Opioid Use DisorderPRSSNCT06696157
EXPANDED SCOPE for Parent Grant Entitled, "Peer Recovery Support Services for Individuals in Recovery Residences on MOUD"
A study testing PRSS intervention for MOUD initiation in people with Opioid Use Disorder, run by Potomac Health Foundations at 1 site in United States.
Trial summary
The United States is experiencing an unprecedented opioid epidemic. Medications for opioid use disorder (MOUD), such as methadone, buprenorphine, and extended-release naltrexone, are the recommended standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- PRSS intervention for MOUD initiation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 29 Sep 2026
- 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
- Currently seeking inpatient treatment at Maryland Treatment Centers program
- English speaking
- Willing and able to provide informed consent
- Able to obtain MOUD through insurance.
Who cannot join
- Having been prescribed and taken a maintenance dose of sublingual buprenorphine or methadone within 14 days of entering the current inpatient treatment episode
- received a dose of XR-buprenorphine or XR-naltrexone within 45 days of entering the current inpatient treatment episode.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maryland Treatment Centers
Baltimore, Maryland, 21229
Kevin Wenzel, PhD, 410-233-1400
About this study
Official title: Peer Recovery Support Services (PRSS) for Individuals in Recovery Residences on MOUD (NOTE: EXPANDED SCOPE VERSION OF PROTOCOL)
The United States is experiencing an unprecedented opioid epidemic. Medications for opioid use disorder (MOUD), such as methadone, buprenorphine, and extended-release naltrexone, are the recommended standard of care. There are, however, many barriers to MOUD initiation so that only a minority of individuals who could benefit from MOUD treatment ever receive it. Even among individuals presenting to a residential level of specialty SUD care, only about 20% of individuals with OUD initiate MOUD leaving them at a higher risk of opioid relapse, overdose, and death. Thus, the goal of this expansion of scope pilot study is to address this gap by modifying our currently R34-funded intervention (RFA-DA-22-034; Project # 1R34DA057627-01) that leverages the impact of peer recovery support services (PRSS) to promote MOUD initiation. Although PRSS for MOUD initiation shows promise within emergency department settings, the impact of PRSS for MOUD initiation within residential substance use disorder (SUD) settings is unknown. Residential SUD settings are an ideal opportunity to initiate medications because individuals with OUD typically have access to medically-managed withdrawal and the opportunity to learn about and initiate onto MOUD. This PRSS intervention has already been developed in the R34 parent grant to promote MOUD retention, and in this expanded scope project it will be further adapted and tested with a small pilot sample of individuals (N = 10-20) who are further upstream in the cascade of care (COC). Peers will be embedded within the inpatient program unit where the study will take place. Early into their inpatient stay and before MOUD initiation occurs, peers will introduce themselves to patients and provide motivational enhancements for MOUD initiation and inpatient treatment retention through a variety of strategies. Peer strategies will be based on the existing PRSS intervention in the parent grant and may include exploration of MOUD knowledge and attitudes, discussion of relevant lived experience, MOUD psycho-education, and a collaboratively completed wellness plan. Upon discharge, peers will use other strategies to encourage uptake and retention of MOUD such as assertive outreach and emphasize return to care after treatment dropout and/or relapse. The proposed project will explore the feasibility and acceptability of PRSS on MOUD initiation in residential SUD treatment by pilot testing the PRSS intervention with a sample of 10-20 participants receiving an 8-week course of treatment. During the intervention period, the PRSS approach will be adapted and refined with feedback from peer recovery support coaches who have helped develop and test the parent intervention for MOUD retention. Our primary outcomes are: 1) MOUD initiation (yes/no) upon discharge of the inpatient SUD program, and 2) PRSS feasibility and acceptability as measured by a participant satisfaction survey. If this pilot work is successful, the investigators would further test this MOUD initiation-focused version of the PRSS intervention via a future R01-funded Randomized Controlled Trial.
