NCT07179614

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
54mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

May 18, 2026

Expected
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2030

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

September 16, 2025

Last Update Submit

April 20, 2026

Conditions

Keywords

Overdosewomencriminal justiceopioid use disorderstimulant use disorder

Outcome Measures

Primary Outcomes (2)

  • Overdose risk

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

    3, 6, and 12 months post-release

  • Treatment entry

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

    1 month postrelease

Study Arms (4)

Recovery Coaching Only

EXPERIMENTAL

Following the clinical assessment, all participants will receive the "base" recovery coaching intervention pre-release. RCs will be employed by VOH and will be women with lived experience with OUD/StUD recovery and CLS involvement who will provide strengths-based, person-centered recovery coaching sessions designed to reduce overdose risk. Women will meet with the RC pre-release to assess basic re-entry needs associated with entering treatment (e.g., lack of housing, food, clothing, transportation, employment). RCs will have access to a "barrier relief fund" to address these needs (e.g., clothes for an interview, transportation vouchers) following established RC protocols. At discharge, all women will be provided re-entry transition kits (e.g., hygiene items, condoms, overdose prevention resources) and naloxone.

Behavioral: Overdose Prevention Intervention Package (OPIP)

Recovery Coaching + Safe Person Engagement

EXPERIMENTAL

Women in this condition will receive the base (RC) pre-release intervention and the Support Person Engagement (SPE) component pre- and post-release. Support Person (SP) designation will draw upon 1) the woman's suggested SP at screening, 2) baseline social network data, and 3) the initial RC meeting. Identified SPs will be screened for eligibility, including being over the age of 18 and willing to engage in intervention sessions. Exclusion criteria for SPs (based on participant and SP self-report) includes past felony conviction, currently incarcerated, on community supervision, or prior history of domestic violence/EPOs. All SPE sessions will align with overdose risk education, understanding treatment options (including MOUD), naloxone distribution, and harm reduction strategies to keep the woman safe during community re-entry. SPs will have access to free naloxone to carry and distribute.

Behavioral: Overdose Prevention Intervention Package (OPIP)

Recovery Coaching + Contingency Management

EXPERIMENTAL

Women randomized to this group will receive the base pre-release RC intervention, 12 weeks of RC meetings post-release, and 12 weeks of CM post-release. Women will be informed before jail release of the expectations in the CM protocol, target behaviors, and incentive opportunities. The WJCOIN-II CM protocol will be an adapted version of Petry and Martin's approach to reinforce three target verifiable behaviors: 1) meeting with the RC; 2) stimulant abstinence; and 3) opioid abstinence using saliva drug screens. At the conclusion of weekly post-release RC sessions, research staff will join the video call for CM. Virtual CM is feasible, acceptable, and comparable to in-person CM, and research staff will administer CM separately to maintain the integrity of the RC/participant rapport. If the participant does not meet with their RC by the last day of a given week, research staff will contact the participant separately for a CM session.

Behavioral: Overdose Prevention Intervention Package (OPIP)

Recovery Coaching + Support Person Eng + Contingency Management

EXPERIMENTAL

Women in this intervention condition will participate in the RC condition (pre- and post-release), the SPE sessions (pre- and post-release), and CM post-release.

Behavioral: Overdose Prevention Intervention Package (OPIP)

Interventions

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.).

Recovery Coaching + Contingency ManagementRecovery Coaching + Safe Person EngagementRecovery Coaching + Support Person Eng + Contingency ManagementRecovery Coaching Only

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Links

MeSH Terms

Conditions

Opioid-Related DisordersDrug Overdose

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPrescription Drug MisuseDrug Misuse

Study Officials

  • Michele Staton, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Staton, PhD

CONTACT

Martha Tillson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 2X2 factorial design includes two levels of pre-release interventions (recovery coaching alone vs. adding support person engagement) and two levels of post-release interventions (prerelease condition alone vs. adding contingency management).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 18, 2025

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

October 30, 2030

Study Completion (Estimated)

October 30, 2030

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Pending approval by the IRB and NIDA cooperative

Locations