Opioid Use DisorderNCT05616949
Peer Recovery Support Services for Individuals in Recovery Residences on MOUD
A study testing Treatment as Usual (TAU) (Arm 1) and Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2) in people with Opioid Use Disorder and Substance Use Disorder, run by Potomac Health Foundations at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Substance Use Disorder
- What is being tested?
- Treatment as Usual (TAU) (Arm 1) and Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2023to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Maryland Treatment Centers
Baltimore, Maryland, 21229
Maryland Treatment Centers/Avery Road Treatment Center
Rockville, Maryland, 20853
About this study
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.
Read more
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.
- Conditions
- Opioid Use Disorder, Substance Use Disorder
- Being tested
- Treatment as Usual (TAU) (Arm 1), Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2)
- Keywords
- Medications for Opioid Use Disorder, Opioid Use Disorder, Recovery Residence, Peer Support, Intervention
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as Usual (TAU) (Arm 1)Behavioural
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.
Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Title: Treatment as Usual (TAU) | Active comparator | 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. Receives: Behavioral: Treatment as Usual (TAU) (Arm 1) |
| Arm 2 Title: Peer Recovery Support Services (PRSS) + TAU | Experimental | 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. Receives: Behavioral: Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cumulative MOUD Retention is the proportion of days on MOUD at 24-weeks (end of intervention period).
Secondary outcomes (3)
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.
Measured: Participants who are continuously retained have no gaps in MOUD exceeding 14-days.
Secondary Outcome 2- opioid relapse ("yes" or "no")
Opioid relapse are measured by tracking responses on the following data sources: Time Line Follow Back.
Measured: Relapse is defined as ten days of use within a 4-week period.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start14 Jul 2023
- Primary completion1 Apr 2025
- Study completion29 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Potomac Health Foundations
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Drug Abuse, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Kevin R. Wenzel, Ph.D., Principal investigator, Mountain Manor Treatment Center - Maryland Treatment CentersMarc J. Fishman, M.D., Principal investigator, Mountain Manor Treatment Center - Maryland Treatment Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616949
- Sponsor's protocol ID
- 1R34DA057627-01
- Status last verified
- Apr 2025
- First submitted
- 7 Nov 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Recovery Support Services for Individuals in Recovery Residences on MOUD
- ClinicalTrials.gov ID
- NCT05616949
- Acronym / sponsor ID
- 1R34DA057627-01
- Conditions
- Opioid Use Disorder, Substance Use Disorder
- Keywords
- Medications for Opioid Use Disorder, Opioid Use Disorder, Recovery Residence, Peer Support, Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Potomac Health FoundationsUniversity, hospital or other
- Collaborators
- National Institute of Drug Abuse, National Institutes of Health (NIH)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 29 Sep 2025 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Title: Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU) (Arm 1)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 Title: Peer Recovery Support Services (PRSS) + TAU | Experimental | Behavioral: Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as Usual (TAU) (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. | Behavioural | Arm 1 Title: Treatment as Usual (TAU) |
| Peer Recovery Support Services (PRSS) + TAU (experimental- 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 | Behavioural | Arm 2 Title: Peer Recovery Support Services (PRSS) + TAU |
Primary outcome
cumulative MOUD retention
Time frame: Cumulative MOUD Retention is the proportion of days on MOUD at 24-weeks (end of intervention period).
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.
3 secondary outcomes
Secondary Outcome 1- continuous MOUD retention ("yes" or "no")
Time frame: Participants who are continuously retained have no gaps in MOUD exceeding 14-days.
Secondary Outcome 2- opioid relapse ("yes" or "no")
Time frame: Relapse is defined as ten days of use within a 4-week period.
Secondary Outcome 3- re-initiation of MOUD after dropout ("yes" or "no")
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin R. Wenzel, Ph.D. principal investigator
Mountain Manor Treatment Center - Maryland Treatment Centers
Marc J. Fishman, M.D. principal investigator
Mountain Manor Treatment Center - Maryland Treatment Centers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as Usual (TAU) (Arm 1) and Peer Recovery Support Services (PRSS) + TAU (experimental- Arm 2) in people with Opioid Use Disorder and Substance Use Disorder, run by Potomac Health Foundations at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative MOUD retention (time frame: Cumulative MOUD Retention is the proportion of days on MOUD at 24-weeks (end of intervention period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.