Clinical trial NCT02602535: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Use Disorders
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in opioid misuse
timeFrame: Change from baseline through study completion (9 months post-treatment)
measure: Change in pain severity and interference
timeFrame: Change from baseline through study completion (9 months post-treatment)
Secondary outcomes:
measure: Change in opioid craving
timeFrame: Change from baseline through study completion (9 months post-treatment)
measure: Change in psychological distress
timeFrame: Change from baseline through study completion (9 months post-treatment)
measure: Change in opioid dose
timeFrame: Change from baseline through study completion (9 months post-treatment)
Other outcomes:
measure: Change in nonreactivity
timeFrame: Change from baseline through post-treatment (8 weeks from beginning of treatment)
measure: Change in interoceptive awareness
timeFrame: Change from baseline through post-treatment (8 weeks from beginning of treatment)
measure: Change in reinterpretation of pain sensations
timeFrame: Change from baseline through post-treatment (8 weeks from beginning of treatment)
measure: Change in emotion regulation
timeFrame: Change from baseline through post-treatment (8 weeks from beginning of treatment)
measure: Change in positive emotion
timeFrame: Change from baseline through post-treatment (8 weeks from beginning of treatment)
measure: Change in cue-reactivity
timeFrame: Change from baseline through post-treatment (8 weeks from beginning of treatment)
measure: Change in attention to positive information
timeFrame: Change from baseline through post-treatment (8 weeks from beginning of treatment)
measure: Change in anhedonia
timeFrame: Change from baseline through study completion (9 months post-treatment)
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Primary Care Clinics
state: Utah
Study officials:
affiliation: University of Utah
name: Eric Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.