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

• ClinicalTrials.gov Identifier: NCT02602535
• Recruitment Status: Completed
• First Posted: November 11, 2015
• Last Update Posted: November 5, 2020
• Sponsor: University of Utah
• Information provided by (Responsible Party): Eric Garland, University of Utah

Tracking Information

• First Submitted Date: October 26, 2015
• First Posted Date: November 11, 2015
• Last Update Posted Date: November 5, 2020
• Study Start Date: January 2016
• Actual Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2017)

• 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
• Change in pain severity and interference [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
  Brief Pain Inventory

Original Primary Outcome Measures (submitted: November 9, 2015)

• Change in opioid misuse [ Time Frame: Change from baseline through study completion (6 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 [ Time Frame: Change from baseline through study completion (6 months post-treatment) ]
  Brief Pain Inventory

Current Secondary Outcome Measures (submitted: February 6, 2018)

• Change in opioid craving [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
  Opioid craving measure from Wasan et al. 2012
• Change in psychological distress [ Time Frame: Change from baseline through study completion (9 months post-treatment) ]
  Depression Anxiety Stress Scale
• 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

Original Secondary Outcome Measures (submitted: November 9, 2015)

• Change in opioid craving [ Time Frame: Change from baseline through study completion (6 months post-treatment) ]
  Visual Analog Score
• Change in psychological distress [ Time Frame: Change from baseline through study completion (6 months post-treatment) ]
  Depression Anxiety Stress Scale
• Change in opioid dose [ Time Frame: Change from baseline through study completion (6 months post-treatment) ]
  Opioid dose converted into morphine equivalents via standardized equianalgesic tables

Current Other Pre-specified Outcome Measures (submitted: March 5, 2020)

• Change in nonreactivity [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
  subscale on Five Facet Mindfulness Questionnaire
• 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
• 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
• 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
• 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
• 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
• 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
• 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.

Original Other Pre-specified Outcome Measures (submitted: November 9, 2015)

• Change in nonreactivity [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
  subscale on Five Facet Mindfulness Questionnaire
• Change in reinterpretation of pain sensations [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
  subscale on the Coping Strategies Questionnaire
• Change in reappraisal [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
  subscale on the Cognition Emotion Regulation Questionnaire
• Change in savoring [ Time Frame: Change from baseline through post-treatment (8 weeks from beginning of treatment) ]
  Ways of Savoring Checklist

Descriptive Information

• Brief Title: Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
• Official Title: Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Chronic Pain
• Opioid Use Disorders

Intervention

• 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.
• 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.

Study Arms

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 3, 2020): 250
• Original Estimated Enrollment (submitted: November 9, 2015): 260
• Actual Study Completion Date: October 2020
• Actual Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02602535
• Other Study ID Numbers: 00078615
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eric Garland, University of Utah
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Utah
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eric Garland, PhD; University of Utah

• PRS Account: University of Utah
• Verification Date: November 2020