protocolSection identificationModule nctId: NCT06367387, orgStudyIdInfo id: STUDY23080191, secondaryIdInfos id: RM1DA055311, type: NIH, link: https://reporter.nih.gov/quickSearch/RM1DA055311, briefTitle: Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment, acronym: TREETOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jessica Merlin, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: 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. 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., conditionsModule conditions: Opioid Use Disorder, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 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)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 460, type: ESTIMATED, armsInterventionsModule interventions name: Patient-Oriented Dosing (POD), interventions name: Pain Self-Management (PSM), interventions name: Usual Care, interventions name: Standard Buprenorphine Dosing Condition, outcomesModule primaryOutcomes measure: Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline, primaryOutcomes measure: Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline, secondaryOutcomes measure: Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline, secondaryOutcomes measure: Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline, secondaryOutcomes measure: Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline, secondaryOutcomes measure: Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline, secondaryOutcomes measure: Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline, secondaryOutcomes measure: Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Outpatient Addiction Treatment Services (OATS), city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Research Team, role: CONTACT, email: HFitzsimons@som.umaryland.edu, contacts name: Eric Weintraub, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center, city: Baltimore, state: Maryland, zip: 21223, country: United States, contacts name: Research Team, role: CONTACT, email: HFitzsimons@som.umaryland.edu, contacts name: Eric Weintraub, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Research Team, role: CONTACT, email: TREETOP@pitt.edu, contacts name: Sophia Purekal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Wells House, city: Hagerstown, state: Maryland, zip: 21740, country: United States, contacts name: Research Team, role: CONTACT, email: HFitzsimons@som.umaryland.edu, contacts name: Eric Weintraub, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.64176, lon: -77.71999, locations facility: Central City Concern (CCC), city: Portland, state: Oregon, zip: 97209, country: United States, contacts name: Research Team, role: CONTACT, email: treetop@ohsu.edu, contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Recovery Works Northwest (RWNW), city: Portland, state: Oregon, zip: 97233, country: United States, contacts name: Research Team, role: CONTACT, email: treetop@ohsu.edu, contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: OHSU Harm Reduction Bridges to Care (HRBR), city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Research Team, role: CONTACT, email: treetop@ohsu.edu, contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: OHSU Internal Medicine Clinic (IMC), city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Research Team, role: CONTACT, email: treetop@ohsu.edu, contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: UPMC Latterman Family Health Center, city: McKeesport, state: Pennsylvania, zip: 15132, country: United States, contacts name: Research Team, role: CONTACT, phone: 412-852-8499, email: TREETOP@pitt.edu, contacts name: Jessica Merlin, MD, PhD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.34785, lon: -79.86422, locations facility: UPMC St. Margaret Family Health Center, city: New Kensington, state: Pennsylvania, zip: 15068, country: United States, contacts name: Research Team, role: CONTACT, phone: 412-852-8499, email: TREETOP@pitt.edu, contacts name: Jessica Merlin, MD, PhD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.56979, lon: -79.76477, locations facility: UPMC Internal Medicine Recovery Engagement Program (IM-REP), city: Pittsburgh, state: Pennsylvania, zip: 15219, country: United States, contacts name: Research Team, role: CONTACT, phone: 412-852-8499, email: TREETOP@pitt.edu, contacts name: Jessica Merlin, MD, PhD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: WVU Crisis Support & Recovery Center, city: Martinsburg, state: West Virginia, zip: 25401, country: United States, contacts name: Research Team, role: CONTACT, phone: 304-290-9159, email: lychoo@hsc.wvu.edu, contacts name: Dorothy Van Oppen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.45621, lon: -77.96389, locations facility: WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT), city: Morgantown, state: West Virginia, zip: 26505, country: United States, contacts name: Research Team, role: CONTACT, phone: 304-290-9159, email: lychoo@hsc.wvu.edu, contacts name: Dorothy Van Oppen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62953, lon: -79.9559, hasResults: False