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NCT Number: NCT07179614

Kentucky Women's Justice Community Overdose Innovation Network - Phase II

This project continues our work with women in the Kentucky Women's Justice Community Overdose Innovation Network Phase II (WJCOIN-II) with the overall aim of reducing overdose risk during the transition from jail to rural communities. WJCOIN-II has potential for significant impact regarding the effectiveness, implementation, and sustainability of innovative overdose prevention strategies during the high-risk time of community re-entry among vulnerable, CLS-involved women in rural communities. This research will impact the field by increasing the capacity of the criminal legal system to respond to the overdose crisis through increased access to prevention strategies to reduce overdose risk.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harlan County Detention Center

Harlan, Kentucky, 40828, United States

Location status: Recruiting

Location contact

Derrick Moore Deputy Jailer

CONTACT

[email protected]

606-837-0096

About this study

Overdose deaths among women rose nearly 500% in the past two decades, a rate considerably higher than men. Yet, overdose prevention approaches that target the unique risks of women, particularly those involved in the criminal legal system (CLS) in underserved rural areas, are limited. This application proposes to continue our work with women in the Kentucky Women's Justice Community Overdose Innovation Network Phase II (WJCOIN-II) with the overall aim of reducing overdose risk during the transition from jail to rural communities. Specific aims include: Aim 1: Compare the effectiveness of pre-release RC to RC+SPE in decreasing women's overdose risk during re-entry to rural communities. Through a multi-site 2 X 2 factorial design, women will be randomly assigned to two pre-release conditions (1) Recovery Coaching (RC) only or (2) RC + support person engagement (SPE) to reduce overdose risk through the development of an overdose prevention plan and increase motivation for treatment entry within one-month post-release. Aim 2: Compare the additive effectiveness of CM initiated post-release to RC alone and RC+SPE in decreasing overdose risk and increasing treatment entry and retention among women during re-entry to rural communities. The 2 X 2 factorial randomized design also includes assignment to one of two post-release conditions: 1) continuation of pre-release intervention (RC or RC+SPE) only in the community through ongoing sessions, or 2) addition of contingency management (RC+CM or RC+SPE+CM) to incentivize target behaviors (reduced days of drug use). Depending on treatment entry by the one-month post-release period (non-initiators vs. initiators of treatment), the following aims will be examined post-release from jail: Aim 2a. Among non-initiators, examine the additive effectiveness of post-release CM to reduce overdose risk. Aim 2b. Among treatment initiators, examine the additive effectiveness of post-release CM to increase treatment retention. Aim 3: Contextualize effectiveness of intervention components by examining the roles of perceived acceptability and appropriateness, and identify barriers and facilitators to intervention implementation across the re-entry continuum. Acceptability and appropriateness of intervention components from the perspectives of women and public safety/public health stakeholders (e.g., jail staff, RCs, treatment providers) will be measured through individual-level survey data collection. Aim 4: Examine economic impact of the WJCOIN-II interventions pre-release and post-release in reducing women's overdose risk in rural communities. Cost effectiveness and net societal costs will be assessed by incorporating clinical (overdose risk) and service utilization (treatment entry) outcomes using tailored budget impact tools. The study will make a significant impact regarding the effectiveness, implementation, and sustainability of innovative overdose prevention strategies during the high-risk time of community re-entry among vulnerable, CLS-involved women in rural communities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-5 scores of 2+ for opioids (OUD) and/or stimulants (StUD),
  • no evidence of cognitive impairment in providing consent,
  • a release date within 7-60 days to allow for time for intervention sessions,
  • willingness to consider SUD treatment post-release, and
  • willingness to provide the name and contact information of at least one person in the community who will support the woman's recovery pre/post-release (SP).

Exclusion criteria

  • Not living in a rural area
  • Any condition that would not allow capable informed consent

Treatment and study plan

Overdose Prevention Intervention Package (OPIP)

Behavioral

WJCOIN-II's multi-level 2 X 2 randomized factorial design will examine the effectiveness of OPIP components across four study conditions randomly assigned after baseline data collection (n=75 per condition, 100 per jail site), summarized in Table 7 and described below. In addition to group assignment, outcomes will be assessed as a function of engagement in each intervention component defined as the number of sessions attended (RC and CM conditions) and perceived support, which is a count of the number of types of support provided by the RC and SP (e.g., emotional, financial, etc.).

Primary outcomes

  1. Overdose risk

    Time frame: 3, 6, and 12 months post-release

    Overdose risk score based on days of opioid, stimulant, and polysubstance use

  2. Treatment entry

    Time frame: 1 month postrelease

    Entry into any formal ASAM level of SUD treatment (e.g., outpatient, intensive outpatient, residential, inpatient, MOUD) (yes/no)

Study contacts

Contact information is provided by the study sponsor or research team.

Martha Tillson, PhD

CONTACT

[email protected]

859-447-5007

Michele Staton, PhD

CONTACT

[email protected]

859-312-8245

Sponsors and collaborators

Lead sponsor

Michele Staton

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: WJCOIN-II

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 18, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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