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Peer Recovery Support Services for Individuals in Recovery Residences on MOUD

Primary Purpose

Opioid Use Disorder, Substance Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment as Usual (TAU) (Arm 1)
Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2)
Sponsored by
Potomac Health Foundations
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Medications for Opioid Use Disorder, Opioid Use Disorder, Recovery Residence, Peer Support, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18+ (inclusive); meets diagnostic criteria for OUD; residing at a RR affiliated with this study; seeking treatment with and successfully inducted onto MOUD (i.e., XR-NTX, SL-BUP, XR-BUP, or methadone); English speaking; willing and able to provide informed consent. Exclusion Criteria: Currently receiving formalized PRSS outside of the study (not applicable to peer support typical of sponsorship in 12-step mutual support programs or informal support through RRs).

Sites / Locations

  • Maryland Treatment CentersRecruiting
  • Maryland Treatment Centers/Avery Road Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1 Title: Treatment as Usual (TAU)

Arm 2 Title: Peer Recovery Support Services (PRSS) + TAU

Arm Description

Arm 1: Treatment as Usual (TAU): The treatment and/or other services received as part of usual care while living in a recovery residence. This arm serves as the active comparator group for the study.

Arm 2: Peer Recovery Support Services (PRSS) Intervention: The experimental group for this study that involves the implementation of the PRSS intervention. This study will test the preliminary efficacy of the PRSS intervention on Medications for Opioid Use Disorder (MOUD) retention by evenly randomizing N=50 individuals on MOUD living in recovery residences (RRs) to either a 24-week course of the experimental PRSS intervention layered on top of treatment as usual services (TAU+PRSS) vs. an active comparator composed of treatment as usual services without the PRSS intervention (i.e., TAU-alone). Follow ups will be conducted at weeks 2, 4, 8, 12, 16, 20, 24 (end of intervention), 36, and 52 to collect data on the primary outcome of MOUD retention and other outcomes.

Outcomes

Primary Outcome Measures

cumulative MOUD retention
Primary Outcome: Cumulative MOUD retention on all follow-up assessments for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.

Secondary Outcome Measures

Secondary Outcome 1- continuous MOUD retention ("yes" or "no")
Continuous MOUD retention on all follow-up assessments will be tracked for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.
Secondary Outcome 2- opioid relapse ("yes" or "no")
Opioid relapse are measured by tracking responses on the following data sources: Time Line Follow Back.
Secondary Outcome 3- re-initiation of MOUD after dropout ("yes" or "no")
Re-initiation of MOUD after dropout will be measured by examining all follow-up assessments after dropout for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.

