Chronic, Non-neuropathic Back Pain Clinical Trial
Official title:
Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
| NCT number | NCT02935465 |
| Other study ID # | 00093561 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2016 |
| Est. completion date | June 2019 |
| Verified date | March 2020 |
| Source | University of Utah |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 17 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | College of Social Work | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| University of Utah | National Center for Complementary and Integrative Health (NCCIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | Self-report affect ratings | Change from week 0 to 8 weeks | ||
| Secondary | Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use | Change from week 0 to 8 weeks |