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Recovery Management Checkups for Opioid Use Disorder (JCOIN-HUB Trial)
Phase 3
Recruiting
Led By Michael L Dennis, PhD
Research Sponsored by Chestnut Health Systems
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 24 months
Awards & highlights
JCOIN-HUB Trial Summary
This trial will compare the outcomes of people with opioid use disorder who are released from jail under different conditions.
Who is the study for?
This trial is for adults who have used opioids in the last 90 days, are being released from one of six participating jails in Illinois, and meet criteria for opioid use disorder. It's not open to those under 18 or with cognitive impairments that prevent informed consent, or if they live outside the service area.Check my eligibility
What is being tested?
The study compares usual re-entry support against two experimental groups: one receiving monthly Recovery Management Checkups (RMC) for three months then quarterly up to two years; another getting an adaptive RMC based on individual treatment needs post-release.See study design
What are the potential side effects?
Since this trial focuses on checkup interventions rather than medications, it does not list specific side effects like drug trials do. However, participants may experience stress or discomfort during assessments.
JCOIN-HUB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Months of treatment with medication for opioid use disorder (MOUD)
Secondary outcome measures
Costs-of-Crime
Costs-of-Healthcare-Utilization
Days of Opioid Use
+6 moreJCOIN-HUB Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Recovery Management Checkups (RMC)Experimental Treatment1 Intervention
In the RMC condition, participants will have access to services provided as a part of re-entry as usual. In addition, checkups will be provided on a fixed schedule that includes face-to-face monthly checkups for the initial 3 months, and quarterly for the rest of the two years. Participants will have access to referrals and services provided by the jail and linkage to an OTP as part of their usual re-entry procedures. Individuals will meet with a Linkage Manager (LM) upon study enrollment and during each quarterly checkup, during which they will complete a Brief Treatment Needs Assessment, receive motivational interviewing, linkage assistance, or a check-in on continuing care and recovery support. The priority is to engage the individual into treatment with MOUD as soon as possible at the time of release, however, if individuals express a preference for another form of SUD treatment, the LM will work with that individual to link, engage, and retain them in that form of treatment.
Group II: RMC-AdaptiveExperimental Treatment1 Intervention
In the RMC-Adaptive condition, checkups will be provided based on the participant's current need for treatment and will be adapted in three ways. First, the interval between RMC-A check-ups will vary (in 1-month increments) depending upon the individual's assessed need for treatment at the prior check-up. Second, in cases where participants have 3 consecutive checkups in which they need treatment, the LM and treatment provider will discuss how to better meet the participant's needs, e.g., a different treatment provider, different type of MOUD or other types of treatment, and/or additional services. Third, if RMC-A participants are re-incarcerated at the time of their checkup, the LM will meet with the individual while incarcerated to discuss a recovery plan, which may include initiation of treatment with MOUD while incarcerated and re-linkage to an OTP upon release.
Group III: Re-Entry as UsualActive Control1 Intervention
The type and level of services provided to individuals at re-entry will vary across jails and will be carefully documented. For the most part, individuals released to the community will receive a referral to an opioid treatment provider (OTP) for treatment with MOUD, and a subset may potentially be mandated to participate in community based treatment and/or recovery programs such as recovery coaching, and/or sentenced to varying levels of probation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recovery Management Checkups (RMC)
2004
Completed Phase 3
~450
Find a Location
Who is running the clinical trial?
Chestnut Health SystemsLead Sponsor
21 Previous Clinical Trials
22,615 Total Patients Enrolled
Michael L Dennis, PhDPrincipal InvestigatorChestnut Health Systems
Christy K Scott, PhDPrincipal InvestigatorChestnut Health Systems
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 years old.I am unable to understand and give consent due to cognitive issues.
Research Study Groups:
This trial has the following groups:- Group 1: Recovery Management Checkups (RMC)
- Group 2: RMC-Adaptive
- Group 3: Re-Entry as Usual
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Are there any unfilled vacancies for participants in this experiment?
"Yes, this information is available on clinicaltrials.gov. The posting for the trial went up on 4/1/2021 and was updated as recently as 3/7/2022."
Answered by AI
What does the FDA have to say about Recovery Management Checkups?
"There is both supportive efficacy data and extensive safety data available for Recovery Management Checkups (RMCs), so it received a score of 3."
Answered by AI
How many individuals are taking part in this research project?
"That is correct. The online clinicaltrial database has the most recent information about this trial, which was last updated on March 7th, 2022. They are looking for 750 people to participate at 1 location."
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