Chronic PainPhase 3NCT06387290
Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
A Phase 3 study testing Mindfulness Oriented Recovery Enhancement and Patient-Centered Chronic Pain Management Visits in people with Chronic Pain and Prescription Opioid Misuse, run by University of Utah at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Prescription Opioid Misuse, Substance-Related Disorders
- What is being tested?
- Mindfulness Oriented Recovery Enhancement and Patient-Centered Chronic Pain Management Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Feb 2025to 1 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UCSD Health
La Jolla, California, 92037
Hannah Pfeffer, MSW, 619-500-4668, hapfeffer@health.ucsd.edu
Kelly Hendrickson, MS, 619-500-4668, kehendrickson@health.ucsd.edu
- Recruiting
Rutgers University Primary Care Clinics
New Brunswick, New Jersey, 08901
Thanusha Puvananayagam, MPH, 732-235-4341, puvanath@rwjms.rutgers.edu
Nina Cooperman, PsyD
- Recruiting
University of Utah Primary Care Clinics
Salt Lake City, Utah, 84112
Hannah A Pfeffer, MSW, 619-500-4668, hapfeffer@health.ucsd.edu
Eric L Garland, PhD
About this study
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, Chemically-Induced Disorders
- Being tested
- Mindfulness Oriented Recovery Enhancement, Patient-Centered Chronic Pain Management Visits
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders, Substance-Related Disorders, Pain, Narcotic-Related Disorders, Chemically-Induced Disorders, Mental Disorders, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Oriented Recovery EnhancementBehavioural
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 VisitsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Oriented Recovery Enhancement; Behavioral: 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. Receives: Behavioral: Patient-Centered Chronic Pain Management Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
- A total sum score from 0 to 30, with higher scores indicating more severe pain and pain-related interference with life and activities
- 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.
Measured: 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 in Quality of Life will be measured from baseline through study completion using the Patient Reported Outcomes Measurement Information System (PROMIS-29) to assess physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Scores range from 4-20 in each domain, with higher scores indicating more impairment in that domain.
Measured: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Opioid Dosing
Opioid dose will be assessed from baseline through study completion by Timeline Follow Back (TLFB) interview. Opioid dose will be converted to morphine-equivalent using equianalgesic conversions.
Measured: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Opioid Craving
Opioid craving will be assessed with validated numeric rating scale items (Garland et. al, 2022) delivered by ecological momentary assessment.
Measured: Daily from baseline through month 4
PTSD Symptoms
PTSD Symptoms will be measured from baseline through study completion using the Posttraumatic Stress Disorder Checklist (PCL-5). Scores range from 0-80, with higher scores indicating overall higher PTSD symptom severity.
Measured: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Depression
Depression symptoms will be measured from baseline through study completion using the nine-item Patient Health Questionnaire (PHQ-9). Scores range from 0-27, with higher scores indicating more severe symptoms of depression.
Measured: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Generalized Anxiety
Generalized Anxiety will be measured from baseline through study completion using the Generalized Anxiety Disorder 7 (GAD-7). Scores range from 0-21, with higher scores indicating more severe symptoms of anxiety.
Measured: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start25 Feb 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid implementation-effectiveness trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University
- Responsible party
- Principal investigator, Eric Garland, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387290
- Sponsor's protocol ID
- 00172836
- Status last verified
- Jan 2026
- First submitted
- 23 Apr 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will conform to National Institutes of Health (NIH) regulations and our resource sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
- ClinicalTrials.gov ID
- NCT06387290
- Acronym / sponsor ID
- 00172836
- Conditions
- Chronic Pain, Prescription Opioid Misuse, Substance-Related Disorders, Pain, Narcotic-Related Disorders, Chemically-Induced Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Rutgers University
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Hybrid implementation-effectiveness trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits | Experimental | Behavioral: Mindfulness Oriented Recovery Enhancement, Behavioral: Patient-Centered Chronic Pain Management VisitsParticipants 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. |
| Patient-centered chronic pain management visits | Active comparator | Behavioral: Patient-Centered Chronic Pain Management VisitsParticipants will attend patient-centered chronic pain management visits led by their primary care provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Oriented Recovery EnhancementMindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative therapeutic approach. | Behavioural | Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits |
| Patient-Centered Chronic Pain Management VisitsParticipant 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). | Behavioural | Mindfulness Oriented Recovery Enhancement + Patient-centered chronic pain management visits, Patient-centered chronic pain management visits |
Primary outcome
Opioid Misuse
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
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
Chronic Pain
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
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.
6 secondary outcomes
Change in Quality of Life
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Opioid Dosing
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Opioid Craving
Time frame: Daily from baseline through month 4
PTSD Symptoms
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Depression
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Generalized Anxiety
Time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. Data sharing will conform to National Institutes of Health (NIH) regulations and our resource sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mindfulness Oriented Recovery Enhancement and Patient-Centered Chronic Pain Management Visits in people with Chronic Pain and Prescription Opioid Misuse, run by University of Utah at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Pfeffer, MSW (619-500-4668, hapfeffer@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Misuse (time frame: Change from baseline through study completion (assessed at 3-, 6-, 9-, and 12-months follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.