Community Resource Linkage for Opioid Use Disorder

Overseen By John F Kelly, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Buprenorphine

Disqualifiers: Non-English fluency, Active suicidality, Neurodevelopmental disorders, Active psychosis, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to support individuals with opioid use disorder by connecting them to recovery community centers, known as Recovery Community Center Linkage (RCCL). The goal is to determine if this direct connection is more beneficial than simply providing information about support services. Participants will either meet with a coach who links them to a recovery center or with a coach who provides a list of resources. It suits anyone diagnosed with opioid use disorder in the past year, receiving buprenorphine treatment at Massachusetts General Hospital, and residing in Massachusetts. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in supporting recovery from opioid use disorder.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on buprenorphine treatment, so you should continue that medication.

What prior data suggests that this intervention protocol is safe?

Research shows that connecting people to recovery community centers (RCCs) is generally safe. Studies have found RCCs helpful for those recovering from substance use problems. However, specific safety data for the Community Resource Center Linkage (RCCL) treatment itself is not available.

Similar studies have linked people to recovery support without major safety issues. Since this approach does not involve drugs or surgery, it carries fewer risks. This new method primarily involves meetings with recovery coaches and connecting with community support, which is considered low-risk.

For those considering joining this trial, it's important to know that this type of support aims to help, not harm, and is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Many treatments for opioid use disorder focus on medication-assisted therapies like methadone, buprenorphine, or naltrexone. However, the Recovery Community Center Linkage (RCCL) approach is unique because it emphasizes direct, personalized connections to community resources. Unlike traditional methods, RCCL involves a brief meeting with a recovery coach who not only informs participants about recovery services but also facilitates an active connection to a community center member. This personalized, peer-supported approach aims to enhance engagement and support during recovery, which researchers believe could lead to more sustained recovery outcomes.

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

Research has shown that connecting people with opioid use disorder to recovery community centers (RCCs) can be beneficial. Studies indicate that spending more time in RCCs often leads to improvements in substance use, access to recovery resources, and overall mental and social well-being. Additionally, a survey of directors from opioid treatment programs found that linking patients to these centers improved recovery outcomes. By involving people in supportive communities, they gain access to resources and peer support that help them stay on track with their recovery. In this trial, participants in the Recovery Community Center Linkage (RCCL) arm will be linked to a recovery community center, which could effectively support those undergoing treatment for opioid use disorder. Meanwhile, the Control Condition (CC) arm will provide participants with information about recovery support services without the direct linkage. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with an opioid use disorder diagnosis who are currently in outpatient treatment with buprenorphine, and started this treatment within the last year. It's not suitable for non-English speakers, individuals unable to consent due to neurodevelopmental disorders or neural trauma, or those experiencing active psychosis or suicidality.

Inclusion Criteria

Current residence in Massachusetts

I am receiving outpatient buprenorphine treatment at Massachusetts General Hospital.

Past-year opioid use disorder diagnosis per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition

Exclusion Criteria

Active suicidality

Non-English fluency

Past-year attendance at a recovery community center or recovery support center

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Develop, manualize, and refine RCCL and CC protocols via stakeholder feedback

Up to 48 months

Treatment

Participants receive either RCCL or CC intervention, involving meetings with recovery coaches and linkage to recovery community centers

3 months

Multiple meetings with recovery coaches

Follow-up

Participants are monitored for feasibility, acceptability, and efficacy of interventions

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Control Condition (CC)
• Recovery Community Center Linkage (RCCL)

Trial Overview The study tests a new intervention that helps people receiving medication for opioid addiction connect with recovery community centers. Participants will be randomly assigned to either this new approach or a control condition without such linkage, to compare outcomes.

How Is the Trial Designed?

Group I: Recovery Community Center Linkage (RCCL) Experimental Treatment 1 Intervention

The RCCL arm will involve a brief (\~20 minutes) meeting with a recovery coach (i.e. linkage manager), in which the recovery coach will inform the participant of recovery support services, including recovery community centers, and link them to a recovery community center, with the aid of a facilitated connection to a volunteer recovery community center member (i.e. peer facilitator). The linkage manager will also provide the participant with a list of recovery support service resources.

Group II: Control Condition (CC) Active Control 1 Intervention

The CC arm will involve a time-matched meeting with a recovery coach (i.e. linkage manager), in which the recovery coach will broadly inform the participant of recovery support services, including recovery community centers, and provide them with a list of recovery support service resources.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

The article introduces a comprehensive taxonomy of linkage facilitation services designed to help individuals with opioid use disorder (OUD) access treatment and recovery resources, addressing significant barriers to care.

Developed through expert consensus, the taxonomy includes eight key domains that outline the roles, activities, and goals of linkage services, aiming to standardize practices and improve research in the field of OUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linkage facilitation services for opioid use disorder: Taxonomy of facilitation practitioners, goals, and activities. Hogue, A., Satcher, MF., Drazdowski, TK., et al.[2023]

Collaboration between drug courts and medication for opioid use disorder (MOUD) providers is essential for improving access to treatment, with drug court staff favoring agencies that offer comprehensive services alongside MOUD.

