← Back to Search

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

Must not have

Is under age 18

Has cognitive impairment that precludes ability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am younger than 18 years old.

Select...

I am unable to understand and give consent due to cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Months of treatment with medication for opioid use disorder (MOUD)

Secondary study objectives

Costs-of-Crime

Costs-of-Healthcare-Utilization

Days of Opioid Use

+6 more

Awards & Highlights

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.

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

0 / 2Eligibility criteria met