Recovery Management Checkups for Opioid Use Disorder
(JCOIN-HUB Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMichael L Dennis, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Chestnut Health Systems
Must be taking: MOUD
Disqualifiers: Under 18, Cognitive impairment, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The experiment will be conducted in collaboration with 6 jails representing discrete geographic counties in Illinois and the opioid treatment providers (OTP) that serve them. It will compare a re-entry as usual control group with two experimental groups in terms of their impact on the OUD service cascade, as well as public health and public safety outcomes. Study recruitment sites are six jails that provide treatment with medication for opioid use disorder (MOUD) to inmates with OUD prior to their release. At the time of their release to the community, 750 men and women will be randomly assigned to 1 of 3 groups: a) a re-entry as usual control, b) RMC with monthly checkups for 3 months post-release followed by quarterly checkups up to 2 years, or c) an adaptive version of RMC (RMC-A) that includes a modified checkup schedule based on each individual's pattern of treatment need. All participants will complete research interviews at release and quarterly thereafter up to 2 years post-enrollment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Recovery Management Checkups (RMC) for opioid use disorder?
Research shows that Recovery Management Checkups (RMC) are effective in linking patients to substance use disorder treatment and improving engagement in care, which can help reduce substance use.
12345How does the Recovery Management Checkups treatment differ from other treatments for opioid use disorder?
Recovery Management Checkups (RMC) are unique because they focus on regular follow-ups and early reintervention to help link patients to treatment and maintain engagement, rather than just providing initial treatment. This approach is particularly effective in primary care settings and for individuals recently released from jail, helping to reduce substance use and improve treatment outcomes.
12346Eligibility Criteria
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.Inclusion Criteria
Meets DSM-5 opioid use disorder criteria in the past year
Is released from 1 of the participating jails.
Reports heroin or other opioid use in the 90 days prior to entering jail
Exclusion Criteria
I am younger than 18 years old.
Resides outside the service area.
I am unable to understand and give consent due to cognitive issues.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-release
Participants receive treatment with medication for opioid use disorder (MOUD) while incarcerated
Varies
Re-entry and Initial Treatment
Participants are randomly assigned to one of three groups upon release: re-entry as usual, RMC, or RMC-Adaptive. Initial checkups and treatment linkage occur.
3 months
Monthly checkups
Ongoing Treatment and Checkups
Participants continue with quarterly checkups and treatment engagement, with adaptive checkup schedules for RMC-Adaptive group.
21 months
Quarterly checkups
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of opioid use, illegal activity, and quality of life.
24 months
Quarterly assessments
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Chestnut Health Systems-Lighthouse InstituteChicago, IL
Loading ...
Who Is Running the Clinical Trial?
Chestnut Health SystemsLead Sponsor
References
Results from two randomized clinical trials evaluating the impact of quarterly recovery management checkups with adult chronic substance users. [2023]Post-discharge monitoring and early reintervention have become standard practice when managing numerous chronic conditions. These two experiments tested the effectiveness of recovery management checkup (RMC) protocols for adult chronic substance users.
Using recovery management checkups for primary care to improve linkage to alcohol and other drug use treatment: a randomized controlled trial three month findings. [2023]Recovery management checkups (RMC) have established efficacy for linking patients to substance use disorder (SUD) treatment. This study tested whether using RMC in combination with screening, brief intervention, and referral to treatment (SBIRT), versus SBIRT alone, can improve linkage of primary care patients referred to SUD treatment.
A randomized controlled trial of recovery management checkups for primary care patients: Twelve-month results. [2023]Primary care settings like federally qualified health centers (FQHC) are optimal locations to identify individuals with substance use disorders (SUD) and link them to SUD treatment, yet successful linkage has proven difficult. Recovery management checkups for primary care (RMC-PC) is a promising method for increasing linkage to care, engagement in treatment, and reducing substance use.
The first 90 days following release from jail: findings from the Recovery Management Checkups for Women Offenders (RMCWO) experiment. [2021](1) To examine the impact of monthly Recovery Management Checkups (RMC) vs. control in the first 90 days post-release from jail on receipt of community-based substance abuse treatment, and (2) To explore the impact of RMC, treatment, and abstinence on HIV risk behaviors and recidivism.
Predictive Validity of Outpatient Follow-up After Detoxification as a Quality Measure. [2018]Care coordination for substance use disorder (SUD) treatment is a persistent challenge. Timely outpatient follow-up after detoxification from alcohol and opiates is associated with improved outcomes, leading some care systems to attempt to measure and incentivize this practice. This study evaluated the predictive validity of a 7-day outpatient follow-up after detoxification quality measure used by the Veterans Health Administration (VHA).
Predictors of resolution of aberrant drug behavior in chronic pain patients treated in a structured opioid risk management program. [2009]To identify demographic and clinical predictors of the resolution of aberrant drug-related behaviors (ADRBs) in a group of patients referred to the Opioid Renewal Clinic (ORC) by their primary care providers (PCPs). ORC is a program supporting PCPs' use of opioids for chronic pain in patients perceived as at risk for opioid abuse or those with demonstrated ADRBs.