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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Use Disorders
• Intervention / Treatment: Behavioral: Mindfulness-Oriented Recovery Enhancement; Behavioral: Support Group

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Primary Care Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M.O.R.E.; Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.	Behavioral: 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.
Active Comparator: Support Group; Participants will attend a support group weekly for eight weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nonreactivity	subscale on Five Facet Mindfulness Questionnaire	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Change in interoceptive awareness	Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Change in reinterpretation of pain sensations	Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Change in emotion regulation	Emotion regulation as evidenced by responses on the Emotion Regulation Task	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Change in positive emotion	Positive emotion as evidenced by the PANAS	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Change in cue-reactivity	Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Change in attention to positive information	Attention to positive information as evidenced by the APNIS	Change from baseline through post-treatment (8 weeks from beginning of treatment)
Change in anhedonia	Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia.	Change from baseline through study completion (9 months post-treatment)

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Eric Garland, PhD, University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimated): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Chronic Pain
• Other Study ID Numbers: 00078615