Opioid Treatment and Peer Recovery Support

NCT04978168 | Recruiting

• 2 other identifiers: 2002002636U01DA050442-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 3

Brief 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. Determine whether client-level outcomes are further enhanced by the introduction of Peer Support Services.

Conditions

Opioid-use Disorder

Keywords

Opioid Use; Medications for Opioid Use

Outcome Measures

Primary Outcomes (2)

• 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.

  26 weeks

• 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.

  26 weeks

Secondary Outcomes (8)

• Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome)

  26 weeks

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

  26 weeks

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

  26 weeks

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

  26 weeks

• Organizational Readiness for Change (Program-Level Implementation Outcome)

  26 weeks

Study Arms (3)

Implementation Core

EXPERIMENTAL

During 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.

Behavioral: Core Intervention

Randomized Trial of Peer Support Specialist Model

EXPERIMENTAL

After 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.

Behavioral: Peer Support Specialists (PSS)

Randomized to Treatment as Usual

ACTIVE COMPARATOR

After Core Implementation is complete, half of adult participants in probation who consent will be randomly assigned to continue with usual care.

Behavioral: Treatment as Usual (TAU)

Interventions

Core Intervention BEHAVIORAL

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

Implementation Core

Peer Support Specialists (PSS) BEHAVIORAL

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.

Randomized Trial of Peer Support Specialist Model

Treatment as Usual (TAU) BEHAVIORAL

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

Randomized to Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead
• University of North Carolina, Chapel Hill: collaborator
• Temple University: collaborator
• University of Rhode Island: collaborator
• The Miriam Hospital: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• CODAC Behavioral Healthcare: collaborator
• Duke University: collaborator

Study Sites (3)

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rosemarie A Martin, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Damaris J Rohsenow, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Lauren Brinkley-Rubinstein, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Steven Belenko, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

• Lynda Stein, PhD

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

• Josiah Rich, MD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosemarie A Martin, PhD

CONTACT

401-863-6656; Rosemarie_Martin@brown.edu

Jennifer Duff

CONTACT

401-863-6667; Jennifer_Duff@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: July 27, 2021
• Study Start: March 2, 2021
• Primary Completion: December 30, 2025
• Study Completion: April 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available after the results of the primary study analyses have been accepted for publication. The data will be available for five years.
• Access Criteria: De-identified data will be shared with the Methodology and Advanced Analytics Resource Center (MAARC) of JCOIN and with qualified researchers on request to the MAARC.

Locations

US (3)