NCT07197801

Brief Summary

The goal of this clinical trial is to learn if receiving peer recovery support (support services provided by trained "peers" with lived experience of addiction and recovery) improves retention in medication treatment among people with opioid use disorder. The main question it aims to answer is: does peer recovery support improve retention in medication treatment for opioid use disorder? Researchers will compare two groups: (1) standard care combined with a peer recovery support program, and (2) standard care alone, to see if peer recovery support works to improve retention in medication treatment for opioid use disorder. Participants will: visit clinics as they normally would to receive standard care (medication treatment for opioid use disorder); complete two questionnaires - one when they start treatment and one 6 months later; and agree to let researchers use information from their medical record. Participants in group 1 will also be invited to meet with a peer recovery support specialist for up to 6 months.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress10%
Dec 2025Jul 2029

First Submitted

Initial submission to the registry

September 26, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 23, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

September 26, 2025

Last Update Submit

February 16, 2026

Conditions

Keywords

Medication for opioid use disorderPeer recovery support

Outcome Measures

Primary Outcomes (2)

  • 6-month treatment retention

    Data will come from the electronic health records. Retention will be defined as a participant not having a lapse in days' supply of medication for opioid use disorder treatment (buprenorphine, buprenorphine-naloxone, or naltrexone) within the 6-month follow-up period that is greater than 30 days.

    180 days from initiation of medication treatment for opioid use disorder

  • Length of time in treatment

    Data will come from the electronic health records. Length of time in treatment will be determined by summing days' supply of consecutive orders for medications for opioid use disorder treatment(buprenorphine, buprenorphine- naloxone, or naltrexone). Treatment will be considered ended if a participant has a gap in supply of more than 30 days.

    180 days from initiation of medication treatment for opioid use disorder

Study Arms (2)

Standard Care

NO INTERVENTION

Study participants will receive the standard care - medication treatment for opioid use disorder

Standard Care + Peer Recovery Support

EXPERIMENTAL

In addition to standard care (medication treatment for opioid use disorder), study participants will receive support provided by a peer recovery support specialist

Behavioral: Peer recovery support to enhance patient engagement in medication for opioid use disorder treatment

Interventions

The intervention adds a peer recovery support (PRS) program to standard outpatient medication for opioid use disorder treatment and medical care. The PRS program will entail meeting one-on-one with a peer recovery specialist over a 6-month period, who will utilize their lived experience with substance use and recovery to provide emotional, informational, instrumental, and affiliational support to participants.

Standard Care + Peer Recovery Support

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ≥ 18 years of age
  • Initiated medication for opioid use disorder treatment in past 45 days in a Geisinger outpatient clinic
  • Willing and able to give informed consent

You may not qualify if:

  • Received medication for opioid use disorder treatment at a Geisinger outpatient clinic in the 90-day period prior to the treatment initiation date
  • Not proficient in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Melissa Poulsen, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2025

First Posted

September 29, 2025

Study Start

December 23, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

July 31, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

A dataset from the randomized controlled trial (RCT) of U.S. adult patients initiating medication for opioid use disorder treatment will be shared. The data will be obtained from electronic health records (EHRs) and two assessments completed by study participants at baseline and 6-months follow-up. Data elements include each patients' study group assignment (standard care (SC) or SC plus the peer recovery support program), study outcomes, demographic and clinical covariates, and potential mediating and moderating variables. A second dataset from the subset of individuals randomized to SC+PRS will be shared. This data will come from a combination of EHRs, study logs, and assessments completed by patients. Data includes variables pertaining to patient's degree of engagement and satisfaction with the PRS program.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be released when study results are published, or at the end of the granting period, whichever comes first. Data will be permanently archived.
Access Criteria
De-identified datasets and meta-data will be available to access via the National Addiction \& HIV Data Archive Program (NAHDAP) repository. Accessing data will require user registration and agreement to the data repository's terms of use, which require users to make no attempt to identify human subjects, cite the data/DOI, and not redistribute the data without NAHDAP written permission.

Locations