Barriers to effective collaboration include logistical issues like limited provider hours and inadequate communication, as well as concerns about the prescribing practices of MOUD providers, which can hinder referrals and negatively impact participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to collaboration between drug courts and community-based medication for opioid use disorder providers. Pivovarova, E., Taxman, FS., Boland, AK., et al.[2023]

A review identified seven quality measures for treating opioid use disorder (OUD), all of which focus on the processes of service delivery, highlighting the need for better assessment of treatment outcomes and patient experiences.

There is a significant gap in quality measures specifically tailored for OUD, indicating that a unified framework, like an OUD Treatment Cascade, is necessary to improve care access and reduce opioid-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. Williams, AR., Nunes, EV., Bisaga, A., et al.[2022]

In a pilot study conducted over 8 weeks in high-risk communities in Chicago, peer outreach workers successfully linked 96% of 70 eligible individuals with opioid use disorders to methadone treatment, demonstrating the effectiveness of this intervention model.

Most participants remained in treatment at 30 and 60 days post-intake (69% and 70%, respectively), indicating that the approach not only facilitates initial access to treatment but also supports ongoing engagement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid recovery initiation: Pilot test of a peer outreach and modified Recovery Management Checkup intervention for out-of-treatment opioid users. Scott, CK., Grella, CE., Nicholson, L., et al.[2019]

The tailored telephone intervention delivered by peers (TTIP-PRO) was well-received by participants, with all eight patients finding it 'very helpful' and showing a significant increase in their knowledge about opioid overdoses, from 69.9% to 93.6% correct responses after the intervention.

While interest in starting medication-assisted treatment (MAT) increased from 8.1 to 9.5 on a 10-point scale, this change was not statistically significant, indicating that further development and testing of TTIP-PRO is needed to effectively encourage MAT enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Winhusen, T., Theobald, J., Lewis, D., et al.[2022]

The study is testing a rapid access buprenorphine program in six Washington State communities, aiming to improve access for individuals with opioid use disorder (OUD) who face barriers to treatment, particularly those who are unhoused or using syringe services.

This Community-Based Medication-First model will evaluate effectiveness by comparing outcomes like arrests and health care utilization between participants in the program and a matched comparison group, providing insights into how to better serve those with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Community-Based Medication-First program for opioid use disorder: a hybrid implementation study protocol of a rapid access to buprenorphine program in Washington State. Banta-Green, CJ., Owens, MD., Williams, JR., et al.[2022]

A new model for treating opioid use disorder (OUD) called the Recovery Community Center Office-Based Opioid Treatment model is proposed to enhance care and reduce overdose risks, building on recent community-based innovations.

The model includes specific protocols for responding to overdose and non-overdose events, but faces potential barriers such as reimbursement issues and regulatory challenges that need to be addressed in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responding to the opioid and overdose crisis with innovative services: The recovery community center office-based opioid treatment (RCC-OBOT) model. Ashford, RD., Brown, AM., McDaniel, J., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12369950/

The linkage between opioid treatment programs and recovery ... Current clinical practice guidelines advise that longer duration of MOUD use results in better outcomes. For treatment with methadone, 12 months ...

2. withpower.com withpower.com/trial/community-resource-linkage-for-opioid-use-disorder-8a543

Community Resource Linkage for Opioid Use Disorder What data supports the effectiveness of the Recovery Community Center Linkage (RCCL) treatment for opioid use disorder? Research shows that community ...

3. researchgate.net researchgate.net/publication/394394880_The_linkage_between_opioid_treatment_programs_and_recovery_community_centers_results_of_a_survey_of_OTP_directors

results of a survey of OTP directors The linkage between opioid treatment programs and recovery community centers: results of a survey of OTP directors. Frontiers in ...

4. reporter.nih.gov reporter.nih.gov/search/AYZjujtZCkW0YuYz-Xu4xw/project-details/10796930

Project Details - NIH RePORTER Also, few MOUD Ps know of or use RCCs, and clinical linkage to them is uncommon. Thus, this 5-year project seek to advance our understanding of the clinical and ...

5. jsatjournal.com jsatjournal.com/article/S2949-8759(25)00102-X/fulltext

One-stop shopping for recovery? A systematic review of the ... RCC participation duration and intensity were positively associated with improvements in substance use, recovery capital, and psychosocial functioning.

6. massgeneral.trialstoday.org massgeneral.trialstoday.org/trial/NCT07010978

Mass General - Division of Clinical Research Researchers will compare linking people to recovery community centers (RCC) to enhanced treatment as usual to see if recovery outcomes are different. In one ...

7. trialx.com trialx.com/clinical-trials/listings/322801/towards-testing-the-effectiveness-of-recovery-community-centers-rccs/

Towards Testing the Effectiveness of Recovery Community ... The current study is a pilot randomized clinical trial (RCT) comparing RCC linkage vs. enhanced treatment as usual (ETAU). Persons engaged in MOUD clinical care ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07010978?term=AREA%5BLocationSearch%5D(Massachusetts%20General%20Hospital)%20AND%20SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DUnited%20States%20AND%20AREA%5BLocationState%5DMassachusetts)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=2

Towards Testing the Effectiveness of Recovery Community ... The current study is a pilot randomized clinical trial (RCT) comparing RCC linkage vs. enhanced treatment as usual (ETAU). Persons engaged in MOUD clinical care ...