Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care

Study Overview
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Brief Summary
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The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic pain to prescription opioid misuse and addiction. The investigators plan to conduct a full scale clinical trial to determine whether MORE (relative to a support group control condition) can reduce symptoms of chronic pain and opioid misuse among patients who are receiving pain management in primary care via long-term opioid analgesic therapy.

Official Title
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Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care

Conditions
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Chronic Pain, Opioid Use Disorders

Intervention / Treatment
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* Behavioral: Mindfulness-Oriented Recovery Enhancement
* Behavioral: Support Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60+ Current back pain diagnosis as determined from ICD-9 codes in claims data (including but not limited to ICD-9 diagnoses 724.x, or 847.x) or current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4) Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days, and evidence of opioid misuse as indicated by the Current Opioid Misuse Measure Willingness to participate in study interventions and assessments Exclusion Criteria: Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention Active suicidality, schizophrenia, psychotic disorder, and/or substance dependence (other than opioid dependence) Presence of clinically unstable systemic illness judged to interfere with treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M.O.R.E.<br>Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. | Behavioral: Mindfulness-Oriented Recovery Enhancement<br>* Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.<br>|
| Active Comparator: Support Group<br>Participants will attend a support group weekly for eight weeks. | Behavioral: Support Group<br>* A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in opioid misuse | Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen | Change from baseline through study completion (9 months post-treatment) | 
| Change in pain severity and interference | Brief Pain Inventory | Change from baseline through study completion (9 months post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in opioid craving | Opioid craving measure from Wasan et al. 2012 | Change from baseline through study completion (9 months post-treatment) | 
| Change in psychological distress | Depression Anxiety Stress Scale | Change from baseline through study completion (9 months post-treatment) | 
| Change in opioid dose | Opioid dose converted into morphine equivalents via standardized equianalgesic tables | Change from baseline through study completion (9 months post-treatment) |