NCT05607381NARecruiting
Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain
University of Utah
Start Date
11/30/2022
Completion Date
6/30/2027
Summary
The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.
Detailed Description
The trial is powered to detect an effect on the primary outcome with 150 participants with complete pre-post data; additional participants are enrolled to account for approximately 25% attrition.
Eligibility Criteria
Age Range: 18 years to 65 years
Inclusion Criteria:
1\) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain ≥3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for ≥3 months.
Exclusion Criteria:
1\) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.
Interventions
BEHAVIORAL
Meditation
OTHER
Usual care
Conditions
Low Back PainOpioid Use
Locations
University of California, San Diego
La Jolla, California 92093
United States
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah 84108
United States