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Clinical Trials/NCT03298269
NCT03298269
Completed
Not Applicable

Behavioral Interventions for Chronic Pain and Opioid-Related Problems

University of Utah1 site in 1 country95 target enrollmentSeptember 26, 2017
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Utah
Enrollment
95
Locations
1
Primary Endpoint
Change in pain symptoms
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.

Registry
clinicaltrials.gov
Start Date
September 26, 2017
End Date
October 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Garland

Professor

University of Utah

Eligibility Criteria

Inclusion Criteria

  • Age 18-60+
  • Current chronic pain condition
  • Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \>90 days

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 severe substance dependence (other than opioid dependence)
  • Opioid misuse as determined by Current Opioid Misuse Measure

Outcomes

Primary Outcomes

Change in pain symptoms

Time Frame: Change from baseline through study completion (9 months post-treatment)

Pain severity and interference as measured by the Brief Pain Inventory

Change in aberrant drug-related behaviors

Time Frame: Change from baseline through study completion (9 months post-treatment)

Aberrant drug-related behaviors as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen

Secondary Outcomes

  • Change in opioid craving(Change from baseline through study completion (9 months post-treatment))
  • Change in interoceptive awareness(Change from baseline through 8 weeks)
  • Change in emotional 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 savoring(Change from baseline through 8 weeks)
  • Change in meditative experiences(Change from baseline through 8 weeks)
  • Change in reappraisal(Change from baseline through 8 weeks)
  • Change in body sensations(Change from baseline through 8 weeks)

Study Sites (1)

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