Opioid Use DisorderCROSSROADSNCT07216963
The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study
A study testing CROSSROADS in people with Opioid Use Disorder and Overdose, Drug, run by Duke University at 4 sites in United States.
Trial summary
The goal of this clinical trial is to develop and test the CROSSROADS intervention. CROSSROADS is designed for people who have recently survived an opioid and/or stimulant-related non-fatal overdose and had contact with staff from a Community Paramedic (CP) program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Overdose, Drug, Overdose
- What is being tested?
- CROSSROADS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2027to 1 Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older;
- Has interacted with a CP team (and, thus, experienced a non-fatal opioid and/or stimulant overdose) in the last 30 days;
- Has independent legal agency
- Able to independently provide informed consent; and
- Able to speak and understand English.
Who cannot join
- Active, severe, and untreated mental illness that would make providing consent impossible
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Boston Medical Center
Boston, Massachusetts, 02118
Alysse Wurcel, MD
Duke University
Durham, North Carolina, 27701
Margaret Roach, MPH, 919-660-3008, margaret.roach@duke.edu
Lauren Brinkley-Rubinstein, PhD
University of Miami
Miami, Florida, 33146
Kathryn Nowotny, PhD
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Emily Dauria, PhD
About this study
Official title: The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services (CROSSROADS) Study
The goal of this clinical trial is to develop and test the CROSSROADS intervention. CROSSROADS is designed for people who have recently survived an opioid and/or stimulant-related non-fatal overdose and had contact with staff from a Community Paramedic (CP) program.
Participants will be randomly placed into one of two groups:
Read more
- Standard of care from the CP program, or 2) CROSSROADS, which includes CP care plus a Medical-Legal Partnership (MLP). The MLP helps people with legal problems that can affect their health-- like issues with housing or public benefits.
Researchers will test if the CROSSROADS intervention reduces drug use and involvement with the criminal legal system.
People in the study will be followed for one year and asked to complete surveys at the beginning, and again at 1 month, 6 months, and 12 months.
Read the detailed description
CROSSROADS is a Hybrid Type I Implementation Effectiveness Trial. The primary objective of the study is to examine how the CROSSROADS intervention, which incorporates a Medical-Legal Partnership (MLP) into community paramedic (CP) standard of care, addresses health-harming legal needs (HHLN) influencing adverse substance use outcomes and risk of CLS (Criminal Legal System) engagement.
The key component of the CROSSROADS intervention is that it directly identifies and addresses HHLN. The MLP utilized in this study is Docs for Health (D4H), a technology-supported mobile application MLP that utilizes a 'screen and intervene' approach.
The primary aim is to compare the CROSSROADS intervention versus standard of care (SOC) CP programs across four sites (Durham, NC; Miami, FL; Pittsburgh, PA; Portland, ME) on 1) frequency of opioid and stimulant use, and 2) CLS (police, incarceration, and probation/parole) involvement. Researchers will randomly assign 400 adults to the SOC CP program (n=200) or CROSSROADS (n=200). Follow-up will occur at 1, 6, and 12 months.
The focus of the study is to examine how Community paramedic programs addressing socio-structural-legal factors influence adverse substance use outcomes and risk of criminal legal engagement. The long-term goal is to assess how innovative non-carceral interventions can be best implemented to address adverse substance use outcomes and prevent CLS exposure.
- Being tested
- Community Paramedic Standard of Care (CP SOC), CROSSROADS
- Keywords
- Overdose, Community Paramedic, Medical-Legal Services, Criminal Legal System, Consolidated Framework for Implementation Research, Paramedical Personnel, Human Centered Design, Criminal Legal
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Paramedic Standard of Care (CP SOC)Behavioural
Participants randomized to CP SOC will receive 1) community paramedic standard of care after initial response to overdose; 2) Medications for Opioid Use Disorder (MOUD), harm reduction referrals, and linkages to health and social programs as needed; 3) long-term follow-up care with community paramedics in the field after initial contact.
CROSSROADSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Paramedic Standard of Care (CP SOC) | Active comparator | 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. Receives: Behavioral: Community Paramedic Standard of Care (CP SOC) |
| CROSSROADS | Experimental | 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. Receives: Behavioral: CROSSROADS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of opioid and/or stimulant use
As measured by the number of days of use per month per participant.
Measured: 12 months
Number of participants with opioid and/or stimulant use
As measured by Urine Drug Screen (UDS).
Measured: 12 months
Number of participants with Criminal Legal System Involvement
Measured by the number of participants with criminal legal system involvement. Criminal legal system involvement includes all intercepts of the Sequential Intercept Model: police/arrest, jail, court, prison, and community supervision.
Measured: 12 months
Secondary outcomes (8)
Presence of Health Harming Legal Needs (HHLN)
Measured by the National Center for MLP HHLN Scale, which measures HHLN including income, education \& employment, legal status, and personal stability. The scale "score" is the number of positive responses, indicating the number of identified legal needs a patient has on the screening tool.
Measured: 12 months
Number of participants with risky substance use behaviors
Measured by the HIV Risk-taking Behavior Scale (HRBS). The HRBS provides three scores: a total score indicating level of HIV risk-taking behavior; a Drug Use Sub-total indicating level of risk due to drug taking practices; and a Sexual Behavior Sub-total indicating level of risk associated with unsafe sex. The higher the total score, the greater the risk the subject has of contracting and passing on HIV.
Measured: 12 months
Risk of overdose as measured by the Opioid Overdose Risk Behavior Scale, version 2 (ORBS-2)
The total score on the ORBS-2 indicates the level of risk, with a higher score signifying a greater risk of overdose.
Measured: 12 months
Number of participants who experienced a non-fatal overdose as measured by health record
Non-fatal overdoses measured by administrative/health records.
Measured: 12 months
Number of participants who experienced a fatal overdose
Fatal overdoses are measured by administrative/health records.
Measured: 12 months
Treatment utilization
Number of participants who utilized treatment services
Measured: 12 months
Prevention service utilization
Number of participants who utilized overdose prevention services
Measured: 12 months
HHLN Service Utilization
Number of participants who utilized HHLN (Health Harming Legal Needs) ameliorative services
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start1 Feb 2027 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Lauren Brinkley-Rubinstein, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216963
- Sponsor's protocol ID
- Pro00118502
- Other IDs
- RM1DA064518
- Acronym
- CROSSROADS
- Status last verified
- Apr 2026
- First submitted
- 7 Oct 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No