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

145 Participants Needed

Trial Summary

What is the purpose of this trial?

The aims of the current study are to: Aim 1. Develop and refine a novel intervention protocol for individuals receiving medication treatment for opioid use disorder that assertively links them to recovery community centers; Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of assertive linkage to recovery community centers relative to a matched control condition, via a pilot randomized controlled trial; Aim 3. Explain quantitative findings by gaining an in-depth understanding of the intervention's feasibility, acceptability, and preliminary efficacy via qualitative interviews.

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 data supports the effectiveness of the Recovery Community Center Linkage (RCCL) treatment for opioid use disorder?

Research shows that community outreach and peer support interventions can effectively help people with opioid use disorder access medication-assisted treatment, which is crucial for reducing opioid-related deaths. In a study, a peer outreach program successfully engaged a majority of participants in treatment, demonstrating the potential of community-based linkage services to improve treatment access and retention. ^{1 2 3 4 5}

Is the Community Resource Linkage for Opioid Use Disorder treatment safe for humans?

The research articles reviewed do not provide specific safety data for the Community Resource Linkage for Opioid Use Disorder treatment or its related models like RCCL or CC. They focus on the effectiveness and implementation of opioid use disorder treatments, but do not mention any safety concerns. ^{5 6 7 8 9}

How is the Recovery Community Center Linkage (RCCL) treatment different from other treatments for opioid use disorder?

The Recovery Community Center Linkage (RCCL) treatment is unique because it focuses on connecting individuals with opioid use disorder to community resources and support systems, which can help overcome barriers to accessing medication-assisted treatment. This approach emphasizes linkage facilitation, which is not consistently addressed in other treatments. ^{1 2 5 9 10}

Eligibility Criteria

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

Active psychosis

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Linkage facilitation services for opioid use disorder: Taxonomy of facilitation practitioners, goals, and activities. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to collaboration between drug courts and community-based medication for opioid use disorder providers. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A community outreach intervention to link individuals with opioid use disorders to medication-assisted treatment. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. [2022]

5. England 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. [2022]

6. England 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). [2022]

8. England pubmed.ncbi.nlm.nih.gov

Linking MATTERS: Barriers and Facilitators to Implementing Emergency Department-Initiated Buprenorphine-Naloxone in Patients with Opioid Use Disorder and Linkage to Long-Term Care. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Challenges on the road to recovery: Exploring attitudes and experiences of clients in a community-based buprenorphine program in Baltimore City. [2020]

10. United States 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. [2019]