Kentucky Women's Justice Community Opioid Innovation Network
NCT ID: NCT04069624
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
900 participants
INTERVENTIONAL
2020-12-17
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Kentucky Women's Justice Community Overdose Innovation Network - Phase II
NCT07179614
Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)
NCT06857968
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
NCT06837662
NET Device for Treating Opioid Use Disorder
NCT04916600
Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention
NCT05973838
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Services as Usual (SAU)
Substance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.
Services as Usual
Medications to treat opioid use disorder (MOUD) pre-treatment.
MOUD Pre-Treatment Telehealth
Telehealth connection to a community MOUD provider.
MOUD Pre-Treatment Telehealth
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 Navigator
Telehealth connection to a community MOUD provider, in addition to a peer navigator
MOUD Pre-Treatment Telehealth and Peer Navigator
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MOUD Pre-Treatment Telehealth
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 Navigator
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 Usual
Medications to treat opioid use disorder (MOUD) pre-treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willingness to participate in MOUD pre-treatment
* Incarceration period of at least 7 days
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Michele Staton
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michele Staton
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michele Staton, MSW, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hardin County Detention Center
Elizabethtown, Kentucky, United States
Harlan County Detention Center
Harlan, Kentucky, United States
Henderson County Detention Center
Henderson, Kentucky, United States
Marion County Detention Center
Lebanon, Kentucky, United States
Grayson County Detention Center
Leitchfield, Kentucky, United States
Laurel County Correctional Center
London, Kentucky, United States
Pike County Detention Center
Pikeville, Kentucky, United States
Shelby County Detention Center
Shelbyville, Kentucky, United States
Grant County Detention Center
Williamstown, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
51656
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.