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Opioid-use DisorderW-JCOINNCT04069624

Kentucky Women's Justice Community Opioid Innovation Network

A study testing MOUD Pre-Treatment Telehealth, MOUD Pre-Treatment Telehealth and Peer Navigator and Services as Usual in people with Opioid-use Disorder, run by Michele Staton at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial will test the effectiveness of delivering medication for opioid use disorder (MOUD) pre-treatment via telehealth, alone and with peer navigation, to increase MOUD initiation and maintenance in the community following jail release. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Opioid-use Disorder
What is being tested?
MOUD Pre-Treatment Telehealth, MOUD Pre-Treatment Telehealth and Peer Navigator and Services as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
9 sitesUnited States
Study dates
17 Dec 2020to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ASSIST opioid (prescription or street) score of 4+
  • Willingness to participate in MOUD pre-treatment
  • Incarceration period of at least 7 days

Who cannot join

  • Cognitive impairment

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites
  • Hardin County Detention Center

    Elizabethtown, Kentucky, 42701

  • Harlan County Detention Center

    Harlan, Kentucky, 40828

  • Henderson County Detention Center

    Henderson, Kentucky, 42420

  • Marion County Detention Center

    Lebanon, Kentucky, 40033

  • Grayson County Detention Center

    Leitchfield, Kentucky, 42754

  • Laurel County Correctional Center

    London, Kentucky, 40741

  • Pike County Detention Center

    Pikeville, Kentucky, 41501

  • Shelby County Detention Center

    Shelbyville, Kentucky, 40065

  • Grant County Detention Center

    Williamstown, Kentucky, 41097

Other trials in United States

About this study

This trial will test the effectiveness of delivering medication for opioid use disorder (MOUD) pre-treatment via telehealth, alone and with peer navigation, to increase MOUD initiation and maintenance in the community following jail release. This trial will focus on incarcerated women in 6 experimental and 3 control sites in Kentucky. Enrollment is not open to the general public.

Read the detailed description

This study will incorporate random assignment for two study conditions: medication for opioid use disorder (MOUD) PreTreatment Telehealth or MOUD PreTreatment Telehealth with Peer Navigation using a rigorous randomized block design. Women in the experimental conditions will be stratified by sites (6 sites; 3 urban and 3 non-urban) and by offender classification level of felony versus misdemeanor (due to potential differences in community supervision). Three comparison sites with existing jail-based MOUD treatment for women will not be randomized but will be included in analyses within planned, non-randomized comparisons.

  1. MOUD PreTreatment Telehealth: Participants who screen positive for moderate to high-risk opioid use and complete the baseline interview will be connected via telehealth to the community MOUD provider for a psychosocial assessment. The study data coordinator will assist with linking the participant to the community MOUD provider via telehealth, as well as collecting initial in-person biological specimens for medical evaluation. The psychosocial assessment with the community MOUD provider will involve a more detailed examination of OUD using the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria. Type of medication (naltrexone, buprenorphine, or methadone) will depend on the psychosocial assessment and medical evaluation. Indications for the most appropriate course of treatment will be determined by the community MOUD provider in conjunction with the study participant. Women in this condition will also receive general education about MOUD options including risks and benefits, and they will be given the opportunity to ask questions about the medication. The community MOUD provider will also use motivational interviewing to assess each woman's readiness to engage in MOUD and to better understand possible barriers to MOUD utilization. At the end of the education session, the study participant and the MOUD community provider will develop a re-entry plan for ongoing care, which will include a plan for insurance coverage of medications in the community.
  2. MOUD PreTreatment Telehealth + Peer Navigation: In addition to MOUD PreTreatment Telehealth, women in this arm will be connected with a peer, a woman in recovery who is employed by Voices of Hope (VOH) in Lexington, KY. Peer Navigators will be located in Lexington through a partnership with VOH. VOH is a non-profit recovery support organization which provides peer recovery support services. In conjunction with the study data coordinators, the Peer Navigator will schedule an initial session via telehealth with the participant, assist with scheduling a follow-up appointment with the community MOUD provider, and provide recovery support for community MOUD initiation and maintenance. Peer Navigators will be certified Peer Support Specialists trained and supervised by VOH in accordance with state statutory requirements. When a woman returns to the community, Peer Navigators will engage her in weekly telephone recovery services (TRS) for 12 weeks, which may include identifying personal goals and strength-based, practical strategies for success. In addition to MOUD linkages to care, Peer Navigators will suggest strategies to maintain sobriety and improve recovery capital, including safe housing, transportation, financial counseling, continued education, employment skills, and sober social activities.
  3. Services as Usual: Women in this arm will not be randomized, but will receive substance abuse treatment as usual in three comparison jail sites. Each of these jails has a women's substance abuse program (SAP) managed by the Kentucky Department of Corrections (KY-DOC with the option to initiate MOUD prior to jail release. These programs operate as modified therapeutic communities with transitional support following release.
Being tested
MOUD Pre-Treatment Telehealth, MOUD Pre-Treatment Telehealth and Peer Navigator, Services as Usual
Keywords
MOUD, OUD, Telehealth, Navigator
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOUD Pre-Treatment TelehealthBehavioural

    Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth

  • MOUD Pre-Treatment Telehealth and Peer NavigatorBehavioural

    Opioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth. Additionally, participants will be connected with a Peer Navigator who will meet with them via telehealth prior to release and provide ongoing support by telephone post-release.

  • Services as UsualOther

    Medications to treat opioid use disorder (MOUD) pre-treatment.

Study groups in NCT04069624
Study groupRoleWhat they receive
Services as Usual (SAU)Active comparatorSubstance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.
Receives: Other: Services as Usual
MOUD Pre-Treatment TelehealthExperimentalTelehealth connection to a community MOUD provider.
Receives: Behavioral: MOUD Pre-Treatment Telehealth
MOUD Pre-Treatment Telehealth and Peer NavigatorExperimentalTelehealth connection to a community MOUD provider, in addition to a peer navigator
Receives: Behavioral: MOUD Pre-Treatment Telehealth and Peer Navigator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants who initiate MOUD

    Any initiation of MOUD post-release over the study period

    Measured: 13 months

Secondary outcomes (6)
  1. Medication Type

    Percentage of participants on naltrexone, buprenorphine or methadone.

    Measured: 13 months

  2. Opioid Relapse

    Percentage of participants relapsing, measured by self-report or drug screen.

    Measured: 13 months

  3. Treatment Retention

    Length of time in treatment

    Measured: 13 months

  4. Recidivism

    Percent of participants returning to custody

    Measured: 12 months

  5. Overdose Rates

    Percentage of participants who overdose (medical attention needed for revival)

    Measured: 13 months

  6. Criminal Activity

    Percent of participants engaging in criminal activity (self-report or arrest records)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start17 Dec 2020
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

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
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04069624
Sponsor's protocol ID
51656
Other IDs
1UG1DA050069
Acronym
W-JCOIN
Status last verified
May 2026
First submitted
23 Aug 2019
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data at this time.

Publications

  • Dickson MF, Monticello K, Pike E, Webster JM, Staton M. Correlates of Post-Release Overdose Among Women With Opioid Use Disorder Returning to the Community Following Jail Incarceration. Subst Use Addctn J. 2026 Aug 7:29767342261468432. doi: 10.1177/29767342261468432. Online ahead of print.

    PubMed 42568290
  • Staton M, Levi M, Winston E, B Oser C, Fallin-Bennett A, Dickson M, Matthew Webster J, Leukefeld C, Tillson M. Examining use of telehealth in jails: linking women to community OUD services. BMC Womens Health. 2024 Oct 4;24(1):549. doi: 10.1186/s12905-024-03394-4.

    PubMed 39367439

Questions about this trial

What is this clinical trial studying?

A study testing MOUD Pre-Treatment Telehealth, MOUD Pre-Treatment Telehealth and Peer Navigator and Services as Usual in people with Opioid-use Disorder, run by Michele Staton at 9 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 3 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants who initiate MOUD (time frame: 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069624, which also lists 2 linked publications.

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 18 May 2026.

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