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

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

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 Overview

• Status: Terminated
• Conditions: Chronic, Non-neuropathic Back Pain
• Intervention / Treatment: Behavioral: Support Group; Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • College of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age 21-60 years of age
2. English fluency
3. 20/20 vision with corrective lenses
4. current chronic, non-neuropathic back pain diagnosis determined by physician assessment
5. reporting pain ≥3 on 0-10 scale with opioid medication
6. current use of prescription opioids for ≥3 consecutive months
7. ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

1. Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation)
2. psychosis
3. untreated, active suicidality in the past month
4. and severe non-opioid substance use disorder in the past year as assessed with the MINI
5. clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain
6. pregnancy
7. inability or unwillingness of individual to give written informed consent
8. physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Support Group; Participants will attend a support group weekly for eight weeks.	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.
Experimental: Mindfulness-Oriented Recovery Enhancement; Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.	Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Eric L Garland, PhD, The University of Utah

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 00093561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED