N/A
Completed N=196
Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
Opioid Use Disorder · Stress Related Disorder · Anxiety · Pain Interference
Source: ClinicalTrials.gov NCT04278586 ↗
Enrolled (actual)
196
Serious AEs
4.6%
Results posted
Jul 2025
Primary outcomePrimary: Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods — 13.4; 12.7 percentage of 2-week time periods
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Biochemically-confirmed Opioid Abstinent 2-week Time Periods |
13.4; 12.7 | — |
| SECONDARY Number of Positive Oral-fluid Toxicology Tests for Cocaine. |
8.4; 1.5 | — |
| SECONDARY Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines. |
22.1; 20.2 | — |
| SECONDARY Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) |
-9.0; -10.0 | — |
| SECONDARY Pain Interference PROMIS (PROMIS-PISF) |
-4.1; -4.4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04278586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.