Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
NCT ID: NCT06367387
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
268 participants
INTERVENTIONAL
2024-05-28
2026-10-31
Brief Summary
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The research study is testing two different interventions along with usual clinical care:
1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain.
2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.
The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation.
There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Usual Care + Standard Buprenorphine Dosing
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions.
Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Usual Care
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions.
Standard Buprenorphine Dosing Condition
Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Usual Care + Patient-Oriented Dosing (POD)
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions.
Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
Patient-Oriented Dosing (POD)
Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone to treat individuals with both OUD and chronic pain. It is based on existing evidence related to buprenorphine for the treatment of pain. POD allows participants to receive a daily dosage of bup up to 32mg/day, split up to 4 times per day.
A response-guided dosing strategy, in which buprenorphine or buprenorphine/naloxone doses will be titrated based on a participant response, will be used to identify a dose regimen that is safe and effective. Due to inter-individual pharmacokinetic/pharmacodynamic variability, POD dosing will be individualized based on a participant's pain intensity and interference.
Usual Care
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions.
Pain Self-Management (PSM) + Standard Buprenorphine Dosing
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions.
Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Pain Self-Management (PSM)
Pain self-management (PSM) is a manualized behavioral intervention consisting of 12 sessions, comprising 6 group and 6 individual sessions. The first session will be individual, followed by a group session, and then alternating weekly for the remainder of the intervention.
Individual sessions will be led by a staff Interventionist trained in the pain self-management intervention. The interventionist will guide participants through a PSM study manual, providing education, teaching associated skills, and assisting with goal setting.
Group sessions will be led by a Peer Facilitator who has experience with chronic pain, opioid use disorder, and buprenorphine treatment. These sessions will not have specific content but will serve as supportive forums for participants to discuss their experiences with the intervention, share tips for managing chronic pain, and provide mutual support.
Standard Buprenorphine Dosing Condition
Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)
Pain self-management (PSM) is a manualized behavioral intervention tailored for patients in outpatient-based addiction treatment (OBAT) programs. PSM consists of 12 intervention sessions, comprising 6 group sessions and 6 individual sessions.
Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone for treating participants with both opioid use disorder (OUD) and chronic pain. POD allows titration of buprenorphine or buprenorphine/naloxone dosing up to 32mg/day, split into four doses per day, based on the participant's pain level.
Patient-Oriented Dosing (POD)
Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone to treat individuals with both OUD and chronic pain. It is based on existing evidence related to buprenorphine for the treatment of pain. POD allows participants to receive a daily dosage of bup up to 32mg/day, split up to 4 times per day.
A response-guided dosing strategy, in which buprenorphine or buprenorphine/naloxone doses will be titrated based on a participant response, will be used to identify a dose regimen that is safe and effective. Due to inter-individual pharmacokinetic/pharmacodynamic variability, POD dosing will be individualized based on a participant's pain intensity and interference.
Pain Self-Management (PSM)
Pain self-management (PSM) is a manualized behavioral intervention consisting of 12 sessions, comprising 6 group and 6 individual sessions. The first session will be individual, followed by a group session, and then alternating weekly for the remainder of the intervention.
Individual sessions will be led by a staff Interventionist trained in the pain self-management intervention. The interventionist will guide participants through a PSM study manual, providing education, teaching associated skills, and assisting with goal setting.
Group sessions will be led by a Peer Facilitator who has experience with chronic pain, opioid use disorder, and buprenorphine treatment. These sessions will not have specific content but will serve as supportive forums for participants to discuss their experiences with the intervention, share tips for managing chronic pain, and provide mutual support.
Interventions
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Patient-Oriented Dosing (POD)
Patient-oriented dosing (POD) is a promising approach to using buprenorphine or buprenorphine/naloxone to treat individuals with both OUD and chronic pain. It is based on existing evidence related to buprenorphine for the treatment of pain. POD allows participants to receive a daily dosage of bup up to 32mg/day, split up to 4 times per day.
A response-guided dosing strategy, in which buprenorphine or buprenorphine/naloxone doses will be titrated based on a participant response, will be used to identify a dose regimen that is safe and effective. Due to inter-individual pharmacokinetic/pharmacodynamic variability, POD dosing will be individualized based on a participant's pain intensity and interference.
Pain Self-Management (PSM)
Pain self-management (PSM) is a manualized behavioral intervention consisting of 12 sessions, comprising 6 group and 6 individual sessions. The first session will be individual, followed by a group session, and then alternating weekly for the remainder of the intervention.
Individual sessions will be led by a staff Interventionist trained in the pain self-management intervention. The interventionist will guide participants through a PSM study manual, providing education, teaching associated skills, and assisting with goal setting.
Group sessions will be led by a Peer Facilitator who has experience with chronic pain, opioid use disorder, and buprenorphine treatment. These sessions will not have specific content but will serve as supportive forums for participants to discuss their experiences with the intervention, share tips for managing chronic pain, and provide mutual support.
Usual Care
Usual care, or "treatment as usual," refers to the standard of care that participants receive at their office-based addiction treatment (OBAT) clinic. This includes discussing issues related to chronic pain and opioid use (e.g., buprenorphine) with their provider and receiving clinical care for these conditions.
Standard Buprenorphine Dosing Condition
Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.
Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Erin Winstanley
OTHER
Responsible Party
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Erin Winstanley
Professor
Principal Investigators
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Erin L Winstanley, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center
Baltimore, Maryland, United States
MATClinics
Dundalk, Maryland, United States
Wells House
Hagerstown, Maryland, United States
Central City Concern (CCC)
Portland, Oregon, United States
Recovery Works Northwest (RWNW)
Portland, Oregon, United States
OHSU Harm Reduction Bridges to Care (HRBR)
Portland, Oregon, United States
OHSU Internal Medicine Clinic (IMC)
Portland, Oregon, United States
UPMC Latterman Family Health Center
McKeesport, Pennsylvania, United States
UPMC St. Margaret Family Health Center
New Kensington, Pennsylvania, United States
UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC)
Pittsburgh, Pennsylvania, United States
UPMC Internal Medicine Recovery Engagement Program (IM-REP)
Pittsburgh, Pennsylvania, United States
WVU Crisis Support & Recovery Center
Martinsburg, West Virginia, United States
WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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STUDY23080191
Identifier Type: -
Identifier Source: org_study_id
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