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Clinical Trials/NCT02602535
NCT02602535
Completed
Not Applicable

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

University of Utah1 site in 1 country250 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Utah
Enrollment
250
Locations
1
Primary Endpoint
Change in opioid misuse
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
October 2020
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in psychological distress(Change from baseline through study completion (9 months post-treatment))
  • Change in opioid dose(Change from baseline through study completion (9 months post-treatment))
  • Change in opioid craving(Change from baseline through study completion (9 months post-treatment))

Study Sites (1)

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