Read the detailed description
The United States is experiencing an opioid epidemic marked by significant overdose deaths. Although medications for opioid use disorder (MOUD) are efficacious, the rates of MOUD initiation and retention are alarmingly low, with 11% of patients with an OUD diagnosis initiating MOUD and only 3.5% being retained on treatment for a minimum of 6 months. Also, national initiation rates onto MOUD within inpatient substance use disorder (SUD) programs are 18%, which again demonstrates low uptake of MOUD. Supplementing mediation-based treatment with Peer Recovery Support Services (PRSS) may be an effective strategy to encourage MOUD utilization, yet no such evidence-based interventions to specifically improve MOUD initiation and retention currently exist. To address this problem, the ongoing R34 parent grant-funded study (RFA-DA-22-034; Project # 1R34DA057627-01) is developing a new intervention that leverages PRSS to increase MOUD retention in patients living in recovery residences (RRs) and 3.1 residential programs. The parent grant study, however, does not address the aforementioned lagging initiation rates within inpatient SUD treatment programs.
To address this gap, the investigative team is conducting this small pilot study to expand the scope of our parent grant clinical trial to improve MOUD initiation across the OUD cascade of care COC. The ongoing parent grant study's goal is to enhance retention for individuals who have already initiated MOUD and are now living in 3.1 residential programs or Recovery Residences (RRs), which are both further downstream in the OUD COC. This small pilot study will expand the scope of the existing parent project by also utilizing PRSS during inpatient SUD treatment, which is more upstream in the COC.
The rationale for this expansion of scope pilot study is that by recruiting participants who are more stable and further downstream in the OUD COC, the current parent project intervention under investigation misses an opportunity to increase MOUD initiation. Preliminary data gathered from our electronic health record at our institution, Maryland Treatment Centers, showed that only 46% of our inpatients diagnosed with OUD initiate MOUD before leaving inpatient SUD treatment, despite the fact that we recommend MOUD as the first-line standard of care. Furthermore, patients with OUD, which included both premature dropouts and successful program completers, left treatment after an average of two weeks (i.e., 14.89 days). Early dropout limits a patient's opportunities to initiate MOUD and/or become stably retained on MOUD. Thus, investigators will expand the scope of the R34 project to include adapting the existing PRSS intervention for MOUD initiation and obtain pilot data on feasibility in (N = 35) patients enrolled in SUD inpatient treatment. We will accomplish this goal by piloting the PRSS intervention for MOUD initiation during the time that remains for the existing R34 award. All participants will receive the PRSS intervention for a total of 8 weeks.
On important goal of this expanded scope pilot is to explore the feasibility of using PRSS with SUD inpatients. Parent grant Phase 1 qualitative interviews were conducted with stakeholders (N = 16) that included peers (50% of total sample), patients on MOUD (25% of sample), and other professionals working with patients on MOUD (25% of sample) to assess these stakeholders' opinions of the parent grant version of PRSS. Overall, stakeholders found PRSS to be useful and consistent with the tools peers use to help patients adhere to MOUD. The parent grant's rate of recruitment and randomization meets our expected study target goals per month, and demonstrates that the PRSS intervention is feasible with respect to our ability to recruit effectively at Mountain Manor Treatment Center (MMTC), which is under the umbrella of Maryland Treatment Centers and is the study location for this expansion of scope pilot study. Unlike the parent grant that only enrolls patients who are already inducted onto MOUD, this expansion of scope proposal will only recruit people who are in SUD inpatient care and who are not currently on MOUD in an effort to get them to initiate MOUD. In summary, the expanded scope aim is as follows.
Specific Aim: Investigators will pilot an adapted version of the PRSS parent grant intervention that focuses on improving MOUD initiation in a small uncontrolled pilot sample (N = 35) of participants who are being treated further upstream in the OUD COC within an inpatient SUD treatment setting. Hypothesis: Investigators hypothesize that peers and participants will find the modified PRSS intervention to be both acceptable and feasible and that MOUD initiation rates will compare favorably to historical data from our electronic health records.
