- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07620171
Peer Recovery Support for Opioid Use Disorder Treatment Retention
Reducing OUD Treatment Dropout: Development and Pilot Test of a Peer Recovery Support Intervention in Primary Care
The goal of this clinical trial is to learn whether adding peer recovery support services to standard opioid use disorder (OUD) treatment in primary care helps patients stay in treatment longer. The main question it seeks to answer is whether it is feasible to deliver a peer recovery support intervention alongside medication-assisted treatment (buprenorphine) in a Philadelphia primary care clinic.
Participants will receive standard OUD treatment (buprenorphine) combined with peer recovery support services for 180 days. They will attend study visits at baseline, weekly for the first 2 weeks, then every 2 weeks, then monthly, and complete assessments about substance use, medication adherence, self-efficacy, resilience, and coping. Participants will also take part in brief periodic interviews about their experience with peer support.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Opioid use disorder (OUD) is a chronic, relapsing condition associated with substantial morbidity, mortality, and social burden. Buprenorphine, delivered in primary care settings, is an evidence-based treatment for OUD, yet treatment dropout remains a critical barrier to recovery. Many patients disengage during the early weeks following induction, before buprenorphine has had the opportunity to stabilize their condition. Peer recovery support (PRS) services, provided by individuals with lived experience of addiction and recovery, represent a promising strategy to improve retention, but the evidence base for optimized peer interventions in primary care OUD treatment remains limited.
The peer intervention evaluated in this study was developed through a systematic optimization process conducted in partnership with OUD, peer, and implementation experts, with extensive input from patients, practitioners, and community stakeholders. Intervention design drew on surveys and qualitative studies of Philadelphia-region OUD treatment programs with existing peer support services, as well as best practices from community health worker models in other chronic disease settings. Component elements, including peer qualifications, supervision structure, training curriculum, caseload size, scope of services, and care team integration, were systematically evaluated and refined prior to the pilot.
The resulting intervention is organized around five core structural elements: (1) clinically integrated supervision with structured case review; (2) standardized recruitment and hiring practices emphasizing empathy, problem-solving capacity, and community engagement; (3) a competency-based training curriculum covering psychosocial support, crisis response, stigma, interprofessional ethics, social determinants of health, and system navigation; (4) stage-tailored peer-patient contact, with intensive engagement during the high-dropout early induction period transitioning to stabilization-focused support as treatment progresses; and (5) active peer wellness practices to mitigate compassion fatigue and burnout.
This pilot study will evaluate the feasibility, acceptability, and operational implementation of the intervention within primary care-based buprenorphine treatment programs and generate data to inform a future randomized controlled trial.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Penn Family Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of opioid use disorder (OUD)
- Currently receiving or initiating buprenorphine treatment from a primary care physician
- Able to communicate in English
- Access to a phone
- Able and willing to provide written informed consent
Exclusion Criteria:
- Acute suicidal ideation or intent
- Active mania or psychotic episode
- Significant cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer Support
|
Peer recovery support services delivered by trained, certified peers with lived experience of opioid use disorder, added to standard medication-assisted treatment (buprenorphine) in a primary care setting.
Peer services are structured around three stages of OUD treatment (initial engagement, early treatment, and stable treatment) with contact intensity tailored to dropout risk at each stage (approximately 2 contact hours/week during initial engagement).
Contact modalities include in-office meetings, phone calls, texts, and appointment reminders.
Peers are supervised and integrated as full members of the clinical care team.
The intervention was developed with input from OUD, peer, and implementation experts and informed by qualitative and survey data from Philadelphia-region OUD treatment programs.
Caseload: approximately 15 patients per peer.
Duration: 180 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OUD treatment retention
Time Frame: 180 days
|
Retention in OUD treatment measured as time in days from treatment initiation (buprenorphine induction) to dropout (unplanned treatment termination) or treatment completion over the 180-day study period.
|
180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-report opioid use
Time Frame: 180 days
|
Assessed using an abbreviated 30-day Time-Line Follow-Back (TLFB) instrument capturing self-reported opioid use at each study visit.
|
180 days
|
|
Buprenorphine adherence
Time Frame: 180 days
|
Assessed using the Brief Medication Questionnaire (self-report).
|
180 days
|
|
Resilience, coping, and self-efficacy
Time Frame: 180 days
|
A 30-item composite questionnaire combining three patient-centered outcome domains to minimize participant burden.
Section 1 (Resilience, 10 items) uses a 5-point Likert scale rating the past month, with 4 items reverse-scored; scores range from 10 to 50, with higher scores indicating greater resilience.
Section 2 (Coping Strategies, 10 items adapted from the Brief COPE) uses a 4-point scale rating frequency of coping strategy use, including a substance use item; scores range from 10 to 40, with higher scores indicating greater frequency of coping strategy use.
