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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
W-JCOIN Trial 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.Check my eligibility
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.See study design
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.
W-JCOIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of participants who initiate MOUD
Secondary outcome measures
Criminal Activity
Medication Type
Opioid Relapse
+3 moreOther outcome measures
Average Participant Cost
Incremental Cost-Effectiveness Ratio
Public Health Cost of Opioid Relapse
+2 moreW-JCOIN 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.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,617,733 Total Patients Enrolled
Michele StatonLead Sponsor
3 Previous Clinical Trials
469 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)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must agree to participate in medication treatment before starting the study.You have used opioid drugs (prescription or street) frequently and have a high score on a screening test called ASSIST.I have difficulty with memory or thinking clearly.
Research Study Groups:
This trial has the following groups:- Group 1: MOUD Pre-Treatment Telehealth
- Group 2: Services as Usual (SAU)
- Group 3: MOUD Pre-Treatment Telehealth and Peer Navigator
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent are hospitals facilitating this investigation?
"8 particular sites are running this trial; the Grayson County Detention Center in Leitchfield, Marion County Detention Center in Lebanon, and Harlan County Detention Centre in Harlan being prominent examples. 5 other medical centres round out the selection of 8."
Answered by AI
Are new participants being sought to join this medical experiment?
"Affirmative, it appears that the trial is presently enlisting participants. First posted on December 17th 2020 with its most recent update occurring August 18th 2022, this clinical research necessitates 900 individuals from 8 separate medical centers."
Answered by AI
What is the enrollment number for this research project?
"Affirmative, the information on clinicaltrials.gov attests to this medical trial being actively recruiting participants with a commencement date of December 17th 2020 and latest update occurring in August 18th 2022. The study seeks 900 patients from 8 different locations."
Answered by AI
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