Recruiting

Meditation

Sponsor:

University of Utah

Code:

NCT05607381

Conditions

Low Back Pain

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Meditation

Usual care

Study Details

Brief 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.

Conditions

Low Back Pain

Opioid Use

Study ID

NCT05607381

Start date

Nov 30, 2022

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness

A well-validated mindfulness meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.

experimental: Meditation

A validated meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.

active comparator: Usual Care

Patients will receive usual medical care for chronic low back pain.

Interventions

Meditation

Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.

Usual care

Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).

Primary outcome measure

  • Blood oxygenation level dependent (BOLD) signaling [ Time Frame: At baseline and at post-treatment (8 weeks) ]

Central Contacts and Locations

Central contacts

Eric Garland, PhD

858-822-4092eric.garland@socwk.utah.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Rachel Brewers

619-363-6407rbrewers@health.ucsd.edu

Principal Investigator:

Eric Garland, PhD

More Information

Sponsor

University of Utah

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Utah on 2026-07-27.