Full Information

First Posted
November 7, 2022
Last Updated
September 21, 2023
Sponsor
Potomac Health Foundations
Collaborators
National Institute of Drug Abuse, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05616949
Brief Title
Peer Recovery Support Services for Individuals in Recovery Residences on MOUD
Official Title
Peer Recovery Support Services for Individuals in Recovery Residences on MOUD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
September 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Potomac Health Foundations
Collaborators
National Institute of Drug Abuse, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The United States is experiencing an unprecedented opioid epidemic with a rapid increase in overdose deaths. Medications for opioid use disorder (MOUD) including methadone, buprenorphine, and extended-release naltrexone are efficacious and the recommended standard of care, yet barriers to sustained MOUD treatment reduce the overall efficacy of MOUD. Rates of MOUD retention are alarmingly low and MOUD dropout predicts opioid use/relapse, overdose, and death. While previous research has identified predictors of MOUD retention and adherence, there are no evidence-based interventions to improve MOUD retention. Recovery support services are a broad set of strategies to promote healthy outcomes among individuals with substance use disorder (SUD) that are typically separate from standard professional treatment. Among those strategies most utilized are peer recovery support services (PRSS) and recovery residences (RRs). PRSS include coaching, mentoring, education, and other supports delivered by individuals uniquely qualified by their lived experience with SUD. PRSS are increasingly utilized in a range of clinical settings, and advantages of PRSS include inherent shared understanding of addiction and a high degree of acceptance and understanding that is not found in most professional relationships. Existing research tentatively supports PRSS; however, the evidence to date is sparse and comes with significant methodological limitations and inconsistencies that make it difficult to conclude the efficacy of PRSS. No studies have examined the role of PRSS in promoting retention in MOUD. RRs provide a supportive living environment for persons in recovery from SUD and are widely utilized in the United States with an estimated 17,943 residences in 2020. Despite their proliferation, the evidence for RRs is only moderate and diminished by methodological weaknesses. Further, individuals on MOUD seeking housing through RRs often face increased MOUD-related stigma or may be disqualified from a RR for taking MOUD and need additional support to navigate these challenges. The potential synergistic benefits of combining PRSS and RRs to improve MOUD retention are considerable. PRSS and RRs are already mainstays in the recovery support services repertoire and could be leveraged to support MOUD retention. For example, more frequent, informal outreach typical of PRSS could facilitate regular monitoring of shifting attitudes and behaviors related to MOUD. The structure and accountability embedded in RRs could be used to support MOUD adherence and retention. Waxing and waning motivation to participate in MOUD treatment is common, and standard treatment is often unsuccessful at identifying early signs of future dropout or facilitating re-engagement after dropout. We will recruit participants on MOUD in RRs and provide them with PRSS using approaches such as recovery coaching and care navigation with a particular focus on supporting retention in MOUD care. PRSS will also provide assertive outreach between episodes of care, emphasize continuation in treatment and other recovery activities after leaving a RR (either successfully or unsuccessfully), and emphasize return to care after treatment dropout and/or relapse. The peers will be deeply embedded within the local provider community and care continuum to facilitate ease of care navigation. The ultimate goal of our research agenda is to test the efficacy of a PRSS intervention among individuals with OUD living in RRs through a rigorous trial. The eventual trial design would be informed by preparatory activities and experience proposed in this planning project. Preparatory activities proposed in this project include three major phases. Phase 1 - preparation for the intervention including: building a network of RRs that will be recruitment sites in the pilot RCT, recruiting and training peer support specialists, conducting focus groups and interviews to gather stakeholder input, and developing PRSS approaches to promote MOUD retention. Phase 2 - pilot test the PRSS intervention by randomizing N=50 individuals on MOUD recruited from collaborating RRs to either: a 24-week course of the PRSS intervention added to usual services, or usual services without the PRSS intervention. Phase 3 - gather additional input from former participants and RR staff post-intervention to further refine the intervention, and use lessons learned to inform our trial design and data collection procedures for the next-step R01 application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Substance Use Disorder
Keywords
