- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06696066
PEERS Pilot: Peer Recovery Support Program to Support Engagement in Medication for Opioid Use Disorder (PEERS)
Pilot Evaluation of a Peer Recovery Support Program Adapted to Target Retention in Clinic-based Medication for Opioid Use Disorder Treatment
The goal of this pilot study is to evaluate the feasibility and acceptability of implementing a peer recovery support program to support patient engagement in medication treatment for opioid use disorder (MOUD). The program, entitled "Promoting Enhanced Engagement through Recovery Support" (PEERS) was developed in collaboration with community and clinical partners for the MOUD outpatient setting. Information gathered during this pilot study will inform refinements to the program and study components for a future clinical trial that will evaluate the effectiveness of the peer recovery support program in increasing patient retention in MOUD.
The investigators will recruit 12 participants to the pilot study, all of whom will receive the PEERS program. The study will take place in Geisinger outpatient addiction treatment clinics in northeast Pennsylvania. Patients initiating MOUD treatment at one of the clinics will be eligible for participation, and will be recruited via email, patient portal messages, and phone. Each participant will receive the PEERS program, entailing regular sessions with a Certified Recovery Specialist (CRS) for 6 months. Participants will also be asked to complete assessments at baseline and 12 weeks and will be invited to provide qualitative feedback on their experience with the program through an interview conducted between 8-12 weeks. As the focus of the pilot pertains to the feasibility and acceptability of the program and the study components, study outcomes focus on participant engagement in and acceptance of the program, CRS fidelity to the program, barriers to implementation, and feasibility of data collection.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Geisinger Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult ≥ 18 years of age
- Initiated medication for opioid use disorder at a Geisinger outpatient addiction treatment clinic within the past 45 days
- Willing to participate in the Peer Recovery Support program
- Able and willing to provide consent
Exclusion Criteria:
- Received medication for opioid use disorder at a Geisinger outpatient addiction treatment clinic in the 90 days prior to the treatment initiation date
- Not proficient in English
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 Recovery Support Pilot Program Implementation and Assessment
Participants will be offered services from a certified recovery specialist (CRS; i.e., the Peer Recovery Support program).
This will entail a CRS meeting one-on-one with the patient at regular intervals (e.g., weekly) to provide support to the participant for a 6-month period.
CRS services are patient-centered and driven by a patient's own recovery goals, thus the frequency, timing, duration, modality (in-person, phone), and location of meetings (in the clinic or in a community setting such as a coffeeshop) are flexible and determined collaboratively by the CRS and patient.
|
The Peer Recovery Support program will be delivered by a certified recovery specialist (CRS) over the course of 6-months.
The CRS will provide supportive care to the participant during their initial 6-months of MOUD treatment to increase patient engagement in their treatment.
The CRS may provide emotional support; help participants to identify their recovery assets, goals, and barriers; guide participants in creating a recovery plan; help participants to increase their coping skills; and assist participants in connecting to community and recovery resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Participant Engagement in the Peer Recovery Support Program
Time Frame: Baseline to 12 weeks
|
Percent of participants who attended at least 2 sessions with the Certified Recovery Specialist
|
Baseline to 12 weeks
|
|
Acceptability - Participant Alliance With Certified Recovery Specialist
Time Frame: 12 weeks
|
Participants' average scores for the Scales for Participant Alliance with Recovery Coach (SPARC-2); score can range from 1-5 and a high score indicates greater satisfaction with the CRS.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Feasibility of Assessment Completion
Time Frame: Baseline
|
Percent of participants who completed the baseline assessment
|
Baseline
|
|
Feasibility - Feasibility of Assessment Completion
Time Frame: 12 weeks
|
Percent of participants who completed the follow-up assessment
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melissa Poulsen, PhD, Geisinger Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2024-0862
- 1R61DA059880 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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
-
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
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)CompletedSubstance Use Disorder | Opioid Use Disorder | Heroin 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
-
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
-
University of ChicagoCommunity Outreach Intervention Projects; Cook County Sheriff Office; Cook County... and other collaboratorsRecruiting
-
Albert Einstein College of MedicineNational Institute on Drug Abuse (NIDA); Pfizer; National Institutes of Health...CompletedTobacco Use Disorder | Opioid-use DisorderUnited States
-
Indiana UniversityCompletedOpioid Use | Opioid-use DisorderUnited States
Clinical Trials on PRS Program
-
Integra LifeSciences CorporationCompletedReconstructive Surgical ProceduresUnited Kingdom, Italy, Switzerland
-
Tela Bio IncMCRARecruitingReconstructive Surgical ProceduresUnited States
-
Tela Bio IncRecruitingBreast ReconstructionUnited States
-
Pieris Pharmaceuticals GmbHFGK Clinical Research GmbH; Nuvisan Pharma Services; EUROCALIN ConsortiumCompleted
-
Pieris Australia Pty LtdCompleted
-
Pieris Pharmaceuticals GmbHFGK Clinical Research GmbHCompletedAnemia of Chronic Kidney DiseaseCzechia, Germany
-
Pieris Australia Pty LtdCompletedStudy of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy SubjectsHealthy SubjectsAustralia
-
Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCoronary Artery DiseaseUnited States
-
Pieris Pharmaceuticals, Inc.CompletedHER2-positive Breast Cancer | HER2-positive Gastric Cancer | HER2-positive Bladder Cancer | HER2-positive Solid TumorUnited States
-
Monash UniversityRecruitingCardiovascular Diseases | Type 2 Diabetes Mellitus (T2DM)Australia