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

Not Applicable

Completed

• Conditions: Opioid Use Disorders; Chronic Pain
• Interventions: Behavioral: Mindfulness-Oriented Recovery Enhancement; Behavioral: Support Group

• Registration Number: NCT02602535
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-11
• Study Start: 2016-01
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M.O.R.E.	Mindfulness-Oriented Recovery Enhancement	Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Support Group	Support Group	Participants will attend a support group weekly for eight weeks.

Primary Outcome Measures

Name	Time	Method
Change in opioid misuse	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	Change from baseline through study completion (9 months post-treatment)	Brief Pain Inventory

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Utah Primary Care Clinics; 🇺🇸 Salt Lake City, Utah, United States