Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation

Study Overview
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Brief Summary
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The overarching aim of this project is to conduct a randomized controlled study to determine whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.

Official Title
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Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients

Conditions
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Chronic, Non-neuropathic Back Pain

Intervention / Treatment
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* Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
* Behavioral: Support Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 21-60 years of age English fluency 20/20 vision with corrective lenses current chronic, non-neuropathic back pain diagnosis determined by physician assessment reporting pain ≥3 on 0-10 scale with opioid medication current use of prescription opioids for ≥3 consecutive months ability to understand study procedures and to comply with them for the entire length of the study Exclusion Criteria: Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation) psychosis untreated, active suicidality in the past month and severe non-opioid substance use disorder in the past year as assessed with the MINI clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain pregnancy inability or unwillingness of individual to give written informed consent physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Oriented Recovery Enhancement<br>Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks. | Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)<br>* 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.<br>|
| Active Comparator: Support Group<br>Participants will attend a support group weekly for eight weeks. | Behavioral: Support Group<br>* A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in endogenous opioid system function in response to pain challenge | PET opioid receptor binding potential from baseline through pain challenge | Change from week 0 to 8 weeks | 
| Changes in fMRI activity level during natural reward processing | Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan. | Change from week 0 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensitivity as a measure of volume of hypertonic saline | Volume of hypertonic saline to maintain pain at 40 out of 100 on a VAS | Change from week 0 to 8 weeks | 
| Self-report affect ratings |  | Change from week 0 to 8 weeks | 
| Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use |  | Change from week 0 to 8 weeks |