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

NCT02602535 | Completed

• 1 other identifier: 00078615
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Use Disorders

Outcome Measures

Primary Outcomes (2)

• Change in opioid misuse

  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 from baseline through study completion (9 months post-treatment)

• Change in pain severity and interference

  Brief Pain Inventory

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

Secondary Outcomes (3)

• Change in opioid craving

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

• 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)

Other Outcomes (8)

• Change in nonreactivity

  Change from baseline through post-treatment (8 weeks from beginning of treatment)

• Change in interoceptive awareness

  Change from baseline through post-treatment (8 weeks from beginning of treatment)

• Change in reinterpretation of pain sensations

  Change from baseline through post-treatment (8 weeks from beginning of treatment)

Study Arms (2)

M.O.R.E.

EXPERIMENTAL

Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.

Behavioral: Mindfulness-Oriented Recovery Enhancement

Support Group

ACTIVE COMPARATOR

Participants will attend a support group weekly for eight weeks.

Behavioral: Support Group

Interventions

Mindfulness-Oriented Recovery Enhancement BEHAVIORAL

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.

M.O.R.E.

Support Group BEHAVIORAL

A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.

Support Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Primary Care Clinics

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• Garland EL, Hudak J, Hanley AW, Bernat E, Froeliger B. Positive Emotion Dysregulation in Opioid Use Disorder and Normalization by Mindfulness-Oriented Recovery Enhancement: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2025 Jul 1;82(7):654-662. doi: 10.1001/jamapsychiatry.2025.0569.

  PMID: 40305010 DERIVED

• Garland EL, Hanley AW, Nakamura Y, Barrett JW, Baker AK, Reese SE, Riquino MR, Froeliger B, Donaldson GW. Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy for Co-occurring Opioid Misuse and Chronic Pain in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):407-417. doi: 10.1001/jamainternmed.2022.0033.

  PMID: 35226053 DERIVED

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Eric Garland, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 11, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 22, 2025

Record last verified: 2020-11

Locations

US (1)