Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Utah
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Changes in fMRI activity level during natural reward processing
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
- •inability or unwillingness of individual to give written informed consent
- •physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
Arms & Interventions
Mindfulness-Oriented Recovery Enhancement
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Intervention: Mindfulness-Oriented Recovery Enhancement (MORE) (Behavioral)
Support Group
Participants will attend a support group weekly for eight weeks.
Intervention: Support Group (Behavioral)
Outcomes
Primary Outcomes
Changes in fMRI activity level during natural reward processing
Time Frame: Change from week 0 to 8 weeks
Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan.
Changes in endogenous opioid system function in response to pain challenge
Time Frame: Change from week 0 to 8 weeks
PET opioid receptor binding potential from baseline through pain challenge
Secondary Outcomes
- Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use(Change from week 0 to 8 weeks)
- Pain sensitivity as a measure of volume of hypertonic saline(Change from week 0 to 8 weeks)
- Self-report affect ratings(Change from week 0 to 8 weeks)
Investigators
Eric Garland
Associate Director of Integrative Medicine in Supportive Oncology and Survivorship, Huntsman Cancer Institute; Associate Dean for Research and Associate Professor, College of Social Work
University of Utah