Medications for Opioid Use Disorder, Opioid Use Disorder, Recovery Residence, Peer Support, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel group randomized design is used. Participants will be randomized to receive treatment as usual (TAU) or the Peer Recovery Support Services (PRSS) intervention with a focus on MOUD retention. Individuals in the PRSS intervention group will receive all components of TAU plus additional peer-delivered recovery support services to aimed at enhancing retention in MOUD treatment. The plan is to recruit 50 total individuals. If there is significant drop out. Randomization will occur in a 1:1 ratio by flipping a coin, and will be conducted using stratified block randomization using random block sizes. Gender is the only stratification variable. Study staff involved with recruitment will be blinded to the participant's condition until after randomization. After randomization, the participant and study staff will all know if the participant was randomized to TAU or to PRSS. The intervention period is 24-weeks with follow ups at weeks 36 and 52.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Title: Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Arm 1: Treatment as Usual (TAU): The treatment and/or other services received as part of usual care while living in a recovery residence. This arm serves as the active comparator group for the study.
Arm Title
Arm 2 Title: Peer Recovery Support Services (PRSS) + TAU
Arm Type
Experimental
Arm Description
Arm 2: Peer Recovery Support Services (PRSS) Intervention: The experimental group for this study that involves the implementation of the PRSS intervention. This study will test the preliminary efficacy of the PRSS intervention on Medications for Opioid Use Disorder (MOUD) retention by evenly randomizing N=50 individuals on MOUD living in recovery residences (RRs) to either a 24-week course of the experimental PRSS intervention layered on top of treatment as usual services (TAU+PRSS) vs. an active comparator composed of treatment as usual services without the PRSS intervention (i.e., TAU-alone). Follow ups will be conducted at weeks 2, 4, 8, 12, 16, 20, 24 (end of intervention), 36, and 52 to collect data on the primary outcome of MOUD retention and other outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU) (Arm 1)
Intervention Description
Treatment as Usual (TAU): The treatment and/or other services received as part of usual care while living in a recovery residence. This arm serves as the active comparator group for the study.
Intervention Type
Behavioral
Intervention Name(s)
Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2)
Intervention Description
Peer Recovery Support Services (PRSS) Intervention: The experimental group for this study that involves the implementation of the PRSS intervention. This study will test the preliminary efficacy of the PRSS intervention on Medications for Opioid Use Disorder (MOUD) retention by evenly randomizing N=50 individuals on MOUD living in recovery residences (RRs) to either a 24-week course of the experimental PRSS intervention layered on top of treatment as usual services
Primary Outcome Measure Information:
Title
cumulative MOUD retention
Description
Primary Outcome: Cumulative MOUD retention on all follow-up assessments for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.
Time Frame
Cumulative MOUD Retention is the proportion of days on MOUD at 24-weeks (end of intervention period).
Secondary Outcome Measure Information:
Title
Secondary Outcome 1- continuous MOUD retention ("yes" or "no")
Description
Continuous MOUD retention on all follow-up assessments will be tracked for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.
Time Frame
Participants who are continuously retained have no gaps in MOUD exceeding 14-days.
Title
Secondary Outcome 2- opioid relapse ("yes" or "no")
Description
Opioid relapse are measured by tracking responses on the following data sources: Time Line Follow Back.
Time Frame
Relapse is defined as ten days of use within a 4-week period.
Title
Secondary Outcome 3- re-initiation of MOUD after dropout ("yes" or "no")
Description
Re-initiation of MOUD after dropout will be measured by examining all follow-up assessments after dropout for the following data sources: 1) Time Line Follow Back; 2) the Maryland PDMP; and 3) Patient Health Records.
Time Frame
Re-initiation of MOUD is defined as re-initiation onto any MOUD for at least 7 days after MOUD dropout (defined as >14 days without MOUD).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18+ (inclusive); meets diagnostic criteria for OUD; residing at a RR affiliated with this study; seeking treatment with and successfully inducted onto MOUD (i.e., XR-NTX, SL-BUP, XR-BUP, or methadone); English speaking; willing and able to provide informed consent. Exclusion Criteria: Currently receiving formalized PRSS outside of the study (not applicable to peer support typical of sponsorship in 12-step mutual support programs or informal support through RRs).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin R. Wenzel, Ph.D.
Phone
410-233-1400
Email
kwenzel@marylandtreatment.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marc J. Fishman, M.D.
Phone
410-233-1400
Email
Mfishman@marylandtreatment.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin R. Wenzel, Ph.D.
Organizational Affiliation
Mountain Manor Treatment Center - Maryland Treatment Centers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc J. Fishman, M.D.
Organizational Affiliation
Mountain Manor Treatment Center - Maryland Treatment Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Treatment Centers
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Wenzel, PhD
Phone
410-233-1400
Email
kwenzel@marylandtreatment.org
Facility Name
Maryland Treatment Centers/Avery Road Treatment Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20853
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Wenzel, PhD
Phone
410-233-1400
Email
kwenzel@marylandtreatment.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Peer Recovery Support Services for Individuals in Recovery Residences on MOUD

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