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New study aims to ease chronic pain in opioid recovery patients

NCT ID NCT06367387

Symptom relief Sponsor: Erin Winstanley Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study tests two approaches to help people with opioid use disorder and chronic pain feel better. One is a pain self-management program with coaching and peer support. The other allows flexible dosing of buprenorphine based on pain levels. 268 adults from participating clinics will take part over 12 weeks, with follow-up surveys for a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buprenorphine (also known as Suboxone, Subutex, Zubsolv)
What this could lead to
If successful, this could offer a better way to manage chronic pain in people being treated for opioid addiction, potentially improving their quality of life and treatment retention.
What could go wrong
This is a Phase 4 study with 268 participants, so results may not apply to everyone. Risks include psychological distress from discussing pain and possible side effects from higher buprenorphine doses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

273 people

The number who actually took part.

Started

May 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Adults at least 18 years old 2. Patient at a participating clinic 3. Ability to speak, read, and understand English 4. Capable of providing informed consent 5. Access to phone and/or internet 6. Documented diagnosis of Opioid Use Disorder (OUD) 7. On a stable dose of an oral or sublingual buprenorphine mono or combination product (\<4 times per day, daily dosage \<32 mg) for at least 7 days during incident new episode of care 8. Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Under 18 years of age 2. Have cancer-related pain 3. Are currently in jail, prison, or overnight facility as required by court of law or have pending legal action that could prevent participation in study activities 4. Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product 5. Currently prescribed an injectable formulation of buprenorphine 6. Pregnancy or intention to become pregnant within 4 months of enrollment 7. Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days 8. History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock 9. Currently prescribed/taking methadone or have taken methadone in the past 30 days 10. Had an intentional suicide attempt within the past 3 months Individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders will not be excluded.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pain Opioid use disorder

Contacts and locations

Locations

  • Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center

    Baltimore, Maryland, 21223, United States

  • Central City Concern (CCC)

    Portland, Oregon, 97209, United States

  • MATClinics

    Dundalk, Maryland, 21222, United States

  • OHSU Harm Reduction Bridges to Care (HRBR)

    Portland, Oregon, 97239, United States

  • OHSU Internal Medicine Clinic (IMC)

    Portland, Oregon, 97239, United States

  • Recovery Works Northwest (RWNW)

    Portland, Oregon, 97233, United States

  • UPMC Internal Medicine Recovery Engagement Program (IM-REP)

    Pittsburgh, Pennsylvania, 15219, United States

  • UPMC Latterman Family Health Center

    McKeesport, Pennsylvania, 15132, United States

  • UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC)

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC St. Margaret Family Health Center

    New Kensington, Pennsylvania, 15068, United States

  • WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)

    Morgantown, West Virginia, 26505, United States

  • WVU Crisis Support & Recovery Center

    Martinsburg, West Virginia, 25401, United States

  • Wells House

    Hagerstown, Maryland, 21740, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.