Opioid Treatment and Peer Recovery Support

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Brown University
Study ID
NCT04978168
Status
Recruiting
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Conditions

  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
May 2025
Primary completion
Dec 30, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Implementation Core
    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.
  • Experimental: Randomized Trial of Peer Support Specialist Model
    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.
  • Active Comparator: Randomized to Treatment as Usual
    After Core Implementation is complete, half of adult participants in probation who consent will be randomly assigned to continue with usual care.

Primary Outcome Measure

Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD [ Time Frame: 26 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27708
Lauren Brinkley-Rubinstein, PhD
[email protected]
919-962-1136
Alice Cates
[email protected]
Temple UniversityPhiladelphiaPennsylvania19122
Steven Belenko, PhD
[email protected]
215-204-2211
Doris Weiland
[email protected]
Brown UniversityProvidenceRhode Island02912
Rosemarie A Martin, PhD
[email protected]
401-863-6656
Jennifer Duff
[email protected]
4018636667

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