Opioid Treatment + Peer Recovery Support for Opioid Use Disorder

(JCOIN Trial)

Recruiting at 3 trial locations

Overseen By Jennifer Duff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Must be taking: Opioid use disorder medications

Disqualifiers: Incarcerated, Court-mandated inpatient treatment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment outcomes for individuals with opioid use disorder (OUD) on probation. Researchers are testing whether a team-based approach within probation organizations can enhance the effectiveness of medication treatments and whether adding support from people with lived experience (peer support) can further improve recovery. Participants will be divided into groups, with some receiving standard treatment (such as methadone, buprenorphine, or naltrexone) and others receiving additional peer support. The study seeks adults recently placed on probation who have OUD and a stable method of community contact. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could transform OUD treatment within probation settings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that peer support services for opioid use disorder (OUD) are generally well-received. Studies indicate that peer support workers, who have personal experience with recovery, can improve treatment outcomes by offering support and guidance to others in recovery. These studies have not reported any major safety concerns.

Specific safety information about the main treatment being tested is not yet available, as the trial is in an early stage. At this phase, detailed safety data might not be ready. Early-phase trials primarily focus on assessing the safety of a treatment, so safety is being carefully monitored at this point. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it is exploring a unique combination of opioid treatment and peer recovery support for individuals with opioid use disorder (OUD). Unlike standard treatments that primarily focus on medication-assisted therapy (MAT) like methadone or buprenorphine, this trial is testing a dual approach. The core intervention aims to improve the coordination between probation agencies and community treatment providers, enhancing access and linkage to care. Additionally, the introduction of Peer Support Specialists adds a personalized, experiential layer of support, facilitating connections to resources like housing and employment. This holistic approach not only targets the medical aspect of OUD but also addresses social and behavioral support, which could lead to more sustainable recovery outcomes.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that peer support services can assist people with opioid use disorder (OUD). In this trial, some participants will receive Peer Support Specialist (PSS) services alongside their usual treatment. Studies find that those receiving peer support are more likely to continue treatment and experience fewer relapses. They also tend to achieve better recovery outcomes. The intervention primarily aims to connect probation agencies with treatment providers to enhance results. Although specific data on this exact approach is limited, similar methods have successfully improved access to and continuation of treatment in other areas. These strategies together aim to boost support and recovery for people with OUD in the probation system. ^{1 6 7 8 9}

Who Is on the Research Team?

Damaris J Rohsenow, PhD

Principal Investigator

Brown University

Lauren Brinkley-Rubinstein, PhD

Principal Investigator

Duke University

Josiah Rich, MD

Principal Investigator

The Miriam Hospital

Lynda Stein, PhD

Principal Investigator

University of Rhode Island

Steven Belenko, PhD

Principal Investigator

Temple University

Rosemarie A Martin, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Probation/Parole Staff: Any probation officer (PO) at an agency participating in this study who has an active caseload and is willing to commit to 12 months to the project

I am a front-line treatment provider supporting MOUD clients, including those on probation, and can commit to 12 months.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Implementation Study

The EPIS framework is used to guide system-change through facilitated local change teams (LCTs) to improve linkage to evidence-based care for justice-involved individuals with opioid use disorder.

12 months

Multiple visits for surveys and focus groups

Effectiveness Study of Peer Support Specialist (PSS)

450 adults on probation are randomized to receive PSS vs. treatment as usual, with assessments at baseline, 3, and 6 months.

6 months

3 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of MOUD engagement and other outcomes.

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Core Intervention
• Peer Support Specialists (PSS)
• Treatment as Usual (TAU)

Trial Overview 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.

How Is the Trial Designed?

Group I: Randomized Trial of Peer Support Specialist Model Experimental Treatment 1 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 Core Experimental Treatment 1 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 Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

University of Rhode Island

Collaborator

Trials

57

Recruited

22,400+

Temple University

Collaborator

Trials

321

Recruited

89,100+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

CODAC Behavioral Healthcare

Collaborator

Trials

1

Recruited

450+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A 12-week peer-facilitated physical activity intervention called TREC was found to be acceptable and feasible for 26 low-active patients undergoing methadone maintenance treatment, with participants attending 63% of sessions and 69% using activity trackers.

