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

NCT ID: NCT02602535

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-10-31

Brief Summary

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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

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Conditions

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Chronic Pain Opioid Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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M.O.R.E.

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

Group Type EXPERIMENTAL

Mindfulness-Oriented Recovery Enhancement

Intervention Type 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.

Support Group

Participants will attend a support group weekly for eight weeks.

Group Type ACTIVE_COMPARATOR

Support Group

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-Oriented Recovery Enhancement

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.

Intervention Type BEHAVIORAL

Support Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Garland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah Primary Care Clinics

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40305010 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35226053 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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00078615

Identifier Type: -

Identifier Source: org_study_id

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