MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment
Completed · Not applicable
Conditions studied: Opioid-use Disorder, Anxiety, Depression, Stress Related Disorder
In brief
The goal of this pilot study is to test the Mindful Recovery OBOT Care Continuum (M-ROCC) model in primary care office-based opioid treatment (OBOT). M-ROCC features integration of evidence-based mindfulness training with weekly group-based opioid treatment. Primary outcomes include (1) Feasibility measured by implementation of the curriculum into two CHA primary care sites and attendance at weekly sessions; (2) Acceptance via self-report and qualitative interviews. Secondary outcomes include anxiety reduction.
Key facts
- Study ID
- NCT03798431
- Run by
- Cambridge Health Alliance
- People needed
- 25
- Starts
- 2018-12-11
- Expected to finish
- 2020-02-03
- Last updated by the study team
- 2025-03-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older
- Current CHA patient with a CHA primary care provider
- Diagnosis of opioid use disorder prescribed buprenorphine/naloxone
- Sufficient English fluency to understand procedures and questionnaires
- <90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, AND alcohol (excluding cannabis/nicotine)
- Ability to provide informed consent.
You may not qualify if…
- Psychosis
- Mania
- Thought disorder
- Schizophrenia or Schizoaffective disorder
- Acute suicidality with plan
- Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments.
- Current participation in another CHA research study
- Expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.
Where it is running
- Cambridge Health Alliance — Somerville, Massachusetts, United States
Full record on ClinicalTrials.gov
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