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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- 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.
- 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.
- 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.
- Conditions
- Opioid-use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Services as Usual (SAU) | Active comparator | Substance 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 Telehealth | Experimental | Telehealth connection to a community MOUD provider. Receives: Behavioral: MOUD Pre-Treatment Telehealth |
| MOUD Pre-Treatment Telehealth and Peer Navigator | Experimental | Telehealth 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.
The number of participants who initiate MOUD
Any initiation of MOUD post-release over the study period
Measured: 13 months
Secondary outcomes (6)
Medication Type
Percentage of participants on naltrexone, buprenorphine or methadone.
Measured: 13 months
Opioid Relapse
Percentage of participants relapsing, measured by self-report or drug screen.
Measured: 13 months
Treatment Retention
Length of time in treatment
Measured: 13 months
Recidivism
Percent of participants returning to custody
Measured: 12 months
Overdose Rates
Percentage of participants who overdose (medical attention needed for revival)
Measured: 13 months
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.
- First posted28 Aug 2019
- Study start17 Dec 2020
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele Staton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Michele Staton, University of Kentucky
- Investigators
- Michele Staton, MSW, PhD, Principal investigator, University of Kentucky
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 42568290Staton 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kentucky Women's Justice Community Opioid Innovation Network
- ClinicalTrials.gov ID
- NCT04069624
- Acronym / sponsor ID
- W-JCOIN / 51656
- Conditions
- Opioid-use Disorder
- Keywords
- MOUD, OUD, Telehealth, Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Michele StatonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 28 Aug 2019 (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 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.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Services as Usual (SAU) | Active comparator | Other: Services as UsualSubstance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release. |
| MOUD Pre-Treatment Telehealth | Experimental | Behavioral: MOUD Pre-Treatment TelehealthTelehealth connection to a community MOUD provider. |
| MOUD Pre-Treatment Telehealth and Peer Navigator | Experimental | Behavioral: MOUD Pre-Treatment Telehealth and Peer NavigatorTelehealth connection to a community MOUD provider, in addition to a peer navigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASSIST opioid (prescription or street) score of 4+
- Willingness to participate in MOUD pre-treatment
- Incarceration period of at least 7 days
Key exclusion criteria (1 listed)
- Cognitive impairment
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 |
|---|---|---|
| MOUD Pre-Treatment TelehealthOpioid use disorder (OUD) assessment, medical evaluation, and medications to treat opioid use disorder (MOUD) education with a MOUD provider during incarceration via telehealth | Behavioural | MOUD Pre-Treatment Telehealth |
| MOUD Pre-Treatment Telehealth and Peer NavigatorOpioid 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. | Behavioural | MOUD Pre-Treatment Telehealth and Peer Navigator |
| Services as UsualMedications to treat opioid use disorder (MOUD) pre-treatment. | Other | Services as Usual (SAU) |
Primary outcome
The number of participants who initiate MOUD
Time frame: 13 months
Any initiation of MOUD post-release over the study period
6 secondary outcomes
Medication Type
Time frame: 13 months
Opioid Relapse
Time frame: 13 months
Treatment Retention
Time frame: 13 months
Recidivism
Time frame: 12 months
Overdose Rates
Time frame: 13 months
Criminal Activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 42568290Dickson 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.
- Derived from this study: PubMed 39367439Staton 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data at this time.
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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. This study is not recruiting at the moment.
Michele Staton, MSW, PhD principal investigator
University of Kentucky
9 sites in 1 country: see every site and its status.
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.