CROSSROADS for Overdose

(CROSSROADS Trial)

Not yet recruiting at 3 trial locations

Overseen By Margaret Roach, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Severe untreated mental illness

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CROSSROADS, designed for individuals who have recently survived an opioid or stimulant overdose. Participants will receive either standard care from community paramedics or the CROSSROADS treatment, which addresses legal issues affecting health, such as housing problems. The goal is to determine if CROSSROADS can reduce drug use and legal troubles over time. Individuals who have recently overdosed and interacted with community paramedics are ideal candidates for this study. As an unphased trial, this study provides a unique opportunity to access innovative support that could significantly enhance the recovery journey.

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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the CROSSROADS intervention is safe?

Research has shown that the CROSSROADS program enhances the usual care provided by community paramedics by incorporating a Medical-Legal Partnership (MLP) to address legal issues affecting health. Although specific safety data for the CROSSROADS program is limited, its components, such as community paramedic care, are well-known and trusted. This suggests the program is likely safe and well-tolerated.

The CROSSROADS program aims to assist overdose survivors by reducing drug use and legal system involvement. By integrating legal support into health care, the program addresses issues like housing and benefits that impact health. Participants in similar programs have generally tolerated these services well, with no major reports of negative effects from addressing legal needs in this manner.

Since the study is in a "not applicable" phase, the program may be in early testing or based on existing safe practices. While direct safety data for the CROSSROADS program is not available, the use of well-established health and legal support indicates it is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CROSSROADS intervention because it goes beyond the standard of care for overdose response by integrating technology-supported medical-legal partnerships (MLP). While typical treatments involve community paramedics providing medications and referrals, CROSSROADS adds a unique layer by using Docs for Health (D4H) to directly identify and address health-harming legal needs. This innovative approach aims to tackle the social and legal issues that often accompany substance use disorders, potentially leading to more comprehensive and lasting recovery solutions.

What evidence suggests that the CROSSROADS intervention could be effective for reducing drug use and criminal legal system involvement?

Research has shown that addressing legal issues can improve health for individuals who have survived drug overdoses. In this trial, participants in the CROSSROADS arm will receive a Medical-Legal Partnership (MLP) to address legal problems that might impact health. This approach aims to reduce drug use and legal issues. Studies suggest that individuals with better access to legal help often experience fewer health problems. The CROSSROADS program builds on this concept to determine if it can help individuals remain safer and healthier after an overdose. Meanwhile, participants in the Community Paramedic Standard of Care (CP SOC) arm will receive standard care, which includes overdose response, Medications for Opioid Use Disorder (MOUD), harm reduction service referrals, and long-term follow-up care. ^{1 2 3 6 7}

Who Is on the Research Team?

Lauren Brinkley-Rubinstein, PhD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for individuals who have recently survived an opioid or stimulant-related non-fatal overdose and interacted with a Community Paramedic program. Participants will be followed for one year, completing surveys at set intervals.

Inclusion Criteria

I can legally make my own decisions.

I can understand and agree to the study on my own.

I am 18 years old or older.

Exclusion Criteria

Active, severe, and untreated mental illness that would make providing consent impossible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the standard of care from the Community Paramedic program or the CROSSROADS intervention, which includes a Medical-Legal Partnership to address health-harming legal needs.

12 months

Surveys at baseline, 1 month, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on substance use and criminal legal system involvement.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CROSSROADS

Trial Overview The study compares two approaches: standard care from the Community Paramedic program versus CROSSROADS intervention, which adds Medical-Legal Partnership support to address legal issues impacting health.

How Is the Trial Designed?

Group I: CROSSROADS Experimental Treatment 1 Intervention

The community paramedic (CP) standard of care (SOC) has three basic components across the sites. The core components of the CP SOC are that CPs: 1) are deployed via 911 as an opioid and/or stimulant overdose response; 2) provide Medications for Opioid Use Disorder (MOUD), harm reduction service referrals, and link patients to health and social programs as needed; and 3) provide long-term follow-up care in the field after initial contact. The CROSSROADS intervention will utilize these SOC aspects and build in technology-supported medical-legal partnerships (MLP) via Docs for Health (D4H) that identifies and addresses health-harming legal needs (HHLN). While CP SOC may refer to services that address some HHLN, the key component of the CROSSROADS intervention is the direct identification and addressing of HHLN via D4H.

Group II: Community Paramedic Standard of Care (CP SOC) Active Control 1 Intervention

The community paramedic (CP) standard of care (SOC) has three basic components across all study sites. The core components of the CP SOC are that CPs: 1) are deployed via 911 as an opioid and/or stimulant overdose response; 2) provide Medications for Opioid Use Disorder (MOUD), harm reduction service referrals, and link patients to health and social programs as needed; and 3) provide long-term follow-up care in the field after initial contact.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07216963

The Community Paramedic Response and Overdose ... Non-fatal overdoses measured by administrative/health records. 12 months. Number of participants who experienced a fatal overdose, Fatal ...

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-8-2026-c8039

CROSSROADS for Overdose · Info for Participants ... Abuse, Drug Overdose, Overdose and Substance Abuse. Learn more about the study. ... Participants are monitored for safety and effectiveness after treatment ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10262258/

At the Crossroads in the Opioid Overdose Epidemic 750), examined the effects of police drug seizures on overdose in Indianapolis, Indiana, and found a consistent pattern of increased drug overdoses. The authors ...

4. brookings.edu brookings.edu/articles/progress-under-threat-the-future-of-overdose-prevention-in-the-united-states/

Progress under threat: The future of overdose prevention in ... ... overdose risk, have access to naloxone. These are all positive steps. However, CDC SUDORS data indicates that 42.6% of fatal overdoses ...

5. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2025.00346

Indiana Adults Who Participated In Treatment Court ... Recently released incarcerated people are up to 129 times more likely to die from an overdose event than the general population, especially if ...

6. ochsnerjournal.org ochsnerjournal.org/content/early/2024/05/02/toj.23.0074

At a Crossroads: Opioid Use Disorder, the X-Waiver, and ... A retrospective study of health datasets found that buprenorphine/naloxone was associated with lower illicit abuse or accidental overdose- ...

7. researchgate.net researchgate.net/publication/371972785_At_the_Crossroads_in_the_Opioid_Overdose_Epidemic_Will_Evidence-Based_Radical_but_Rational_Drug_Policy_Strategies_Prevail

At the Crossroads in the Opioid Overdose Epidemic At the Crossroads in the Opioid Overdose Epidemic: Will Evidence-Based "Radical" but Rational Drug Policy Strategies Prevail? July 2023; American Journal of ...