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Opioid-use DisorderJCOINNCT04978168

Opioid Treatment and Peer Recovery Support

A study testing Core Intervention, Peer Support Specialists (PSS) and Treatment as Usual (TAU) in people with Opioid-use Disorder, run by Brown University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Determine whether a facilitated local change team intervention improves a probation organization's client-level medication for opioid use disorder (MOUD) outcomes and implementation outcomes relative to baseline across multiple sites. 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?
Core Intervention, Peer Support Specialists (PSS) and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
3 sitesUnited States
Study dates
2 Mar 2021to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • Community Provider Staff: Any front-line treatment provider at an agency participating in this study who: (a) provides support to MOUD clients, (b) has an active caseload including some individuals on probation, and (c) willing to commit to 12 months to the project.
  • Probation/Parole Staff: Any probation officer (PO) at an agency participating in this study who (a) has an active caseload, and (b) is willing to commit to 12 months to the project.
  • Individuals on Probation: (a) 18 years or older, (b) committed to probation within 90 days prior to study enrollment, (c) English speaking, (d) diagnosed with OUD, (e) have stable method of contact in community

Who cannot join

  • Individuals on Probation: Currently incarcerated or in a court-mandated inpatient treatment.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Duke University

    Durham, North Carolina, 27708

  • Temple University

    Philadelphia, Pennsylvania, 19122

  • Brown University

    Providence, Rhode Island, 02912

Other trials in United States

About this study

Official title: Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision

Determine whether a facilitated local change team intervention improves a probation organization's client-level medication for opioid use disorder (MOUD) outcomes and implementation outcomes relative to baseline across multiple sites. Determine whether client-level outcomes are further enhanced by the introduction of Peer Support Services.

Read the detailed description

Background: The purpose is to determine whether a facilitated local change team (LCT) intervention improves linkage to medication for opioid use disorder (MOUD) and implementation outcomes, and whether participant-level outcomes are further enhanced by the use of Peer Support Specialists (PSS).

Methods/Design: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trail of PSS (effectiveness study). The study is conducted at 7 performance sites in 3 states.

Phase 1 (Core Implementation Study): The Exploration, Preparation, Implementation, Sustainability (EPIS) framework is used to guide system-change through facilitated LCTs consisting of probation and community treatment staff who are given a core set of implementation strategies which are used to conduct a needs assessment and set goals. The overall objective is to improve linkage to the continuum of evidence-based care for justice-involved individuals with opioid use disorder (OUD). Organizational (program-level) and staff survey are collected at the end of each EPIS stage (baseline Exploration, end of Preparation, end of Implementation, and 12 months [Sustainability]). Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary).

Phase 2 (Effectiveness Study of PSS): After completing implementation, 450 adults on probation are randomized to receive PSS vs. treatment as usual (TAU), with assessments at baseline, 3, and 6 months. This trial tests whether having a trained peer improves clinical outcomes beyond effects of Core Implementation. Implementation program-level outcomes include organizational engagement in MOUD use (primary outcome); changes in staff knowledge and attitudes about MOUD, commitment and efficacy, readiness for change; organizational attitudes for change, commitment and efficacy (secondary outcomes). Client-level effectiveness outcomes include participant engagement in MOUD (primary outcome), probation revocation, illicit opioid use, and overdoses (secondary outcomes). Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS.

Primary Research Questions:

The primary aim is to test the effectiveness of PSS compared to TAU (agency approach after implementation) on outcomes of individuals on probation: Engagement in MOUD (primary effectiveness outcome), probation revocation (secondary), illicit opioid use (secondary), and overdose (tertiary).

The second aim is to test the effectiveness of EPIS-based Core Implementation Intervention relative to baseline on engagement in MOUD (primary implementation outcome).

The third aim is to test the effects of the EPIS implementation strategies relative to baseline on program-level (organizational and staff-level) outcomes.

The fourth aim is to conduct a cost-benefit analysis of implementing PSS compared to TAU.

The fifth aim is to identify organizational and staff barriers and facilitators to intervention implementation by conducting qualitative interviews with key probation and community treatment stakeholders who are managing and delivering the MOUD program.

Being tested
Core Intervention, Peer Support Specialists (PSS), Treatment as Usual (TAU)
Keywords
Opioid Use, Medications for Opioid Use
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Core InterventionBehavioural

    Staff are provided with a core set of implementation strategies to facilitate interorganizational linkages between probation agencies and local community treatment providers.

  • Peer Support Specialists (PSS)Behavioural

    Participants randomized to PSS will meet with a PSS for 6 months. Contact scheduled is flexible and based on the participant's needs and wants, plus written guidance for PSS-participant interactions.

  • Treatment as Usual (TAU)Behavioural

    Participants randomized to TAU will receive the services that will be offered at the time the Core Implementation intervention is completed.

