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

NCT03798431 | Completed

• 2 other identifiers: CHA-IRB-1094/08/18R21AT010125
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Likelihood of recommending program to a friend

  Percentage of participants who would recommend the program to a friend (score of 4 or 5 on a Likert scale (1-5))

  Week 24

Secondary Outcomes (4)

• Number of weekly sessions attended

  Week 24

• Anxiety PROMIS-SF 8a

  Week 24

• Number of biochemically-confirmed illicit opioid abstinent weeks

  Week 24

• PROMIS-SF 8a (PROMIS-ASF) Pain Interference

  Week 24

Other Outcomes (10)

• Number of biochemically-confirmed cocaine abstinent weeks

  Week 24

• Brief Experiential Avoidance Questionnaire (BEAQ)

  Week 24

• Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)

  Week 24

Study Arms (1)

M-ROCC

EXPERIMENTAL

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.

Behavioral: M-ROCC

Interventions

M-ROCC BEHAVIORAL

1. LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder. 2. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 8 weeks \& 120 minutes/wk. 3. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for grads of LDM for 50 mins/wk. After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness.

M-ROCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Cambridge Health Alliance: lead

Study Sites (1)

Cambridge Health Alliance

Somerville, Massachusetts, 02143, United States

Location

Related Publications (2)

• 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.

  PMID: 34118705 BACKGROUND

• 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.

  PMID: 36470641 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Zev Schuman-Olivier, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be no randomization for this pilot study.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 10, 2019
• Study Start: December 11, 2018
• Primary Completion: February 3, 2020
• Study Completion: February 3, 2020
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)