Community Partnering for Opioid Use Disorder

(RB Trial)

Recruiting at 1 trial location

Overseen By David Cordova, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Not receiving treatment

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

800 Participants Needed

Trial Summary

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 focuses on resolving legal issues to improve treatment outcomes for opioid use disorder.

What data supports the effectiveness of the drug buprenorphine for treating opioid use disorder?

Research shows that buprenorphine, including its extended-release form Sublocade, is effective in treating opioid use disorder. Studies highlight its benefits in reducing opioid use and improving access to treatment, especially in community-based and rural settings. ^{1 2 3 4 5}

Is buprenorphine generally safe for humans?

Buprenorphine is generally considered safe for treating opioid use disorder, with adverse effects being mild and rare. However, some clinical experiences suggest that side effects might be more significant than typically recognized, potentially affecting patient trust and care. ^{1 2 6 7 8}

How is the drug used in the Community Partnering for Opioid Use Disorder trial different from other treatments for opioid use disorder?

This drug, which includes options like Sublocade and Suboxone, is unique because it can be administered as a long-acting injection, potentially improving patient retention and reducing opioid use and overdose compared to standard sublingual (under the tongue) treatments. ^{1 2 3 5 6}

What is the purpose of this trial?

The opioid epidemic has become one of America's deadliest crises, surpassing car crashes, firearms, and HIV/AIDS as a leading cause of death for Americans under fifty years of age. People trying to recover from opioid-use disorder face many obstacles. Obstacles such as minor legal problems (e.g., arrest warrants for failure to pay a fine, failure to appear in court, or late child support payments) can undermine the stability needed to overcome opioid dependence. Outstanding legal obligations make it difficult to find jobs and to secure housing. They can result in removal from treatment programs as well as incarceration. Resolving these legal problems requires coordination, organization, preparation, travel, and time-expectations that may be problematic for many people in the early stages of recovery. Technology has the potential to make resolving these legal problems much easier. Online platform technology is now available that can guide people in recovery through the resolution of many legal problems at no cost and without an attorney, potentially doing so quickly, remotely, and at any time of day. This study of individuals in treatment in Michigan tests whether resolving outstanding legal issues improves drug treatment outcomes. The research also examines whether and to what extent resolving legal issues supports family reunification, reduces future criminal behavior, and improves access to jobs and housing for clients in treatment for opioid use disorder. A randomized controlled trial (RCT) is used to determine the effects of resolving legal issues on these outcomes. For identification, the investigators leverage the random assignment of legal services to treatment center clients, along with the random assignment of clients to treatment centers by birth month. We assemble a novel longitudinal dataset of hundreds of clients in treatment for substance use disorder and link these clients to several administrative datasets and qualitative data, which allows for measurement of: (1) substance use behaviors and (2) justice-system involvement, including civil and criminal legal system encounters. This study also uses linked client and administrative data to research the population in opioid treatment centers, follow-up behaviors, and whether the consequences of providing no-cost legal services differ by client background. Findings from this research will improve America's understanding of the acute socio-legal needs faced by those experiencing opioid use disorder and provide recommendations to help target resources toward the areas that best support long-term abstinence from opioids and other drugs.

Research Team

David Cordva, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

This trial is for individuals currently receiving treatment for substance use disorders, specifically those struggling with opioid addiction and related challenges like alcoholism, risky behaviors, criminal activity, and housing insecurity. It's not open to people who aren't in such treatment programs.

Inclusion Criteria

Receiving substance use disorder treatment services

Exclusion Criteria

Not receiving substance use disorder treatment services

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tutorial for free online legal resolution at treatment center

Varies

Follow-up

Participants are monitored for substance use behaviors and justice-system involvement

2 years

Treatment Details

Interventions

• Removing Barriers to Recovery

Trial Overview The study tests if resolving legal issues through an online platform can improve drug treatment outcomes. Participants are randomly assigned to receive legal services or not, which helps determine the impact on family reunification, job access, housing stability, and reduced criminal behavior.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Receives tutorial for free online legal resolution at treatment center

Group II: Control Active Control 1 Intervention

The control group is not provided the experimental intervention.