Study groups in NCT04978168
Study groupRoleWhat they receive
Implementation CoreExperimentalDuring baseline Exploration, staff organizational surveys are collected. During Preparation, staff focus groups conduct needs assessment with system mapping of linkage points for screening, assessment, and referral, and the agencies/staff involved in these activities. During Implementation, sites use facilitated local change teams (LCT) provided with a core set implementation strategies to facilitate linkages between probation agencies and local community treatment providers. The LCTs identify barriers to change, approaches to overcome barriers, do goal selection using SMART (specific, measurable, achievable, relevant, timely) goals and evidence for medications, address stigma, and clarify needs/expectations/roles of probation officers and treatment providers, then choose and implement goals and strategies. Sustainability Phase: Facilitators work with LCTs for 12 months using a written action plan based on goal selection.
Receives: Behavioral: Core Intervention
Randomized Trial of Peer Support Specialist ModelExperimentalAfter Core implementation is complete, half of adult participants in probation who consent will be randomly assigned to a Peer Support Specialist (PSS) condition. PSS are assigned to adults diagnosed with OUD within 6 months of entry into probation, in addition to treatment as usual. PSS establish linkages to community providers (medical, mental health, substance use treatment); educate about recovery support services, transportation assistance, MOUD; provide experiential, non-clinical support to individuals with SUD; share skills, offer support for setting goals and navigating the recovery process); and provide referrals and support for treatment, housing, employment, drug court, and probation.
Receives: Behavioral: Peer Support Specialists (PSS)
Randomized to Treatment as UsualActive comparatorAfter Core Implementation is complete, half of adult participants in probation who consent will be randomly assigned to continue with usual care.
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD

    Calculated from self-report survey of being enrolled in MOUD (yes or no) at each assessment.

    Measured: 26 weeks

  2. Program-Level Implementation Outcome: Engagement in MOUD

    MOUD engagement (primary implementation outcome) is defined as enrollment in MOUD treatment program, or filling a prescription for buprenorphine from a provider (in not on MOUD at time of recruitment), or remaining in MOUD treatment (if already on MOUD when recruited or at previous follow-up), coded dichotomously. Number of clients in probation enrolled in MOUD is tracked via medical and probation records.

    Measured: 26 weeks

Secondary outcomes (8)
  1. Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome)

    Calculated from probation records: Number of days detained during the assessment period

    Measured: 26 weeks

  2. Opioid Use (Individual-Level Experimental (Period 2) Outcome)

    Calculated from self-report surveys and urine screens: any opioid use

    Measured: 26 weeks

  3. Non-Fatal Overdose Events (Individual-Level Experimental (Period 2) Outcome)

    Calculated from treatment agency records: number of reports of medical treatment or death due to overdose events.

    Measured: 26 weeks

  4. Staff MOUD Knowledge and Attitudes (Program-Level Implementation Outcome)

    Extent of staff knowledge about and attitudes towards MOUD, commitment and efficacy, readiness for change, using Medications Opinion Survey.

    Measured: 26 weeks

  5. Organizational Readiness for Change (Program-Level Implementation Outcome)

    Measures of organizational climate, functioning, innovation support, leadership, and staff attributes were adapted from the Evidence-Based Practices Attitudes Scale (Aarons, 2004), Survey of Organizational Functioning (IBR, 2005), and Organizational Readiness for Change (IBR, 2009). Organizational linkages for collaboration and coordination between correctional and treatment agency dyads, using the Inter-Organizational Relationships (IOR) Survey.

    Measured: 26 weeks

  6. Input Costs: PSS time (Program-Level Implementation Outcome)

    PSS logs will be used to record the time PSSs spend with each participant (hours and minutes). Data analyses will convert these to dollar costs per participant using information from the Bureau of Labor Statistics.

    Measured: 26 weeks

  7. Input Costs: Medical Usage (Program-Level Implementation Outcome)

    Participant surveys will be sued to record number of visits to each type of medical provider during the study. Data analyses will convert these to dollar costs using Medicare fee-for-service information.

    Measured: 26 weeks

  8. Outcome Costs (Program-Level Implementation Outcome)

    Participant surveys will be used to record number of days in jail during the follow-up period. Analyses will convert these to dollar costs using government information.

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start2 Mar 2021
  3. Primary completion30 Dec 2025
  4. Study completion30 Apr 2026

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Type 1 hybrid implementation-effectiveness study conducted in two phases. The first recruits as staff/leaders from probation agencies and community treatment agencies. The second phase (which starts after the implementation in the first period is completed) recruits adults on probation and staff of probation agencies. The Core Implementation study (first phase) involves a pre-post design. The effectiveness study (second phase) uses randomized parallel assignment with two arms. The initial Core Implementation study involved four phases: Exploration (baseline), Preparation, Implementation, Sustainability (6- and 12-month follow-ups). The subsequent Effectiveness study starts after the Implementation phase is completed, with its own baseline data and follow-ups up to 6 months.
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04978168
Sponsor's protocol ID
2002002636
Other IDs
U01DA050442-01
Acronym
JCOIN
Status last verified
May 2025
First submitted
25 May 2021
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The coordinating center is charged with creating de-identified versions of agency staff and probation individual level data available at the end of the study.

Questions about this trial

What is this clinical trial studying?

A study testing Core Intervention, Peer Support Specialists (PSS) and Treatment as Usual (TAU) in people with Opioid-use Disorder, run by Brown University at 3 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 3 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: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD (time frame: 26 weeks). The study lists 2 primary outcomes in all. 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 19 Oct 2026.

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