Impact: The research in this expansion of scope pilot study will contribute to NIDA's overarching mission to ameliorate the ongoing opioid epidemic which continues to be a serious problem in the United States. If successful, this pilot work would be an initial step toward developing an intervention that would help opioid users to initiate MOUD, which is the underutilized standard of care for OUD treatment. This research has great potential to directly reduce the impact of the current opioid epidemic, which is a major public health crisis that continues to plague the USA.
- Conditions
- Opioid Use Disorder
- Being tested
- PRSS intervention for MOUD initiation
- Keywords
- Peer Support Specialist, Opioid Use Disorder, Peer Recovery Support Services, Medications for Opioid Use Disorder, MOUD, Substance Use Disorder
- 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.
PRSS intervention for MOUD initiationBehavioural
All participants of this expanded scope pilot study will be in a single-arm of an uncontrolled trial of PRSS intervention for MOUD initiation for a total of 8 weeks, starting in inpatient substance abuse treatment. This is distinguished from the R34 parent grant which targets MOUD retention and adherence rather than MOUD initiation.
| Study group | Role | What they receive |
|---|---|---|
| single-arm of an uncontrolled trial of the PRSS intervention for MOUD initiation | Experimental | Not described Receives: Behavioral: PRSS intervention for MOUD initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOUD initiation at inpatient substance abuse treatment discharge
MOUD initiation status at inpatient substance abuse treatment discharge. Did the participant initiate by the date of discharge? (Yes / No)
Measured: 8 weeks
Secondary outcomes (3)
MOUD Initiation after inpatient substance use disorder treatment discharge
MOUD initiation status at inpatient substance abuse treatment discharge. Did the participant initiate MOUD at any time during the 8 weeks course of the intervention? (Yes / No)
Measured: 8 weeks
MOUD Retention
Among MOUD initiators during inpatient substance abuse treatment, was the participant retained on MOUD at the end of 8 week intervention period? (Yes / No)
Measured: 8 weeks
Length of inpatient substance abuse treatment stay
Number of days retained in inpatient substance abuse treatment care
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Dec 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion29 Sep 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Potomac Health Foundations
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696157
- Sponsor's protocol ID
- 1R34DA057627-01-EXPANDED-SCOPE
- Other IDs
- 1R34DA057627-01
- Acronym
- PRSS
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2024
- Last updated
- 4 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Recovery Support Services (PRSS) for Individuals in Recovery Residences on MOUD (NOTE: EXPANDED SCOPE VERSION OF PROTOCOL)
- ClinicalTrials.gov ID
- NCT06696157
- Acronym / sponsor ID
- PRSS / 1R34DA057627-01-EXPANDED-SCOPE
- Conditions
- Opioid Use Disorder
- Keywords
- Peer Support Specialist, Opioid Use Disorder, Peer Recovery Support Services, Medications for Opioid Use Disorder, MOUD, Substance Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Potomac Health FoundationsUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 20 Nov 2024 (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. Medications for opioid use disorder (MOUD), such as methadone, buprenorphine, and extended-release naltrexone, are the recommended standard of care. There are, however, many barriers to MOUD initiation so that only a minority of individuals who could benefit from MOUD treatment ever receive it. Even among individuals presenting to a residential level of specialty SUD care, only about 20% of individuals with OUD initiate MOUD leaving them at a higher risk of opioid relapse, overdose, and death. Thus, the goal of this expansion of scope pilot study is to address this gap by modifying our currently R34-funded intervention (RFA-DA-22-034; Project # 1R34DA057627-01) that leverages the impact of peer recovery support services (PRSS) to promote MOUD initiation. Although PRSS for MOUD initiation shows promise within emergency department settings, the impact of PRSS for MOUD initiation within residential substance use disorder (SUD) settings is unknown. Residential SUD settings are an ideal opportunity to initiate medications because individuals with OUD typically have access to medically-managed withdrawal and the opportunity to learn about and initiate onto MOUD. This PRSS intervention has already been developed in the R34 parent grant to promote MOUD retention, and in this expanded scope project it will