NCT04069624

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 17, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5.4 years

First QC Date

August 23, 2019

Last Update Submit

March 12, 2026

Conditions

Opioid-use Disorder

Keywords

MOUDOUDTelehealthNavigator

Outcome Measures

Primary Outcomes (1)

  • The number of participants who initiate MOUD

    Any initiation of MOUD post-release over the study period

    13 months

Secondary Outcomes (6)

  • Medication Type

    13 months

  • Opioid Relapse

    13 months

  • Treatment Retention

    13 months

  • Recidivism

    12 months

  • Overdose Rates

    13 months

  • +1 more secondary outcomes

Other Outcomes (5)

  • Total Annual Intervention Cost

    5 years

  • Average Participant Cost

    13 months

  • Incremental Cost-Effectiveness Ratio

    5 years

  • +2 more other outcomes

Study Arms (3)

Services as Usual (SAU)

ACTIVE COMPARATOR

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

MOUD Pre-Treatment Telehealth

EXPERIMENTAL

Telehealth connection to a community MOUD provider.

Behavioral: MOUD Pre-Treatment Telehealth

MOUD Pre-Treatment Telehealth and Peer Navigator

EXPERIMENTAL

Telehealth connection to a community MOUD provider, in addition to a peer navigator

Behavioral: MOUD Pre-Treatment Telehealth and Peer Navigator

Interventions

MOUD Pre-Treatment TelehealthBEHAVIORAL

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
MOUD Pre-Treatment Telehealth and Peer NavigatorBEHAVIORAL

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.

MOUD Pre-Treatment Telehealth and Peer Navigator
Services as UsualOTHER

Medications to treat opioid use disorder (MOUD) pre-treatment.

Services as Usual (SAU)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hardin County Detention Center

Elizabethtown, Kentucky, 42701, United States

Location

Harlan County Detention Center

Harlan, Kentucky, 40828, United States

Location

Henderson County Detention Center

Henderson, Kentucky, 42420, United States

Location

Marion County Detention Center

Lebanon, Kentucky, 40033, United States

Location

Grayson County Detention Center

Leitchfield, Kentucky, 42754, United States

Location

Laurel County Correctional Center

London, Kentucky, 40741, United States

Location

Pike County Detention Center

Pikeville, Kentucky, 41501, United States

Location

Shelby County Detention Center

Shelbyville, Kentucky, 40065, United States

Location

Grant County Detention Center

Williamstown, Kentucky, 41097, United States

Location

Related Publications (1)

  • 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.

    PMID: 39367439DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Michele Staton, MSW, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

December 17, 2020

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data at this time.

Locations

US(9)