NCT07620171

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jan 2026Oct 2027

Study Start

First participant enrolled

January 9, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

May 13, 2026

Last Update Submit

May 26, 2026

Conditions

Opioid Use DisorderPeer Recovery SupportersPeer Recovery CoachingPrimary CareBuprenorphine

Keywords

Opioid Use DisorderOUDPeer Recovery CoachPeer Recovery SupportBuprenorphineMedications for Opioid Use DisorderPrimary Care

Outcome Measures

Primary Outcomes (1)

  • OUD treatment retention

    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 Outcomes (4)

  • Self-report opioid use

    180 days

  • Buprenorphine adherence

    180 days

  • Resilience, coping, and self-efficacy

    180 days

  • Opioid urine drug screen positivity

    180 days

Study Arms (1)

Peer Support

EXPERIMENTAL
Behavioral: Peer Support

Interventions

Peer SupportBEHAVIORAL

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.

Peer Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute suicidal ideation or intent
  • Active mania or psychotic episode
  • Significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Family Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • 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.

    PMID: 38980680RESULT

  • 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.

    PMID: 35785613RESULT

  • 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.

    PMID: 33631356RESULT

  • 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.

    PMID: 39702538RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Rebecca A Harris, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family Medicine and Community Health

Study Record Dates

First Submitted

May 13, 2026

First Posted

June 2, 2026

Study Start

January 9, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)