Chronic Pain, Opioid Use Disorders
Conditions
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.
Interventions
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.
BEHAVIORALSupport Group
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid misuse | 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 | Change from baseline through study completion (9 months post-treatment) | Brief Pain Inventory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid craving | Change from baseline through study completion (9 months post-treatment) | Opioid craving measure from Wasan et al. 2012 |
| Change in psychological distress | Change from baseline through study completion (9 months post-treatment) | Depression Anxiety Stress Scale |
| Change in opioid dose | Change from baseline through study completion (9 months post-treatment) | Opioid dose converted into morphine equivalents via standardized equianalgesic tables |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in cue-reactivity | 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 nonreactivity | Change from baseline through post-treatment (8 weeks from beginning of treatment) | subscale on Five Facet Mindfulness Questionnaire |
| Change in anhedonia | 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. |
| Change in attention to positive information | Change from baseline through post-treatment (8 weeks from beginning of treatment) | Attention to positive information as evidenced by the APNIS |
| Change in interoceptive awareness | 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 | 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 | 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 | Change from baseline through post-treatment (8 weeks from beginning of treatment) | Positive emotion as evidenced by the PANAS |
Countries
United States
Outcome results
None listed