be further adapted and tested with a small pilot sample of individuals (N = 10-20) who are further upstream in the cascade of care (COC). Peers will be embedded within the inpatient program unit where the study will take place. Early into their inpatient stay and before MOUD initiation occurs, peers will introduce themselves to patients and provide motivational enhancements for MOUD initiation and inpatient treatment retention through a variety of strategies. Peer strategies will be based on the existing PRSS intervention in the parent grant and may include exploration of MOUD knowledge and attitudes, discussion of relevant lived experience, MOUD psycho-education, and a collaboratively completed wellness plan. Upon discharge, peers will use other strategies to encourage uptake and retention of MOUD such as assertive outreach and emphasize return to care after treatment dropout and/or relapse. The proposed project will explore the feasibility and acceptability of PRSS on MOUD initiation in residential SUD treatment by pilot testing the PRSS intervention with a sample of 10-20 participants receiving an 8-week course of treatment. During the intervention period, the PRSS approach will be adapted and refined with feedback from peer recovery support coaches who have helped develop and test the parent intervention for MOUD retention. Our primary outcomes are: 1) MOUD initiation (yes/no) upon discharge of the inpatient SUD program, and 2) PRSS feasibility and acceptability as measured by a participant satisfaction survey. If this pilot work is successful, the investigators would further test this MOUD initiation-focused version of the PRSS intervention via a future R01-funded Randomized Controlled Trial.
Detailed description
The United States is experiencing an opioid epidemic marked by significant overdose deaths. Although medications for opioid use disorder (MOUD) are efficacious, the rates of MOUD initiation and retention are alarmingly low, with 11% of patients with an OUD diagnosis initiating MOUD and only 3.5% being retained on treatment for a minimum of 6 months. Also, national initiation rates onto MOUD within inpatient substance use disorder (SUD) programs are 18%, which again demonstrates low uptake of MOUD. Supplementing mediation-based treatment with Peer Recovery Support Services (PRSS) may be an effective strategy to encourage MOUD utilization, yet no such evidence-based interventions to specifically improve MOUD initiation and retention currently exist. To address this problem, the ongoing R34 parent grant-funded study (RFA-DA-22-034; Project # 1R34DA057627-01) is developing a new intervention that leverages PRSS to increase MOUD retention in patients living in recovery residences (RRs) and 3.1 residential programs. The parent grant study, however, does not address the aforementioned lagging initiation rates within inpatient SUD treatment programs.
To address this gap, the investigative team is conducting this small pilot study to expand the scope of our parent grant clinical trial to improve MOUD initiation across the OUD cascade of care COC. The ongoing parent grant study's goal is to enhance retention for individuals who have already initiated MOUD and are now living in 3.1 residential programs or Recovery Residences (RRs), which are both further downstream in the OUD COC. This small pilot study will expand the scope of the existing parent project by also utilizing PRSS during inpatient SUD treatment, which is more upstream in the COC.
The rationale for this expansion of scope pilot study is that by recruiting participants who are more stable and further downstream in the OUD COC, the current parent project intervention under investigation misses an opportunity to increase MOUD initiation. Preliminary data gathered from our electronic health record at our institution, Maryland Treatment Centers, showed that only 46% of our inpatients diagnosed with OUD initiate MOUD before leaving inpatient SUD treatment, despite the fact that we recommend MOUD as the first-line standard of care. Furthermore, patients with OUD, which included both premature dropouts and successful program completers, left treatment after an average of two weeks (i.e., 14.89 days). Early dropout limits a patient's opportunities to initiate MOUD and/or become stably retained on MOUD. Thus, investigators will expand the scope of the R34 project to include adapting the existing PRSS intervention for MOUD initiation and obtain pilot data on feasibility in (N = 35) patients enrolled in SUD inpatient treatment. We will accomplish this goal by piloting the PRSS intervention for MOUD initiation during the time that remains for the existing R34 award. All participants will receive the PRSS intervention for a total of 8 weeks.
