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Opioid Treatment + Peer Recovery Support for Opioid Use Disorder (JCOIN Trial)
N/A
Recruiting
Led By Damaris J Rohsenow, PhD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
JCOIN Trial Summary
This trial will test whether an intervention to help probation organizations improve their outcomes for clients with opioid use disorder, including introducing peer support services, is effective.
Who is the study for?
This trial is for adults over 18 on probation within the last 90 days, diagnosed with Opioid Use Disorder (OUD), who speak English and have a stable contact method. Probation officers and community provider staff meeting specific criteria related to their role and experience are also eligible.Check my eligibility
What is being tested?
The study aims to improve medication outcomes for opioid use disorder in probation settings by testing a local change team intervention. It will also assess if adding Peer Support Services enhances these client-level outcomes.See study design
What are the potential side effects?
Since this trial focuses on organizational interventions rather than medical treatments, it does not directly involve side effects of medications or procedures.
JCOIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD
Program-Level Implementation Outcome: Engagement in MOUD
Secondary outcome measures
Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome)
Input Costs: Medical Usage (Program-Level Implementation Outcome)
Input Costs: PSS time (Program-Level Implementation Outcome)
+5 moreJCOIN Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Randomized Trial of Peer Support Specialist ModelExperimental Treatment1 Intervention
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.
Group II: Implementation CoreExperimental Treatment1 Intervention
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.
Group III: Randomized to Treatment as UsualActive Control1 Intervention
After Core Implementation is complete, half of adult participants in probation who consent will be randomly assigned to continue with usual care.
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Who is running the clinical trial?
University of Rhode IslandOTHER
52 Previous Clinical Trials
21,741 Total Patients Enrolled
Temple UniversityOTHER
296 Previous Clinical Trials
82,345 Total Patients Enrolled
Brown UniversityLead Sponsor
456 Previous Clinical Trials
562,631 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, recently on probation, speak English, diagnosed with OUD, and have a stable contact method.I am a probation officer with an active caseload, have worked at my agency for over 6 months, and can commit to a 12-month project.I am a front-line treatment provider with at least 3 months of experience and willing to commit for 12 months.I am a front-line treatment provider supporting MOUD clients, including those on probation, and can commit to 12 months.I am over 18, recently put on probation, speak English, diagnosed with OUD, and have a stable contact method.
Research Study Groups:
This trial has the following groups:- Group 1: Implementation Core
- Group 2: Randomized Trial of Peer Support Specialist Model
- Group 3: Randomized to Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrolment for this clinical experiment?
"Affirmative. Clinicaltrials.gov details confirm that this trial, first posted on March 2nd 2021, is currently recruiting patients for participation. The study requires 680 volunteers from 3 distinct sites to complete the necessary research."
Answered by AI
Are there any vacancies available in this trial for participants?
"According to data available on clinicaltrials.gov, this research study is still enrolling patients. It was originally listed in March 2021 and updated recently in February 2022."
Answered by AI
What do the researchers aspire to learn through this clinical trial?
"This clinical trial will span a period of 52 weeks and its primary outcome is the engagement in Medications for Opioid Use Disorder (MOUD). Other prognostic measures include staff knowledge regarding MOUD, commitment to change, probability of probation revocation, and illicit opioid use."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of North Carolina at Chapel Hill
Temple University
What portion of applicants met pre-screening criteria?
Met criteria
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