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MOUD Pre-Treatment + Telehealth for Opioid Use Disorder (W-JCOIN Trial)

N/A
Waitlist Available
Led By Michele Staton, MSW, PhD
Research Sponsored by Michele Staton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of delivering medication for opioid use disorder (MOUD) pre-treatment via telehealth, with and without peer navigation, to increase MOUD initiation and maintenance in the community following jail release.

Who is the study for?
This trial is for incarcerated women in Kentucky who have been jailed for at least a week, show significant opioid use with an ASSIST score of 4 or more, and are willing to start treatment for opioid addiction. It's not open to the public and excludes those with cognitive impairments.
What is being tested?
The study tests if telehealth services before release from jail can help women start and stick with medication treatments for opioid addiction. Some will also get support from peers who've had similar experiences, while others receive usual care without these additions.
What are the potential side effects?
Since this trial focuses on service delivery methods rather than new medications, side effects relate mainly to potential technical issues or privacy concerns with telehealth, as well as emotional impacts of peer navigation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have difficulty with memory or thinking clearly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of participants who initiate MOUD
Secondary study objectives
Criminal Activity
Medication Type
Opioid Relapse
+3 more
Other study objectives
Average Participant Cost
Incremental Cost-Effectiveness Ratio
Public Health Cost of Opioid Relapse
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MOUD Pre-Treatment Telehealth and Peer NavigatorExperimental Treatment1 Intervention
Telehealth connection to a community MOUD provider, in addition to a peer navigator
Group II: MOUD Pre-Treatment TelehealthExperimental Treatment1 Intervention
Telehealth connection to a community MOUD provider.
Group III: Services as Usual (SAU)Active Control1 Intervention
Substance abuse program (SAP) managed by the Kentucky Department of Corrections, with the option to initiate MOUD prior to jail release.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,035 Total Patients Enrolled
Michele StatonLead Sponsor
4 Previous Clinical Trials
733 Total Patients Enrolled
Michele Staton, MSW, PhDPrincipal Investigator - University of Kentucky
Michele D Staton MD PLLC
Marshall University School Of Medicine (Medical School)
University Of Ky A B Chandler (Residency)
1 Previous Clinical Trials
264 Total Patients Enrolled

Media Library

MOUD Pre-Treatment Telehealth (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04069624 — N/A
Opioid Use Disorder Research Study Groups: MOUD Pre-Treatment Telehealth, Services as Usual (SAU), MOUD Pre-Treatment Telehealth and Peer Navigator
Opioid Use Disorder Clinical Trial 2023: MOUD Pre-Treatment Telehealth Highlights & Side Effects. Trial Name: NCT04069624 — N/A
MOUD Pre-Treatment Telehealth (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069624 — N/A
~69 spots leftby Apr 2025
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