PregnancyNCT07911332
Justice Core Trial
A study testing Jail Diversion into Treatment and Referral at Release in people with Pregnancy and Substance Use Disorder (SUD), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Justice Core, an intervention that moves pregnant women with substance use disorder (SUD) from jail into community-based SUD treatment while awaiting trial, can improve the health of pregnant women compared to referring them to treatment at the time of jail release. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Substance Use Disorder (SUD), Prisoners
- What is being tested?
- Jail Diversion into Treatment and Referral at Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant
- Incarcerated pre-trail in a participating NC jail
- Meet DSM-5 criteria for mild, moderate, or severe SUD in the past 12 months
Who cannot join
- Participant has pending charges considered violent that may be incompatible with diversion
- Participant has pending charges that make diversion technically not feasible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Research Manager, 919-966-0551, jbjack@email.unc.edu
Program Manager, 919-420-9257, creag@unc.edu
About this study
Official title: Justice Core Randomized Controlled Trial
The goal of this clinical trial is to learn if Justice Core, an intervention that moves pregnant women with substance use disorder (SUD) from jail into community-based SUD treatment while awaiting trial, can improve the health of pregnant women compared to referring them to treatment at the time of jail release. The main questions it aims to answer are:
- Will the Justice Core intervention help women start and stay in SUD treatment compared to a group of women being given a treatment referral when they leave the jail?
- How does the Justice Core intervention affect pregnancy health outcomes compared with a group that is given a treatment referral when they leave the jail?
- What are the challenges in starting a new intervention, keeping it running, and the ethical issues during and after the trial?
Read more
Researchers will compare the outcomes of women who receive the Justice Core intervention with women who receive a treatment referral when they are released from jail. They will look at how many women start and continue treatment and compare pregnancy-related and incarceration outcomes.
Participants will be asked to:
- Complete a treatment assessment.
- Take part in three follow-up phone surveys.
- Some participants may also be asked to complete a longer phone interview to share more about their experiences.
- Conditions
- Pregnancy, Substance Use Disorder (SUD), Prisoners
- Being tested
- Jail Diversion into Treatment, Referral at Release
- Keywords
- pregnancy, substance use disorder, incarceration, jail, diversion, pre-trial, detention, SUD
- 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.
Jail Diversion into TreatmentOther
To provide jail diversion case management services by working with legal teams, prosecutors, and judges to facilitate pre-trial diversion into SUD treatment.
Referral at ReleaseOther
To provide case management services focused on referral to community-based SUD treatment programs and other needed reentry services at the time that a release date is known.
| Study group | Role | What they receive |
|---|---|---|
| Justice Core | Experimental | Justice Core Diversion Intervention Receives: Other: Jail Diversion into Treatment |
| Referral at Release | Active comparator | Referral at Release Receives: Other: Referral at Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of SUD treatment
Initiation of SUD treatment through inpatient, outpatient, or medication visit, reported as proportion of participants reporting initiation
Measured: Within 14 days of jail release
Engagement in SUD treatment
Two or more additional SUD services or medications, reported as proportion of participants reporting engagement
Measured: Within 48 days of jail release
Secondary outcomes (6)
Return to substance use
Use of unprescribed substances other than tobacco since the last visit, reported as proportion of participants reporting use
Measured: At 14, 48, and 90 days after jail release
Non-fatal overdose
Non-fatal overdose since the last visit, reported as proportion of participants reporting non-fatal overdose
Measured: At 14, 48, and 90 days after jail release
Fatal overdose
Date of fatal overdose, reported as proportion of participants reporting fatal overdose
Measured: At 14, 48, and 90 days after jail release
Drug-use physical morbidity
Diagnosis of skin or soft-tissue infection, hepatitis, or HIV since the last visit, reported as proportion of participants reporting any diagnosis
Measured: At 14, 48, and 90 days after jail release
Drug-use social morbidity
Damage to social relationships, finances, employment, or housing due to substance use since the last visit, reported as proportion of participants reporting any damage
Measured: At 14, 48, and 90 days after jail release
Ongoing engagement in SUD treatment
Engagement in SUD treatment in the past 34 days, reported as proportion of participants reporting ongoing engagement
Measured: At 90 days after jail release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Andrea K Knittel, MD PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911332
- Sponsor's protocol ID
- 26-1599
- Other IDs
- 1R01DA063702-01A1
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Justice Core Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07911332
- Acronym / sponsor ID
- 26-1599
- Conditions
- Pregnancy, Substance Use Disorder (SUD), Prisoners
- Keywords
- pregnancy, substance use disorder, incarceration, jail, diversion, pre-trial, detention, SUD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 2 Nov 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.
