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

NCT04278586 | Completed Results DMC

• 2 other identifiers: CHA-IRB-1114/06/19R33AT010125
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Opioid-use Disorder; Stress Related Disorder; Anxiety; Pain Interference

Outcome Measures

Primary Outcomes (1)

• Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods

  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 Outcomes (4)

• Number of Positive Oral-fluid Toxicology Tests for Cocaine.

  Weeks 13-24

• Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines.

  Weeks 13-24

• Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF)

  24 Weeks

• Pain Interference PROMIS (PROMIS-PISF)

  24 Weeks

Other Outcomes (1)

• Substance Craving Scale (SUBCS)

  24 Weeks

Study Arms (2)

Live-Online Mindful Recovery OUD Care Continuum

EXPERIMENTAL

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

Live-Online Control

ACTIVE COMPARATOR

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

Interventions

Live-Online M-ROCC BEHAVIORAL

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.

Live-Online Mindful Recovery OUD Care Continuum

Live-Online Control BEHAVIORAL

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.

Live-Online Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cambridge Health Alliance

Somerville, Massachusetts, 02143, United States

Location

Related Publications (4)

• Rosansky JA, Howard L, Goodman H, Okst K, Fatkin T, Fredericksen AK, Sokol R, Gardiner P, Parry G, Cook BL, Weiss RD, Schuman-Olivier ZD. Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT. Contemp Clin Trials. 2024 Feb;137:107417. doi: 10.1016/j.cct.2023.107417. Epub 2023 Dec 20.

  PMID: 38135210 BACKGROUND

• 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 BACKGROUND

• Schuman-Olivier Z, Goodman H, Rosansky J, Fredericksen AK, Barria J, Parry G, Sokol R, Gardiner P, Le Cook B, Weiss RD. Mindfulness Training vs Recovery Support for Opioid Use, Craving, and Anxiety During Buprenorphine Treatment: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2454950. doi: 10.1001/jamanetworkopen.2024.54950.

  PMID: 39836426 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

1. The study had higher attrition levels for M-ROCC than a prior study between during weeks 8-16 after a warning about the increased intensity and trauma-informed choice to remain in group. 2. This study had an evidence-based active comparator and lacked a control condition with no behavioral treatment. 3. The predominantly White sample reflects national trends in buprenorphine treatment engagement and existing disparities in equitable treatment access, but limits study generalizability.

Results Point of Contact

• Title: Dr. Zev Schuman-Olivier
• Organization: Cambridge Health Alliance

zschuman@cha.harvard.edu

617-591-6056

Study Officials

• Zev Schuman-Olivier, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigator will be masked to arm assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms, live-online M-ROCC and live-online control, which are randomly assigned in a 1:1 ratio at the same time and are implemented in parallel.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 20, 2020
• Study Start: February 15, 2021
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)