Behavioral Interventions for Chronic Pain and Opioid-Related Problems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Change in pain symptoms
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Mindfulness-Oriented Recovery Enhancement
Intervention: Mindfulness-Oriented Recovery Enhancement (Behavioral)
Supportive Counseling
Intervention: Supportive Counseling (Behavioral)
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)
Investigators
Eric Garland
Professor
University of Utah