CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 260 enrolled
Drug / intervention
Live-Online M-ROCC +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04278586
NCT04278586N/ACompleted

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

Cambridge Health Alliance·interventional·Posted Feb 20, 2020·Updated Jul 22, 2025

In Brief

A clinical study evaluating Live-Online M-ROCC and Live-Online Control for Opioid-use Disorder and 3 related conditions. Completed, enrolled 260 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 20, 2020
Enrollment StartFeb 15, 2021
Primary CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.4 years ago

Interventions

Live-Online M-ROCCbehavioral

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 Controlbehavioral

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.