Recruiting

Observational Study

Sponsor:

Michele Staton

Code:

NCT07179614

Conditions

Overdose Risk

Opioid Use Disorder

Stimulant Use Disorders

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Overdose Prevention Intervention Package (OPIP)

Study Details

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.

Conditions

Overdose Risk

Opioid Use Disorder

Stimulant Use Disorders

Study ID

NCT07179614

Start date

Jun 23, 2026

Status verified date

Aug, 2026

Completion date

Oct 30, 2030

Anticipated

Primary completion date

Oct 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Recovery Coaching Only

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.

experimental: Recovery Coaching + Safe Person Engagement

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.

experimental: Recovery Coaching + Contingency Management

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.

experimental: Recovery Coaching + Support Person Eng + Contingency Management

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.

Interventions

Overdose Prevention Intervention Package (OPIP)

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 outcome measure

  • Overdose risk [ Time Frame: 3, 6, and 12 months post-release ]
  • Treatment entry [ Time Frame: 1 month postrelease ]

Central Contacts and Locations

Central contacts

Locations

Harlan County Detention Center

Recruiting

Harlan, Kentucky, United States, 40828

Contacts

Derrick Moore Deputy Jailer

606-837-0096HarlanDep@ky.gov

Leslie County Detention Center

Recruiting

Hyden, Kentucky, United States, 41749

Contacts

More Information

Sponsor

Michele Staton

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Overdose
  • women
  • criminal justice
  • opioid use disorder
  • stimulant use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michele Staton on 2026-08-28.