi F, Moore SK, Okst K, Fredericksen AK, Oxnard AS, Roll D, Smith L, Cook BL, Weiss RD. Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Am J Addict. 2023 May;32(3):244-253. doi: 10.1111/ajad.13364. Epub 2022 Dec 5.