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Improving pain management for people on buprenorphine

Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial

Phase 4 Interventional University of Pittsburgh · NCT06367387

This study is testing two new ways to help people with chronic pain who are taking buprenorphine feel better by working with coaches and adjusting their medication based on their pain levels.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Pittsburgh Academic / other
Locations13 sites (Baltimore, Maryland and 12 other locations)
Trial IDNCT06367387 on ClinicalTrials.gov

What this trial studies

This study aims to enhance chronic pain treatment in individuals taking buprenorphine by testing two interventions alongside standard care. The first intervention is Pain Self-Management (PSM), where participants work with a trained coach and peer to develop effective pain management strategies. The second intervention is Patient-Oriented Dosing (POD), which involves adjusting buprenorphine doses based on the patient's pain levels. The study will last for 12 weeks, with participants completing surveys over a year to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of opioid use disorder and high-impact chronic pain.

Not a fit: Patients who do not have chronic pain or are not currently on buprenorphine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients with opioid use disorder.

How similar studies have performed: Other studies have shown promise in similar approaches to pain management and opioid treatment, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 from participating clinics
2. Ability to speak, read, and understand English
3. Capable of providing informed consent
4. Access to phone and/or internet
5. Documented diagnosis of Opioid Use Disorder (OUD)
6. Within \<180 days (6 months) of a new treatment episode, ideally within 90 days (3 months)

   * New treatment episode is defined as not having received prescribed buprenorphine treatment in an outpatient setting for OUD in the prior 30 days (1 month)
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
8. History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock

Individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders will not be excluded.

Where this trial is running

Baltimore, Maryland and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Opioid Use DisorderChronic Painpain self-managementbuprenorphine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.