The goal of this clinical trial is to learn if Justice Core, an intervention that moves pregnant women with substance use disorder (SUD) from jail into community-based SUD treatment while awaiting trial, can improve the health of pregnant women compared to referring them to treatment at the time of jail release. The main questions it aims to answer are:
- Will the Justice Core intervention help women start and stay in SUD treatment compared to a group of women being given a treatment referral when they leave the jail?
- How does the Justice Core intervention affect pregnancy health outcomes compared with a group that is given a treatment referral when they leave the jail?
- What are the challenges in starting a new intervention, keeping it running, and the ethical issues during and after the trial?
Researchers will compare the outcomes of women who receive the Justice Core intervention with women who receive a treatment referral when they are released from jail. They will look at how many women start and continue treatment and compare pregnancy-related and incarceration outcomes.
Participants will be asked to:
- Complete a treatment assessment.
- Take part in three follow-up phone surveys.
- Some participants may also be asked to complete a longer phone interview to share more about their experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Justice Core | Experimental | Other: Jail Diversion into TreatmentJustice Core Diversion Intervention |
| Referral at Release | Active comparator | Other: Referral at ReleaseReferral at Release |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant
- Incarcerated pre-trail in a participating NC jail
- Meet DSM-5 criteria for mild, moderate, or severe SUD in the past 12 months
Key exclusion criteria (2 listed)
- Participant has pending charges considered violent that may be incompatible with diversion
- Participant has pending charges that make diversion technically not feasible
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 |
|---|---|---|
| Jail Diversion into TreatmentTo provide jail diversion case management services by working with legal teams, prosecutors, and judges to facilitate pre-trial diversion into SUD treatment. | Other | Justice Core |
| Referral at ReleaseTo provide case management services focused on referral to community-based SUD treatment programs and other needed reentry services at the time that a release date is known. | Other | Referral at Release |
Primary outcome
Initiation of SUD treatment
Time frame: Within 14 days of jail release
Initiation of SUD treatment through inpatient, outpatient, or medication visit, reported as proportion of participants reporting initiation
Engagement in SUD treatment
Time frame: Within 48 days of jail release
Two or more additional SUD services or medications, reported as proportion of participants reporting engagement
6 secondary outcomes
Return to substance use
Time frame: At 14, 48, and 90 days after jail release
Non-fatal overdose
Time frame: At 14, 48, and 90 days after jail release
Fatal overdose
Time frame: At 14, 48, and 90 days after jail release
Drug-use physical morbidity
Time frame: At 14, 48, and 90 days after jail release
Drug-use social morbidity
Time frame: At 14, 48, and 90 days after jail release
Ongoing engagement in SUD treatment
Time frame: At 90 days after jail release
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Andrea K Knittel, MD PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jail Diversion into Treatment and Referral at Release in people with Pregnancy and Substance Use Disorder (SUD), run by University of North Carolina, Chapel Hill at 1 site 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 3 inclusion and 2 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Research Manager (919-966-0551, jbjack@email.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of SUD treatment (time frame: Within 14 days of jail release). The study lists 2 primary outcomes in all. 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 2 Nov 2026.