Removing Barriers to Recovery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Buprenorphine for:

• Opioid use disorder
• Severe pain

Approved in European Union as Buprenorphine for:

• Opioid dependence
• Severe pain

Approved in Canada as Buprenorphine for:

• Opioid use disorder
• Severe pain

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

U.S. National Science Foundation

Collaborator

Trials

35

Recruited

9,000+

Findings from Research

The Mobile Community-based Access Team (M-CAT) pilot program successfully provided buprenorphine (BUP) treatment to veterans experiencing homelessness, showing potential to increase treatment engagement in this high-risk population.

While retention in treatment was lower in M-CAT (19.2 months) compared to the usual BUP clinic (36 months), a significant 66.7% of M-CAT participants remained on BUP at the study's endpoint, indicating that mobile technology can help facilitate access to essential opioid use disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile, Community-Based Buprenorphine Treatment for Veterans Experiencing Homelessness With Opioid Use Disorder: A Pilot, Feasibility Study. Iheanacho, T., Payne, K., Tsai, J.[2022]

In a study of 533 participants over 18 months after stopping extended-release buprenorphine injection (BUP-XR), 47% reported sustained opioid abstinence, with higher rates of abstinence linked to longer treatment durations.

More than 60% of participants showed stable or improved outcomes in health-related quality of life and mental health scores, indicating that BUP-XR has a long-term positive impact on recovery from opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. Boyett, B., Nadipelli, VR., Solem, CT., et al.[2023]

In a study involving 546 buprenorphine prescribers across six U.S. jurisdictions, only 54% of Medicaid patients and 62% of uninsured patients were offered new appointments for buprenorphine treatment, indicating significant barriers to access for those seeking help for opioid use disorder.

Despite these barriers, the median wait times for appointments were relatively short, at around 6 days for Medicaid patients and 5 days for uninsured patients, suggesting that there is potential to improve access to treatment by better utilizing the existing prescriber workforce.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Office-Based Buprenorphine Treatment in Areas With High Rates of Opioid-Related Mortality: An Audit Study. Beetham, T., Saloner, B., Wakeman, SE., et al.[2021]

Participation in the MOUD ECHO program significantly increased the likelihood of rural primary care providers achieving key prescribing benchmarks for buprenorphine, including obtaining training and licensure, starting to prescribe, and adding patients to their panels.

The study involved 80 providers over a 2-year period and demonstrated that increased attendance at MOUD ECHO sessions correlates with improved implementation of buprenorphine treatment for Opioid Use Disorder, highlighting the program's effectiveness in addressing treatment access barriers in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of MOUD ECHO Participation on Expansion of Buprenorphine Prescribing in Rural Primary Care. Salvador, JG., Myers, OB., Bhatt, SR., et al.[2023]

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 52-week randomized controlled trial involving 952 veterans is comparing the effectiveness of long-acting injectable buprenorphine (INJ-BUP) to standard sublingual buprenorphine/naloxone (SL-BUP/NLX) for treating opioid use disorder (OUD).

The study aims to determine if INJ-BUP improves retention in medication treatment and reduces opioid use, which could lead to better health outcomes and potentially save lives among veterans struggling with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans. Petrakis, I., Springer, SA., Davis, C., et al.[2022]

Increasing access to buprenorphine, a treatment for opioid use disorder, is crucial for reducing overdose deaths, but limited availability of buprenorphine monoproduct is a significant barrier.

The requirement to prescribe buprenorphine as a combination product with naloxone may lead to adverse effects that are more serious than previously thought, potentially harming the patient-provider relationship and increasing stigma, which can hinder access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? Gregg, J., Hartley, J., Lawrence, D., et al.[2023]

The low-threshold group-based MOUD program at a federally qualified health center in Philadelphia effectively increased patient access and retention through its person-centered harm reduction approach and integration into primary care.

Challenges included varying staff acceptance of harm reduction principles and the need to manage clinic workflow, highlighting the importance of understanding both strengths and challenges for similar programs in other clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. Lai, S., Li, E., Silverio, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Mobile, Community-Based Buprenorphine Treatment for Veterans Experiencing Homelessness With Opioid Use Disorder: A Pilot, Feasibility Study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. [2023]

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

Access to Office-Based Buprenorphine Treatment in Areas With High Rates of Opioid-Related Mortality: An Audit Study. [2021]

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

Association of MOUD ECHO Participation on Expansion of Buprenorphine Prescribing in Rural Primary Care. [2023]

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

Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? [2023]

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

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. [2022]