Substance Use Disorder (SUD)POPCORNNCT07700407
Preventing Overdose and Promoting Recovery Through Court Navigation
A study testing CourtConnect and Information Only in people with Substance Use Disorder (SUD), run by RTI International at 2 sites in United States.
Trial summary
This project is a hybrid type I clinical trial to assess the effectiveness and implementation determinants of a peer-led court navigation program for people who use drugs and are passing through county courthouses. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- CourtConnect and Information Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Current resident of Indiana
- Able to complete study procedures in English
- Meets at least one of the following criteria: used heroin, fentanyl, methamphetamine, or cocaine in the past 12 months; is interested in resources or treatment for a substance use disorder; or experienced an opioid-related overdose in the past 12 months
Who cannot join
- Has been sentenced to incarceration in jail or prison for the next 12 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
RTI International
Research Triangle Park, North Carolina, 27709
Bradley Ray, PhD, 919-324-5492, bradleyray@rti.org
Cari Megerian, MPH, 415-412-0830, cmegerian@rti.org
St. Joseph County Courthouse 1
South Bend, Indiana, 46601
Bradley Ray, PhD, 919-324-5492, bradleyray@rti.org
Cari Megerian, MPH, 415-412-0830, cmegerian@rti.org
About this study
Official title: Hybrid Type I Trial of a Peer-Led Court Navigation Program to Improve Substance Use Disorder Treatment Receipt and Reduce Overdose and Incarceration Among People Passing Through Courthouses
This project is a hybrid type I clinical trial to assess the effectiveness and implementation determinants of a peer-led court navigation program for people who use drugs and are passing through county courthouses. Courthouses are a common point of contact for people with behavioral health needs, but outside of specialty court models, they remain underexplored as a setting for connecting people to substance use disorder treatment and related services. This study will test whether court navigation led by peer recovery specialists can increase receipt of substance use disorder treatment and reduce overdose and incarceration. Peer court navigators will meet with participants in courthouse settings, assess their needs, provide information and referrals, and offer follow-up support for up to 3 months. Peer recovery specialists, who have lived experience with substance use recovery, are increasingly being integrated into criminal legal and community-based settings; however, peer-led court navigation remains an innovative and understudied approach.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- CourtConnect, Information Only
- Keywords
- court navigation, peer recovery coach, substance use disorder treatment, fatal overdose, nonfatal overdose, incarceration, jail booking, prison entry, criminal legal system
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CourtConnectBehavioural
CourtConnect connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs. Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months.
Information OnlyOther
Participants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant. They do not receive peer court navigation or follow-up support from a peer court navigator.
| Study group | Role | What they receive |
|---|---|---|
| Peer court navigation | Experimental | CourtConnect is the intervention. It connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs. Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months. Receives: Behavioral: CourtConnect |
| Information only | Active comparator | Participants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant. They do not receive peer court navigation or follow-up support from a peer court navigator. Receives: Other: Information Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administratively documented substance use disorder treatment engagement
This participant-level outcome will indicate whether a participant has any administratively documented substance use disorder treatment engagement within 90 days after baseline. Treatment engagement will be determined from linked state administrative records, including Medicaid claims for substance use disorder treatment services and prescription drug monitoring program records showing dispensed medications used to treat substance use disorder. For participants without administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as treatment initiation. For participants with administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as continued treatment engagement. The outcome will be reported as the proportion of participants in each study arm with administratively documented treatment engagement.
Measured: 90 days after baseline
Secondary outcomes (2)
Number of participants with a fatal or nonfatal overdose
Fatal and nonfatal overdose will be measured using statewide vital records and emergency medical records from ambulance services and hospital emergency departments. Participants will be classified as having experienced an overdose if records show a fatal overdose or an encounter for a nonfatal overdose during the 12 months after baseline.
Measured: 12 months after baseline
Number of participants with a jail booking or prison entry
Incarceration through jail booking or prison entry will be measured using statewide criminal legal records. Participants will be classified as having experienced incarceration if records show a booking into a jail facility or entry into the state prison system during the 12 months after baseline.
