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Kentucky Women's Justice Community Opioid Innovation Network (W-JCOIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069624
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michele Staton, University of Kentucky

Study Description
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Brief 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. This trial will focus on incarcerated women in 6 experimental and 3 control sites in Kentucky. Enrollment is not open to the general public.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: MOUD Pre-Treatment Telehealth Behavioral: MOUD Pre-Treatment Telehealth and Peer Navigator Other: Services as Usual Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kentucky Women's Justice Community Opioid Innovation Network
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Other: Services as Usual
Medications to treat opioid use disorder (MOUD) pre-treatment.
Experimental: MOUD Pre-Treatment Telehealth
Telehealth connection to a community MOUD provider.
 Behavioral: 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
Experimental: MOUD Pre-Treatment Telehealth and Peer Navigator
Telehealth connection to a community MOUD provider, in addition to a peer navigator
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. The number of participants who initiate MOUD [ Time Frame: 13 months ]
    Any initiation of MOUD post-release over the study period


Secondary Outcome Measures :
  1. Medication Type [ Time Frame: 13 months ]
    Percentage of participants on naltrexone, buprenorphine or methadone.

  2. Opioid Relapse [ Time Frame: 13 months ]
    Percentage of participants relapsing, measured by self-report or drug screen.

  3. Treatment Retention [ Time Frame: 13 months ]
    Length of time in treatment

  4. Recidivism [ Time Frame: 12 months ]
    Percent of participants returning to custody

  5. Overdose Rates [ Time Frame: 13 months ]
    Percentage of participants who overdose (medical attention needed for revival)

  6. Criminal Activity [ Time Frame: 12 months ]
    Percent of participants engaging in criminal activity (self-report or arrest records)


Other Outcome Measures:
  1. Total Annual Intervention Cost [ Time Frame: 5 years ]
    Total annual intervention cost

  2. Average Participant Cost [ Time Frame: 13 months ]
    Average intervention cost per participant

  3. Incremental Cost-Effectiveness Ratio [ Time Frame: 5 years ]
    Cost per unit outcome of interventions versus services as usual

  4. Public Health Cost of Opioid Relapse [ Time Frame: 5 years ]
    Cumulative estimated cost of hospitalizations, treatments, loss of work, child welfare, and other services related to relapse.

  5. Public Safety Cost of Recidivism and Criminal Activity [ Time Frame: 5 years ]
    Cumulative estimated cost of return to custody, arrests, and other social costs of recidivism.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria

• Cognitive impairment

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069624


Contacts
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Contact: Michele Staton, MSW, PhD 859-257-2483 mstaton@uky.edu
Contact: Erin Winston, MPA 859-257-1720 ermcne0@uky.edu

Locations
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United States, Kentucky
Hardin County Detention Center Recruiting
Elizabethtown, Kentucky, United States, 42701
Contact: Cheryl Shook         
Harlan County Detention Center Recruiting
Harlan, Kentucky, United States, 40828
Contact: Derrick Moore         
Marion County Detention Center Recruiting
Lebanon, Kentucky, United States, 40033
Contact: Maggie Lockard         
Grayson County Detention Center Recruiting
Leitchfield, Kentucky, United States, 42754
Contact: Cyndi Lively         
Laurel County Correctional Center Recruiting
London, Kentucky, United States, 40741
Contact: Shawn Davis         
Pike County Detention Center Recruiting
Pikeville, Kentucky, United States, 41501
Contact: Ronald Sammons         
Shelby County Detention Center Recruiting
Shelbyville, Kentucky, United States, 40065
Contact: Kelsey Torres         
Grant County Detention Center Recruiting
Williamstown, Kentucky, United States, 41097
Contact: Penny Stacy         
Sponsors and Collaborators
Michele Staton
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Michele Staton, MSW, PhD University of Kentucky
More Information
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Responsible Party: Michele Staton, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04069624    
Other Study ID Numbers: 51656
1UG1DA050069-01 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michele Staton, University of Kentucky:
MOUD
OUD
Telehealth
Navigator
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders