Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment

NCT06367387 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY23080191RM1DA055311
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 13

Brief Summary

This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv). The research study is testing two different interventions along with usual clinical care:

1. 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. 2.Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.

Conditions

Opioid Use Disorder; Chronic Pain

Keywords

pain self-management; buprenorphine

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline

  The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. That is, a person has more problems with pain hindering activities. By comparison, a pain interference T-score of 40 is one SD better than average. Change = 3 month score - baseline score

  Baseline, 3 Months

Secondary Outcomes (7)

• Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline

  Baseline, 3 Months

• Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline

  Baseline, 3 Months

• Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline

  3 Months

• Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline

  3 Months, 6 Months, 9 Months, 12 Months

• Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline

  Baseline, 3 Months

Study Arms (4)

Usual Care + Standard Buprenorphine Dosing

ACTIVE COMPARATOR

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.

Behavioral: Usual Care; Drug: Standard Buprenorphine Dosing Condition

Usual Care + Patient-Oriented Dosing (POD)

EXPERIMENTAL

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.

Drug: Patient-Oriented Dosing (POD); Behavioral: Usual Care

Pain Self-Management (PSM) + Standard Buprenorphine Dosing

EXPERIMENTAL

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.

Behavioral: Pain Self-Management (PSM); Drug: Standard Buprenorphine Dosing Condition

Pain Self-Management (PSM) + Patient-Oriented Dosing (POD)

EXPERIMENTAL

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.

Drug: Patient-Oriented Dosing (POD); Behavioral: Pain Self-Management (PSM)

Interventions

Standard Buprenorphine Dosing Condition DRUG

Participants will continue standard buprenorphine or buprenorphine/naloxone dosing as part of normal clinical care.

Pain Self-Management (PSM) + Standard Buprenorphine Dosing; Usual Care + Standard Buprenorphine Dosing

Patient-Oriented Dosing (POD) DRUG

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) + Patient-Oriented Dosing (POD); Usual Care + Patient-Oriented Dosing (POD)

Pain Self-Management (PSM) BEHAVIORAL

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.

Pain Self-Management (PSM) + Patient-Oriented Dosing (POD); Pain Self-Management (PSM) + Standard Buprenorphine Dosing

Usual Care BEHAVIORAL

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.

Usual Care + Patient-Oriented Dosing (POD); Usual Care + Standard Buprenorphine Dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Adults at least 18 years old
• Patient at a participating clinic
• Ability to speak, read, and understand English
• Capable of providing informed consent
• Access to phone and/or internet
• Documented diagnosis of Opioid Use Disorder (OUD)
• 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
• Have high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Under 18 years of age
• Have cancer-related pain
• 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
• Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
• Currently prescribed an injectable formulation of buprenorphine
• Pregnancy or intention to become pregnant within 4 months of enrollment
• Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days
• History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock
• Currently prescribed/taking methadone or have taken methadone in the past 30 days
• 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.

Sponsors & Collaborators

• Erin Winstanley: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (13)

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

Baltimore, Maryland, 21223, United States

Location

MATClinics

Dundalk, Maryland, 21222, United States

Location

Wells House

Hagerstown, Maryland, 21740, United States

Location

Central City Concern (CCC)

Portland, Oregon, 97209, United States

Location

Recovery Works Northwest (RWNW)

Portland, Oregon, 97233, United States

Location

OHSU Harm Reduction Bridges to Care (HRBR)

Portland, Oregon, 97239, United States

Location

OHSU Internal Medicine Clinic (IMC)

Portland, Oregon, 97239, United States

Location

UPMC Latterman Family Health Center

McKeesport, Pennsylvania, 15132, United States

Location

UPMC St. Margaret Family Health Center

New Kensington, Pennsylvania, 15068, United States

Location

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

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Internal Medicine Recovery Engagement Program (IM-REP)

Pittsburgh, Pennsylvania, 15219, United States

Location

WVU Crisis Support & Recovery Center

Martinsburg, West Virginia, 25401, United States

Location

WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin L Winstanley, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be stratified by recruitment clinic and dose of buprenorphine at enrollment (≤16 mg vs \>16 mg) and randomized in 2x2 factorial design: 1) either to PSM or Usual Care, and then 2) either to POD or standard buprenorphine dosing. The randomization schema will be generated by the TREETOP Data Core using a stratified permuted block design and will be integrated into the web-based data collection and management system (REDCap).

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 16, 2024
• Study Start: May 28, 2024
• Primary Completion: February 9, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified data will be made available within 18 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Access to trial IPD may be made available to individuals that submit a request along with the required documents to the IMPOWR data committee. Data access requires approval by the IMPOWR data committee and the individual must agree to comply with the data sharing policies of IMPOWR and HEAL.

Locations

US (13)