Recruiting
Phase 3

Mindfulness & Pain Management

Sponsor:

University of Utah

Code:

NCT06387290

Conditions

Chronic Pain

Prescription Opioid Misuse

Substance-Related Disorders

Pain

Narcotic-Related Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness Oriented Recovery Enhancement

Patient-Centered Chronic Pain Management Visits

Study Details

Brief summary:

The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.

Conditions

Chronic Pain

Prescription Opioid Misuse

Substance-Related Disorders

Pain

Narcotic-Related Disorders

Study ID

NCT06387290

Start date

Feb 25, 2025

Status verified date

Jan, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 +
  • Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment
  • Prescribed long-term opioid therapy (≥3 months)
  • Score >=3 on the Pain Enjoyment General Activity scale
  • Score >=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR patient or physician determination that risks of opioid use may outweigh the benefits of opioid use

Exclusion Criteria:

  • Chronic pain due to a cancer diagnosis
  • Active suicidal intent, schizophrenia, psychotic disorder
  • Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits

Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks, in addition to patient-centered chronic pain management visits led by their primary care provider.

active comparator: Patient-centered chronic pain management visits

Participants will attend patient-centered chronic pain management visits led by their primary care provider.

Interventions

Mindfulness Oriented Recovery Enhancement

Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative therapeutic approach.

Patient-Centered Chronic Pain Management Visits

Participant will meet with their primary care provider for patient-centered care and shared decision making while discussing their chronic pain management strategy (e.g., opioid analgesics).

Primary outcome measure

  • Opioid Misuse [ Time Frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) ]
  • Chronic Pain [ Time Frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up) ]

Central Contacts and Locations

Central contacts

Hannah Pfeffer, MSW

619-500-4668hapfeffer@health.ucsd.edu

Thanusha Puvananayagam, MPH

732.235.4341puvanath@rwjms.rutgers.edu

Locations

UCSD Health

Recruiting

La Jolla, California, United States, 92037

Contacts

Hannah Pfeffer, MSW

619-500-4668hapfeffer@health.ucsd.edu

Kelly Hendrickson, MS

619-500-4668kehendrickson@health.ucsd.edu

Rutgers University Primary Care Clinics

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Thanusha Puvananayagam, MPH

732-235-4341puvanath@rwjms.rutgers.edu

Principal Investigator:

Nina Cooperman, PsyD

University of Utah Primary Care Clinics

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Hannah A Pfeffer, MSW

619-500-4668hapfeffer@health.ucsd.edu

Principal Investigator:

Eric L Garland, PhD

More Information

Sponsor

University of Utah

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-02-03.