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Completed

NCT Number: NCT02602535

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Primary Care Clinics

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in opioid misuse

    Time frame: 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

  2. Change in pain severity and interference

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

    Brief Pain Inventory

Secondary outcomes

  1. Change in opioid craving

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

    Opioid craving measure from Wasan et al. 2012

  2. Change in psychological distress

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

    Depression Anxiety Stress Scale

  3. Change in opioid dose

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

    Opioid dose converted into morphine equivalents via standardized equianalgesic tables

Other outcomes

  1. Change in nonreactivity

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

    subscale on Five Facet Mindfulness Questionnaire

  2. Change in interoceptive awareness

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

    Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness

  3. Change in reinterpretation of pain sensations

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

    Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire

  4. Change in emotion regulation

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

    Emotion regulation as evidenced by responses on the Emotion Regulation Task

  5. Change in positive emotion

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

    Positive emotion as evidenced by the PANAS

  6. Change in cue-reactivity

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

    Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure

  7. Change in attention to positive information

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

    Attention to positive information as evidenced by the APNIS

  8. Change in anhedonia

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

    Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 11, 2015
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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