The intervention led to small-to-moderate increases in physical activity and positive feelings, along with reductions in illicit opioid use, although it did not significantly impact depression or anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of a Peer-Facilitated Physical Activity Intervention in Methadone Maintenance. Abrantes, AM., Van Noppen, D., Bailey, G., et al.[2022]

In a study of 305 methadone-maintained smokers, only 38% met the recommended levels of physical activity, despite recognizing the benefits of exercise, such as relapse prevention.

Encouraging increased physical activity among methadone-maintained individuals could significantly improve their physical and mental health, as well as support their drug treatment efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. Caviness, CM., Bird, JL., Anderson, BJ., et al.[2021]

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

Physical activity interventions for patients undergoing opioid substitution therapy have been shown to improve physical fitness and reduce substance use, based on a systematic review of 10 studies.

Despite the positive findings, the majority of studies in this area lack high methodological quality and sufficient power, indicating a need for more robust clinical trials to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Physical Activity in Opioid Substitution Therapy: A Systematic Review of Interventional and Observational Studies. Alpers, SE., Furulund, E., Pallesen, S., et al.[2022]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

The Peer Activate intervention, delivered by peer recovery specialists, showed high feasibility and acceptability, with 86.5% of participants initiating the program and 81.3% completing at least 75% of sessions, indicating strong engagement among low-income, minoritized populations.

Participants in the Peer Activate program had a significantly higher retention rate in methadone treatment (88.6%) compared to those receiving standard treatment, along with improved adherence to methadone and reduced substance use frequency, highlighting the potential effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. Magidson, JF., Kleinman, MB., Bradley, V., et al.[2023]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

Exercise interventions for individuals with opioid use disorder (OUD) have shown positive effects on immune function, pain reduction, cravings, anxiety, depression, mood, and overall quality of life, based on a review of 13 studies.

While exercise is considered an acceptable and feasible adjunct treatment for OUD, most studies involved small sample sizes, highlighting the need for further research with larger groups to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise interventions for individuals with opioid use disorder: a scoping review. Shreffler, J., Genova, G., Huecker, M.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325329/

Design and Methods of Opt2Move Full Factorial Trial - PMC Opt2Move is a theory-guided moderate and vigorous physical activity (MVPA) promotion trial that uses multiphase optimization strategy (MOST) methodology.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8664978/

Feasibility and acceptability of a digital health intervention ... Meta-analyses highlight the effectiveness of buprenorphine in reducing adverse outcomes, including lowering fatality rates associated with overdose (Mattick, ...

3. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-25-2020/number-3-september-2020/development-of-a-novel-behavioral-intervention-for-opioid-use-disorders/

Development of a Novel Behavioral Intervention for Opioid ... The purpose of this article is to describe the process of developing and organizing the novel behavioral manual-based treatment protocol for use among ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07993-2

Integrated exercise program in opioid agonist therapy clinics ... Results from these studies suggest that exercise interventions could be desirable on physical fitness [19], substance use [16], and quality of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1755296621000442

Exploring the acceptability of exercise as an adjunct ... This study provides insight into the acceptability and receptiveness of residential SUD treatment to exercise programming.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S138650562200106X

A comprehensive mobile health intervention to prevent and ... Between 2019 and 2021, the relative increase in the number of opioid-related drug overdose deaths was more than 50% [3], [4]. Of those persons 12 years and ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07213-3

Smartphone intervention to optimize medication-assisted ... We developed the smartphone app-based intervention OptiMAT as an adjunctive intervention to improve MOUD outcomes.

8. mhealth.jmir.org mhealth.jmir.org/2024/1/e49751

Users' Acceptability and Perceived Efficacy of mHealth for ... This study aims to synthesize qualitative insights into opioid users' acceptability and perceived efficacy of mHealth and wearable technologies for opioid use ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8452230/

A Feasibility Study of a Peer-Facilitated Physical Activity ... Low active, opioid dependent clients showed increases in PA during the 12-week intervention. A future randomized clinical trial is necessary to determine the ...