MedTrace Logo

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

NCT03798431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-03-14

No results posted yet for this study

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

Interventions

BEHAVIORAL

M-ROCC

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Cambridge Health Alliance

    lead OTHER

Principal Investigators

  • Zev Schuman-Olivier, MD · Study Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2020-02-03
Completion
2020-02-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798431 on ClinicalTrials.gov