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Bradley Ray, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700407
- Sponsor's protocol ID
- R01DA064492
- Other IDs
- R01DA064492
- Acronym
- POPCORN
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will enroll 600 subjects over 24 months with 12 months of follow-up data by linking administrative records (e.g., prescription fills, emergency department/emergency medical services encounters, mortality, arrests/jail bookings) to survey contents that will include demographics, substance use disorder and treatment history, criminal legal system involvement, social constructs (self-efficacy, motivation, stigma), and harmonized measures. The National Institutes of Health requires that the study team release study data. The investigators will preserve and share de-identified survey datasets (with codebooks), and project documentation (protocols, instruments); derived variables from linked administrative data will be shared, while raw state administrative source files obtained under data use agreements will not be shared. The publicly released scientific data will include only fully de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Type I Trial of a Peer-Led Court Navigation Program to Improve Substance Use Disorder Treatment Receipt and Reduce Overdose and Incarceration Among People Passing Through Courthouses
- ClinicalTrials.gov ID
- NCT07700407
- Acronym / sponsor ID
- POPCORN / R01DA064492
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- court navigation, peer recovery coach, substance use disorder treatment, fatal overdose, nonfatal overdose, incarceration, jail booking, prison entry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a hybrid type I clinical trial to assess the effectiveness and implementation determinants of a peer-led court navigation program for people who use drugs and are passing through county courthouses. Courthouses are a common point of contact for people with behavioral health needs, but outside of specialty court models, they remain underexplored as a setting for connecting people to substance use disorder treatment and related services. This study will test whether court navigation led by peer recovery specialists can increase receipt of substance use disorder treatment and reduce overdose and incarceration. Peer court navigators will meet with participants in courthouse settings, assess their needs, provide information and referrals, and offer follow-up support for up to 3 months. Peer recovery specialists, who have lived experience with substance use recovery, are increasingly being integrated into criminal legal and community-based settings; however, peer-led court navigation remains an innovative and understudied approach.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer court navigation | Experimental | Behavioral: CourtConnectCourtConnect is the intervention. It connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs. Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months. |
| Information only | Active comparator | Other: Information OnlyParticipants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant. They do not receive peer court navigation or follow-up support from a peer court navigator. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Current resident of Indiana
- Able to complete study procedures in English
- Meets at least one of the following criteria: used heroin, fentanyl, methamphetamine, or cocaine in the past 12 months; is interested in resources or treatment for a substance use disorder; or experienced an opioid-related overdose in the past 12 months
Key exclusion criteria (1 listed)
- Has been sentenced to incarceration in jail or prison for the next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CourtConnectCourtConnect connects individuals in courthouses with peer court navigators who provide information, referrals, and support to address substance use disorder treatment needs and related health and social needs. Navigation begins in the courthouse and continues in the community through follow-up support for up to 3 months. | Behavioural | Peer court navigation |
| Information OnlyParticipants assigned to the information-only group receive information about health and social services in the community from a non-peer research assistant. They do not receive peer court navigation or follow-up support from a peer court navigator. | Other | Information only |
Primary outcome
Administratively documented substance use disorder treatment engagement
Time frame: 90 days after baseline
This participant-level outcome will indicate whether a participant has any administratively documented substance use disorder treatment engagement within 90 days after baseline. Treatment engagement will be determined from linked state administrative records, including Medicaid claims for substance use disorder treatment services and prescription drug monitoring program records showing dispensed medications used to treat substance use disorder. For participants without administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as treatment initiation. For participants with administratively documented substance use disorder treatment during the 90 days before baseline, a qualifying post-baseline record will be classified as continued treatment engagement. The outcome will be reported as the proportion of participants in each study arm with administratively documented treatment engagement.
2 secondary outcomes
Number of participants with a fatal or nonfatal overdose
Time frame: 12 months after baseline
Number of participants with a jail booking or prison entry
Time frame: 12 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators will enroll 600 subjects over 24 months with 12 months of follow-up data by linking administrative records (e.g., prescription fills, emergency department/emergency medical services encounters, mortality, arrests/jail bookings) to survey contents that will include demographics, substance use disorder and treatment history, criminal legal system involvement, social constructs (self-efficacy, motivation, stigma), and harmonized measures. The National Institutes of Health requires that the study team release study data. The investigators will preserve and share de-identified survey datasets (with codebooks), and project documentation (protocols, instruments); derived variables from linked administrative data will be shared, while raw state administrative source files obtained under data use agreements will not be shared. The publicly released scientific data will include only fully de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CourtConnect and Information Only in people with Substance Use Disorder (SUD), run by RTI International at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bradley Ray, PhD (919-324-5492, bradleyray@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Administratively documented substance use disorder treatment engagement (time frame: 90 days after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.