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Peer Recovery Support for Opioid Use Disorder Treatment Retention

26. mai 2026 oppdatert av: Rebecca Harris, University of Pennsylvania

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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Penn Family Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Peer Support
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
OUD treatment retention
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-report opioid use
Tidsramme: 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
Tidsramme: 180 days
Assessed using the Brief Medication Questionnaire (self-report).
180 days
Resilience, coping, and self-efficacy
Tidsramme: 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
Tidsramme: 180 days
Proportion of urine drug screens positive for opioids, obtained at routine clinical visits throughout the study period.
180 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Pennsylvania

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Etterforskere

  • Hovedetterforsker: Rebecca A Harris, MD, University of Pennsylvania

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. januar 2026

Primær fullføring (Antatt)

31. oktober 2027

Studiet fullført (Antatt)

31. oktober 2027

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. mai 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 858768
  • K23DA054157 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared. This is a small pilot feasibility study involving participants with opioid use disorder, a population for whom confidentiality protections are particularly important given the sensitivity of substance use data and potential risks of stigma and discrimination. The sample is too small for effective de-identification of individual-level data. Aggregate descriptive findings will be reported in publications.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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