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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2020

Interventions

  • Behavioral: Mindfulness-Oriented Recovery Enhancement
    • 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.
  • Behavioral: Support Group
    • A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Arms, Groups and Cohorts

  • Experimental: M.O.R.E.
    • Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
  • Active Comparator: Support Group
    • Participants will attend a support group weekly for eight weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in opioid misuse
    • Time Frame: Change from baseline through study completion (9 months post-treatment)
    • 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 in pain severity and interference
    • Time Frame: Change from baseline through study completion (9 months post-treatment)
    • Brief Pain Inventory

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Utah
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eric Garland, Ph.D. – University of Utah
  • Overall Official(s)
    • Eric Garland, PhD, Principal Investigator, University of Utah

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