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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if resolving legal issues can aid people recovering from opioid use disorder by improving their treatment outcomes. Participants receiving treatment for substance use disorder, such as buprenorphine (known by brand names like Sublocade, Brixadi, and Suboxone), will access an online platform that addresses legal problems, such as unpaid fines or missed court dates. This support may help them secure jobs and housing. The trial will compare participants using the platform with those who do not to assess its impact on recovery and life stability. Individuals currently receiving treatment for substance use disorder are well-suited for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for recovery and life improvement.

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 prior data suggests that this online platform technology is safe for resolving legal issues?

Research has shown that using technology to assist people with opioid use disorder in handling legal issues is generally safe. The goal is to provide an online platform that helps users solve legal problems without a lawyer. Since this is not a drug or medical treatment, safety risks remain very low. The primary concern might be the platform's user-friendliness, but no reports indicate harm from this type of technology. In this trial, the treatment involves an online tutorial, which is considered low risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on removing barriers to recovery for people with opioid use disorder through an innovative approach. Unlike conventional treatments that often emphasize medication-assisted therapies, such as methadone or buprenorphine, this trial explores the potential of providing a tutorial for free online legal resolution at treatment centers. This approach aims to address legal challenges that can hinder recovery, offering a supportive resource that is not typically part of standard care. By tackling legal obstacles, the method could complement existing treatments and enhance overall recovery outcomes.

What evidence suggests that resolving legal issues could be effective for improving outcomes in opioid use disorder treatment?

This trial will compare the effects of providing a tutorial for free online legal resolution at a treatment center with a control group that does not receive this intervention. Research has shown that solving legal problems can improve treatment outcomes for people with opioid addiction. Studies have found that legal issues, such as fines or court appearances, can hinder treatment retention. Addressing these problems can help individuals secure stable jobs and housing, supporting long-term recovery. Online tools that guide people through legal steps have reduced these obstacles. By addressing legal challenges, individuals in recovery may have a better chance of avoiding relapse and improving overall life stability. ^{4 5 6 7 8}

Who Is on the Research Team?

David Cordva, PhD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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Because the regulatory and administrative barriers to treatment are high, only about 11% of people with OUD receive effective medications, ...

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healthaffairs.org

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Research has shown that ED-prescribed buprenorphine for OUD is safe, and cost-effective and improves long-term patient outcomes. Bundling low- ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6585403/

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The rate of relapse by the end of 24 weeks was 57% on buprenorphine versus 65% on injection naltrexone. Most of this difference could be accounted for by the ...

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onlinelibrary.wiley.com/doi/10.1111/add.70127

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indivior.com

indivior.com/en/media/press-releases/indivior-highlight-growing-body-of-data-on-sublocade

Press Release

These data add to the growing body of evidence that SUBLOCADE can improve outcomes, such as abstinence, retention, and recovery in persons with OUD.