Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase) (Mindful-OBOT)

July 8, 2025 updated by: Cambridge Health Alliance
This will be a randomized controlled trial (RCT) designed to compare live-online Mindful Recovery Opioid Care Continuum (M-ROCC) groups with a live-online control group on the primary outcome of number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a RCT comparing Mindful Recovery Opioid Care Continuum (M-ROCC), a 24-week motivationally-responsive, trauma-sensitive, Group-Based Opioid Treatment (GBOT) program to a live-online control group, on the number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).

Clinical secondary outcomes include level of anxiety measured by the Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF), level of pain interference measured by the PROMIS Pain Interference Scale (PROMIS-PISF), and the number of positive oral fluid tests for BZD or cocaine during the final 12 weeks of the study. Other exploratory outcomes will be level of anxiety measured by the Beck anxiety inventory (BAI), 24-week intervention retention, as well as mechanisms of self-regulation assessed by self-report and behavioral measures (emotion regulation, decentering/metacognitive monitoring, interoception, experiential avoidance, self-critical rumination, and self-compassion) and their mediating effects on anxiety and opioid abstinence. Qualitative interviews will be conducted with a minimum of 12 and a maximum of 25 M-ROCC completers until thematic saturation to examine themes regarding live-online mindfulness delivery and to compare responses with our R21 qualitative outcomes from our in-person M-ROCC group model. Computerized Adaptive Testing for Mental Health (CAT-MH) will be used to assess changes in psychiatric co-morbidity. Finally, exploratory outcomes of stigma, mindfulness, perceived stress, pain catastrophizing, interpersonal conflict, and shared identity within group will be measured.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Somerville, Massachusetts, United States, 02143
        • Cambridge Health Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant lives in Massachusetts, Connecticut, Florida, Maine, New Hampshire, New York, Rhode Island, Texas, Vermont, California, Michigan, Illinois, North Carolina, Virginia, Arizona, and Alabama.
  • Diagnosis of opioid use disorder prescribed a stable dose of buprenorphine (at least 4 weeks)
  • Less than 90 days of abstinence (from non-prescribed opioids or benzodiazepines, cocaine, or alcohol) OR OUD with a co-morbid anxiety or stress disorder (as evaluated by Computerized Adaptive Testing for Mental Health [CAT-MH] or PROMIS-ASF > 55).
  • Able to use an electronic device with a videocamera to attend study groups and complete questionnaires.
  • Sufficient English fluency to understand procedures and questionnaires
  • Ability to provide informed consent.

Exclusion Criteria:

  • Active psychosis
  • Bipolar I disorder history or severe level of mania on CAT-MH (>71)
  • Acute suicidality or self-injurious behavior or severe level of suicidality on CAT-SS (>71)
  • Cognitive inability as demonstrated by both the inability to complete an informed consent assessment AND complete the Montreal Cognitive Assessment Blind (MOCA BLIND) <24 on two different days
  • Current participation in another experimental research study
  • Previous participation in an 8-week intensive Mindfulness-Based Intervention in past 3 years or participation in the MINDFUL-OBOT pilot study
  • Expected medical hospitalization in next 6 months
  • Expected incarceration in next 6 months
  • Substance use severity requiring likely inpatient treatment in opinion of principal investigator (e.g., severe alcohol withdrawal symptoms, severe benzodiazepine withdrawal symptoms, etc.).
  • Inability to participate in group intervention without disrupting group in opinion of principal investigator or site PI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Live-Online Mindful Recovery OUD Care Continuum
Live-Online Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed for patients with OUD prescribed buprenorphine to be delivered in a live-online environment. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. The live-online M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then a mindfulness maintenance check-in support group.
Behavioral: Live-Online M-ROCC
  1. LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50-60 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 16 weeks with 60 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 graduates of LDM for 50-60 mins/wk.

After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness.
Active Comparator: Live-Online Control
A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness.
Behavioral: Live-Online Control
A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods
Time Frame: Weeks 13-24
Biochemically-confirmed opioid abstinence, which is defined as the number of two-week periods with a negative oral fluid screen AND no opioid use reported in weekly self report self-report during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
Weeks 13-24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Positive Oral-fluid Toxicology Tests for Cocaine.
Time Frame: Weeks 13-24
Biochemically-confirmed cocaine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
Weeks 13-24
Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines.
Time Frame: Weeks 13-24
Biochemically-confirmed benzodiazepine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
Weeks 13-24
Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF)
Time Frame: 24 Weeks
The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale from 7-35 used to assess patient-reported health status for anxiety. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Higher ratings indicate greater anxiety symptoms while lower ratings indicate less anxiety symptoms. This will be assessed among participants with an anxiety disorder (defined as PROMIS >55 at baseline) as well at weeks 8, 16, and 24.
24 Weeks
Pain Interference PROMIS (PROMIS-PISF)
Time Frame: 24 Weeks
The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five with a total scale range of 7-35. Higher ratings indicate greater pain interference and lower ratings indicate lesser pain interference. This assessment was done at baseline and weeks 8, 16, and 24.
24 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substance Craving Scale (SUBCS)
Time Frame: 24 Weeks
The Substance Craving Scale (SUBCS) is a 6-item scale with a range of 0-60. It includes the 3-item validated Opioid Craving Scale (OCS) as the primary measure with a 0-30 scale based on opioids. The SUBCS adds another 3 items based on other non-opioids substances. The OCS assesses participant craving for Opioids (including fentanyl, heroin, methadone, oxycodone or other opioids) and the (SUBCS) includes the OCS plus other substance use (including illicit drugs [e.g., cocaine, methamphetamine, etc.], using unprescribed pills or prescribed medications in ways or at doses for which they were not prescribed [e.g., Klonopin, etc.], or drinking alcohol). This study uses the 3-items specifically from the Opioid Craving Scale (OCS) as our outcome measure for this study with a range of 0-30 and includes SUBCS as exploratory. Higher ratings on OCS indicate greater opioid craving and lower ratings indicate less opioid craving.
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Zev Schuman-Olivier, MD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

September 19, 2023

Study Completion (Actual)

September 19, 2023

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHA-IRB-1114/06/19
  • R33AT010125 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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