ClinicalTrials.gg
Not yet recruitingNCT07911332Updated Nov 2, 2026

Justice Core Trial

An interventional study of Jail Diversion into Treatment and Referral at Release in Pregnancy, Substance Use Disorder (SUD) and Prisoners, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment

Updated Nov 2, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Substance-Related Disorders by University of North Carolina, Chapel Hill — 2 open to participants now, 2 under way, none of them phase 3. Substance-Related Disorders · University of North Carolina, Chapel Hill.

Planned enrollment
2nd of 14
300 · median 85
Started
2026
the only one that year
No phase
11 of 16
2 open now
Registered
16th of 16
by date

Among the 16 studies in Substance-Related Disorders by University of North Carolina, Chapel Hill, this one is the 2nd largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2026, is one of 11 with no phase, and was the 16th registered.

Substance-Related Disorders

2,241 studies on the registry are indexed under Substance-Related Disorders; 410 are open to participants now.

Browse Substance-Related Disorders studies →

Open to participants now

2 of the 16 studies in Substance-Related Disorders by University of North Carolina, Chapel Hill are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 265 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 117 (44%) stop at 75 or younger; 55 take children under 18; 89 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Substance-Related Disorders by University of North Carolina, Chapel Hill, or all of them as a file.
02

Study 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. 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.
03

Conditions studied

  • Pregnancy
  • Substance Use Disorder (SUD)
  • Prisoners

Keywords

  • pregnancy
  • substance use disorder
  • incarceration
  • jail
  • diversion
  • pre-trial
  • detention
  • SUD
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant
  • Incarcerated pre-trail in a participating NC jail
  • Meet criteria for mild, moderate, or severe SUD in the past 12 months

Exclusion criteria

Exclusion Criteria:

  • Participant has pending charges considered violent that may be incompatible with diversion
  • Participant has pending charges that make diversion technically not feasible
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Justice Core

    Justice Core Diversion Intervention

    Other: Jail Diversion into Treatment

  • Active comparator
    Referral at Release

    Referral at Release

    Other: Referral at Release

Interventions

  • OtherJail Diversion into Treatment

    To provide jail diversion case management services by working with legal teams, prosecutors, and judges to facilitate pre-trial diversion into SUD treatment.

  • OtherReferral at Release

    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.

06

What researchers measure

Primary outcomes

  1. Initiation of SUD treatment

    Initiation of SUD treatment through inpatient, outpatient, or medication visit, reported as proportion of participants reporting initiation

    Time frame: Within 14 days of jail release

  2. Engagement in SUD treatment

    Two or more additional SUD services or medications, reported as proportion of participants reporting engagement

    Time frame: Within 48 days of jail release

Secondary outcomes

  1. Return to substance use

    Use of unprescribed substances other than tobacco since the last visit, reported as proportion of participants reporting use

    Time frame: At 14, 48, and 90 days after jail release

  2. Non-fatal overdose

    Non-fatal overdose since the last visit, reported as proportion of participants reporting non-fatal overdose

    Time frame: At 14, 48, and 90 days after jail release

  3. Fatal overdose

    Date of fatal overdose, reported as proportion of participants reporting fatal overdose

    Time frame: At 14, 48, and 90 days after jail release

  4. 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

    Time frame: At 14, 48, and 90 days after jail release

  5. 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

    Time frame: At 14, 48, and 90 days after jail release

  6. Ongoing engagement in SUD treatment

    Engagement in SUD treatment in the past 34 days, reported as proportion of participants reporting ongoing engagement

    Time frame: At 90 days after jail release

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Apr 2030, 42 months later.

Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 42 months is above that.

Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Nov 2, 2026
StartEst.
Oct 2026
Primary completionEst.
Apr 2030
CompletionEst.
Jun 2030
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911332
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2030 (estimated)
Completion
Jun 2030 (estimated)
Last update
Nov 2, 2026

Study contacts

Research Manager
Contact
jbjack@email.unc.edu
919-966-0551
Program Manager
Contact
creag@unc.edu
919-420-9257
Andrea K Knittel, MD PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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