Section 3 (Abstinence Self-Efficacy, 10 items adapted from the Alcohol Abstinence Self-Efficacy Scale) uses a 5-point confidence scale assessing ability to remain opioid-free across situational triggers over the past week; scores range from 10 to 50, with higher scores indicating greater confidence in maintaining opioid abstinence.
|
180 days
|
|
Opioid urine drug screen positivity
Time Frame: 180 days
|
Proportion of urine drug screens positive for opioids, obtained at routine clinical visits throughout the study period.
|
180 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca A Harris, MD, University of Pennsylvania
Publications and helpful links
General Publications
- Bao Y, Zhang H, Hutchings K, Harris RA, Calderbank T, Schackman BR. Medicaid-Covered Peer Support Services Used by Enrollees With Opioid Use Disorder. JAMA Netw Open. 2024 Jul 1;7(7):e2420737. doi: 10.1001/jamanetworkopen.2024.20737.
- Harris RA, Campbell K, Calderbank T, Dooley P, Aspero H, Maginnis J, O'Donnell N, Coviello D, French R, Bao Y, Mandell DS, Bogner HR, Lowenstein M. Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model. Healthc (Amst). 2022 Sep;10(3):100641. doi: 10.1016/j.hjdsi.2022.100641. Epub 2022 Jul 2.
- Harris RA, Mandell DS, Kampman KM, Bao Y, Campbell K, Cidav Z, Coviello DM, French R, Livesey C, Lowenstein M, Lynch KG, McKay JR, Oslin DW, Wolk CB, Bogner HR. Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol. Contemp Clin Trials. 2021 Apr;103:106325. doi: 10.1016/j.cct.2021.106325. Epub 2021 Feb 22.
- Harris RA, Kearney M, Keddem S, Calderbank T, Tomczuk L, Clapp J, Perrone J, Kranzler HR, Long JA, Mandell DS. Organization of primary care and early MOUD discontinuation. Addict Sci Clin Pract. 2024 Dec 19;19(1):96. doi: 10.1186/s13722-024-00527-w.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 858768
- K23DA054157 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opioid Use Disorder
-
Wake Forest University Health SciencesUniversity of Chicago; Rogers Behavioral Health; University of California Santa...RecruitingSubstance Use | Methamphetamine-dependence | Opioid Use | Opioid-use Disorder | Cocaine Use Disorder | Cocaine Use | Methamphetamine AbuseUnited States
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)CompletedSubstance Use Disorder | Opioid Use Disorder | Heroin Use DisorderUnited States
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
Vanderbilt University Medical CenterCompletedOpioid Use | Opioid-use DisorderUnited States
-
Center for Progressive Recovery, LLCNational Institute on Drug Abuse (NIDA); Yale UniversityCompletedCriminal Behavior | Opioid Use Disorder, Moderate | Opioid Use Disorder, SevereUnited States
-
Albert Einstein College of MedicineNational Institute on Drug Abuse (NIDA); Pfizer; National Institutes of Health...CompletedTobacco Use Disorder | Opioid-use DisorderUnited States
-
Indivior Inc.CompletedOpioid Use Disorder, Moderate | Opioid Use Disorder, SevereUnited States
-
Brigham and Women's HospitalOhio State UniversityActive, not recruitingOpioid Dependence | Opioid Use | Opioid-use DisorderUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Columbia University; Weill Medical College... and other collaboratorsEnrolling by invitationOpioid Use | Opioid Court Model | Medication to Treat Opioid Use DisorderUnited States
-
Indiana UniversityCompletedOpioid Use | Opioid-use DisorderUnited States
Clinical Trials on Peer Support
-
Samantha AnthonyHeart and Stroke Foundation of CanadaNot yet recruitingHeart Failure | Cardiomyopathies | Young Adults | Peer Support | Fontan Procedure | Mentorship | Heart Transplant Recipient | Peer Support and Chronic DiseaseCanada
-
Makerere UniversityUniversity of Bergen; Centre MurazUnknownMalnutrition | Neurologic Deficits | Poor Performance Status | Infections, Hospital | Mixed Behavior and Emotional DisorderUganda
-
Northwestern UniversityCompletedDepressionUnited States
-
University of Eastern FinlandSocial Insurance Institution, Finland; Finnish Cultural FoundationRecruiting
-
Lighthouse TrustUniversity of North Carolina, Chapel Hill; World Health Organization; Kamuzu... and other collaboratorsUnknown
-
Jinan University GuangzhouGuangzhou Sport UniversityCompletedObesity Prevention | Depression - Major Depressive Disorder | Psychological Well BeingChina
-
Universitätsklinikum Hamburg-EppendorfUniversity of UlmActive, not recruitingSevere Mental Health Condition With Indication of Hospital AdmissionGermany
-
Hospices Civils de LyonRecruiting
-
pınar doganCompletedChronic Kidney Disease Requiring HemodialysisTurkey
-
MRC/UVRI and LSHTM Uganda Research UnitKarolinska Institutet; European and Developing Countries Clinical Trials Partnership... and other collaboratorsCompleted