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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02935465
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : October 17, 2016
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Eric Garland, University of Utah

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.

Condition or disease Intervention/treatment Phase
Chronic, Non-neuropathic Back Pain Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) Behavioral: Support Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
Study Start Date : September 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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.

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.

Primary Outcome Measures :
  1. 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

  2. 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.

Secondary Outcome Measures :
  1. Pain sensitivity as a measure of volume of hypertonic saline [ Time Frame: Change from week 0 to 8 weeks ]
    Volume of hypertonic saline to maintain pain at 40 out of 100 on a VAS

  2. Self-report affect ratings [ Time Frame: Change from week 0 to 8 weeks ]
  3. Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use [ Time Frame: Change from week 0 to 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02935465

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Contact: Eric L Garland, PhD
Contact: Sarah Priddy, MSSW

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United States, Utah
College of Social Work Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Karen Wheeler    801-581-8028   
Sponsors and Collaborators
University of Utah
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Eric L Garland, PhD The University of Utah

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Responsible Party: 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 Identifier: NCT02935465     History of Changes
Other Study ID Numbers: 00093561
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Back Pain
Neurologic Manifestations
Signs and Symptoms