NCT06387290

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3 chronic-pain

Timeline
25mo left

Started Feb 2025

Longer than P75 for phase_3 chronic-pain

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Feb 2025May 2028

First Submitted

Initial submission to the registry

April 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

April 23, 2024

Last Update Submit

January 30, 2026

Conditions

Opioid-Related DisordersNeurologic ManifestationsChronic PainPrescription Opioid MisuseSubstance-Related DisordersPainNarcotic-Related DisordersChemically-Induced DisordersMental Disorders

Outcome Measures

Primary Outcomes (2)

  • Opioid Misuse

    Opioid misuse as evidenced by triangulated aggregate of self-reported Current Opioid Misuse Measure and/or interview via Addiction Behaviors Checklist and/or urine screen

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • Chronic Pain

    Change in Chronic pain will be measured from baseline through study completion using the Pain, Enjoyment of Life, and General Activity Scale (PEG). Scoring can be determined in one of two ways: 1. A total sum score from 0 to 30, with higher scores indicating more severe pain and pain-related interference with life and activities 2. Dividing the sum of responses to all three items by 3 to get the mean score on a scale of 0-10, with higher scores indicating more severe pain and pain-related interference with life and activities.

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

Secondary Outcomes (6)

  • Change in Quality of Life

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • Opioid Dosing

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • Opioid Craving

    Daily from baseline through month 4

  • PTSD Symptoms

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • Depression

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • +1 more secondary outcomes

Other Outcomes (4)

  • Decentering

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • Mindful Reappraisal of Pain Sensations

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • Savoring

    Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)

  • +1 more other outcomes

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Mindfulness Oriented Recovery EnhancementBehavioral: Patient-Centered Chronic Pain Management Visits

Patient-centered chronic pain management visits

ACTIVE COMPARATOR

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

Behavioral: Patient-Centered Chronic Pain Management Visits

Interventions

Patient-Centered Chronic Pain Management VisitsBEHAVIORAL

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).

Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visitsPatient-centered chronic pain management visits
Mindfulness Oriented Recovery EnhancementBEHAVIORAL

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCSD Health

La Jolla, California, 92037, United States

RECRUITING

Rutgers University Primary Care Clinics

New Brunswick, New Jersey, 08901, United States

RECRUITING

University of Utah Primary Care Clinics

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Chronic PainOpioid-Related DisordersSubstance-Related DisordersPainNarcotic-Related DisordersChemically-Induced DisordersMental DisordersNeurologic Manifestations

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNervous System Diseases

Central Study Contacts

Hannah Pfeffer, MSW

CONTACT

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

Thanusha Puvananayagam, MPH

CONTACT

732.235.4341puvanath@rwjms.rutgers.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigators, study staff, and statistician will be blinded to treatment condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Hybrid implementation-effectiveness trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Principal Investigator

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 29, 2024

Study Start

February 25, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Data sharing will conform to National Institutes of Health (NIH) regulations and our resource sharing plan

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
At the time with publication of the primary outcome results

Locations

US(3)