- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07700407
Preventing Overdose and Promoting Recovery Through Court Navigation (POPCORN)
10. juli 2026 opdateret af: Bradley Ray, RTI International
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
600
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Bradley Ray, PhD
- Telefonnummer: 919-324-5492
- E-mail: bradleyray@rti.org
Undersøgelse Kontakt Backup
- Navn: Cari Megerian, MPH
- Telefonnummer: 415-412-0830
- E-mail: cmegerian@rti.org
Studiesteder
-
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Indiana
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South Bend, Indiana, Forenede Stater, 46601
- St. Joseph County Courthouse 1
-
Kontakt:
- Bradley Ray, PhD
- Telefonnummer: 919-324-5492
- E-mail: bradleyray@rti.org
-
Kontakt:
- Cari Megerian, MPH
- Telefonnummer: 415-412-0830
- E-mail: cmegerian@rti.org
-
-
North Carolina
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Research Triangle Park, North Carolina, Forenede Stater, 27709
- RTI International
-
Kontakt:
- Bradley Ray, PhD
- Telefonnummer: 919-324-5492
- E-mail: bradleyray@rti.org
-
Kontakt:
- Cari Megerian, MPH
- Telefonnummer: 415-412-0830
- E-mail: cmegerian@rti.org
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Has been sentenced to incarceration in jail or prison for the next 12 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Peer court navigation
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.
|
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.
|
|
Aktiv komparator: Information only
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.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Administratively documented substance use disorder treatment engagement
Tidsramme: 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.
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90 days after baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with a fatal or nonfatal overdose
Tidsramme: 12 months after baseline
|
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.
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12 months after baseline
|
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Number of participants with a jail booking or prison entry
Tidsramme: 12 months after baseline
|
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.
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12 months after baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. maj 2030
Datoer for studieregistrering
Først indsendt
3. juli 2026
Først indsendt, der opfyldte QC-kriterier
10. juli 2026
Først opslået (Faktiske)
14. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01DA064492 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
IPD and additional supporting information will be archived in the National Addiction & HIV Data Archive Program (NAHDAP), assigned persistent identifiers, and made available as soon as possible and no later than the earlier of the primary publication or the end of the performance period, whichever comes first.
IPD-delingsadgangskriterier
After project completion, only de-identified datasets will be made available as public-use files and deposited in repositories for broader research, teaching, replication.
Shared data will be provided in open, non-proprietary formats, along with parallel Stata/R scripts and a README so that no specialized software is required to access or manipulate the data.
Publicly shared datasets will receive a DOI to facilitate sharing, citation, and version control.
Access will be controlled when there is any non-trivial re-identification risk or when required by data use agreements.
In those cases, repositories will gate access under standard data use agreements that prohibit re-identification and onward sharing, require secure storage and destruction at project end, and log requestor credentials and approved uses.
Raw state administrative source files received under data use agreements will not be shared; only de-identified, derived variables constructed from those sources will be deposited.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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