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Opioid-use DisorderMindful-OBOTNCT04278586

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

A study testing Live-Online M-ROCC in people with Opioid-use Disorder and Stress Related Disorder, run by Cambridge Health Alliance at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Live-Online M-ROCC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteUnited States
Study dates
15 Feb 2021to 19 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cambridge Health Alliance

    Somerville, Massachusetts, 02143

Other trials in United States

About this study

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).

Read the 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.

Being tested
Live-Online M-ROCC, Live-Online Control
Medical subject headings
Opioid-Related Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Live-Online M-ROCCBehavioural

    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 ControlBehavioural

    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.

Study groups in NCT04278586
Study groupRoleWhat they receive
Live-Online Mindful Recovery OUD Care ContinuumExperimentalLive-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.
Receives: Behavioral: Live-Online M-ROCC
Live-Online ControlActive comparatorA 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.
Receives: Behavioral: Live-Online Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Weeks 13-24

Secondary outcomes (4)

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

    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.

    Measured: Weeks 13-24

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

    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.

    Measured: Weeks 13-24

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

    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.

    Measured: 24 Weeks

  4. Pain Interference PROMIS (PROMIS-PISF)

    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.

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start15 Feb 2021
  3. Primary completion19 Sep 2023
  4. Study completion19 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278586
Sponsor's protocol ID
CHA-IRB-1114/06/19
Other IDs
R33AT010125
Acronym
Mindful-OBOT
Status last verified
Jul 2025
First submitted
7 Feb 2020
Last updated
22 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38135210

  • 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.

    PubMed 34118705

  • 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.

    PubMed 36470641

  • 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.

    PubMed 39836426

Questions about this trial

What is this clinical trial studying?

A study testing Live-Online M-ROCC in people with Opioid-use Disorder and Stress Related Disorder, run by Cambridge Health Alliance at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods (time frame: Weeks 13-24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04278586, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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