On important goal of this expanded scope pilot is to explore the feasibility of using PRSS with SUD inpatients. Parent grant Phase 1 qualitative interviews were conducted with stakeholders (N = 16) that included peers (50% of total sample), patients on MOUD (25% of sample), and other professionals working with patients on MOUD (25% of sample) to assess these stakeholders' opinions of the parent grant version of PRSS. Overall, stakeholders found PRSS to be useful and consistent with the tools peers use to help patients adhere to MOUD. The parent grant's rate of recruitment and randomization meets our expected study target goals per month, and demonstrates that the PRSS intervention is feasible with respect to our ability to recruit effectively at Mountain Manor Treatment Center (MMTC), which is under the umbrella of Maryland Treatment Centers and is the study location for this expansion of scope pilot study. Unlike the parent grant that only enrolls patients who are already inducted onto MOUD, this expansion of scope proposal will only recruit people who are in SUD inpatient care and who are not currently on MOUD in an effort to get them to initiate MOUD. In summary, the expanded scope aim is as follows.
Specific Aim: Investigators will pilot an adapted version of the PRSS parent grant intervention that focuses on improving MOUD initiation in a small uncontrolled pilot sample (N = 35) of participants who are being treated further upstream in the OUD COC within an inpatient SUD treatment setting. Hypothesis: Investigators hypothesize that peers and participants will find the modified PRSS intervention to be both acceptable and feasible and that MOUD initiation rates will compare favorably to historical data from our electronic health records.
Impact: The research in this expansion of scope pilot study will contribute to NIDA's overarching mission to ameliorate the ongoing opioid epidemic which continues to be a serious problem in the United States. If successful, this pilot work would be an initial step toward developing an intervention that would help opioid users to initiate MOUD, which is the underutilized standard of care for OUD treatment. This research has great potential to directly reduce the impact of the current opioid epidemic, which is a major public health crisis that continues to plague the USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm of an uncontrolled trial of the PRSS intervention for MOUD initiation | Experimental | Behavioral: PRSS intervention for MOUD initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18+ (inclusive)
- Meets diagnostic criteria for OUD
- Currently seeking inpatient treatment at Maryland Treatment Centers program
- English speaking
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Having been prescribed and taken a maintenance dose of sublingual buprenorphine or methadone within 14 days of entering the current inpatient treatment episode
- received a dose of XR-buprenorphine or XR-naltrexone within 45 days of entering the current inpatient treatment episode.
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 |
|---|---|---|
| PRSS intervention for MOUD initiationAll participants of this expanded scope pilot study will be in a single-arm of an uncontrolled trial of PRSS intervention for MOUD initiation for a total of 8 weeks, starting in inpatient substance abuse treatment. This is distinguished from the R34 parent grant which targets MOUD retention and adherence rather than MOUD initiation. | Behavioural | single-arm of an uncontrolled trial of the PRSS intervention for MOUD initiation |
Primary outcome
MOUD initiation at inpatient substance abuse treatment discharge
Time frame: 8 weeks
MOUD initiation status at inpatient substance abuse treatment discharge. Did the participant initiate by the date of discharge? (Yes / No)
3 secondary outcomes
MOUD Initiation after inpatient substance use disorder treatment discharge
Time frame: 8 weeks
MOUD Retention
Time frame: 8 weeks
Length of inpatient substance abuse treatment stay
Time frame: 8 weeks
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 4 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRSS intervention for MOUD initiation in people with Opioid Use Disorder, run by Potomac Health Foundations at 1 site 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 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 1 site 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?
Contact Kevin R Wenzel, PhD (4102331400, KWenzel@marylandtreatment.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOUD initiation at inpatient substance abuse treatment discharge (time frame: 8 weeks). 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 4 Apr 2025.