Recovery Management Checkups for Opioid Use Disorder

(JCOIN-HUB Trial)

Overseen By Christine E Grella, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Chestnut Health Systems

Must be taking: MOUD

Disqualifiers: Under 18, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new strategies to support individuals with opioid use disorder (OUD) as they leave jail. Researchers aim to assess how different follow-up plans affect health and safety post-release. Participants will be divided into three groups: one receiving usual re-entry help, another with scheduled checkups (Recovery Management Checkups), and a third with flexible checkups tailored to their needs (RMC-Adaptive). The trial seeks individuals who have recently used opioids and are being released from specific jails. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Recovery Management Checkups (RMC) and its adaptive version, RMC-Adaptive, have been thoroughly studied. These checkups have demonstrated promising results in helping individuals with opioid use disorder (OUD) adhere to their treatment plans.

Regarding safety, studies did not identify any major safety concerns with either RMC or RMC-Adaptive, indicating that both treatments are generally well-tolerated by participants. The purpose of these checkups is to provide ongoing support and facilitate continued treatment. They do not involve new medications or invasive procedures, which often carry higher risks.

Both RMC and RMC-Adaptive aim to help participants maintain their treatment and progress toward recovery. This approach focuses on providing consistent support and guidance, and studies have not associated it with any serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Recovery Management Checkups (RMC) and RMC-Adaptive treatments for opioid use disorder because they offer a personalized approach to managing recovery. Unlike traditional treatments that often follow a one-size-fits-all schedule, RMC-Adaptive adjusts the frequency of checkups based on the individual's needs, ensuring timely intervention. This adaptability allows for better alignment with the participant's recovery journey, potentially leading to improved outcomes. Additionally, these methods emphasize ongoing support, including motivational interviewing and linkage to opioid treatment programs, helping individuals stay engaged and supported throughout their recovery.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that Recovery Management Checkups (RMC), one of the treatment arms in this trial, can significantly improve treatment outcomes for people with opioid use disorder (OUD). Studies have found that RMC leads to better long-term results compared to merely monitoring individuals. For example, early research indicated that treatment initiation rates increased from 5% to over 50% for those receiving RMC. Another treatment arm in this trial, the RMC-Adaptive (RMC-A) version, customizes checkups to fit each person's needs, helping them stay engaged in treatment. This personalized approach provides tailored support, aiding individuals in remaining in treatment and reducing the chance of relapse. Overall, both RMC and RMC-A show promise in effectively supporting people with OUD. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael L Dennis, PhD

Principal Investigator

Chestnut Health Systems

Are You a Good Fit for This Trial?

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

Resides outside the service area.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Recovery Management Checkups (RMC)
• RMC-Adaptive

Trial Overview 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.

How Is the Trial Designed?

Group I: Recovery Management Checkups (RMC) Experimental Treatment 1 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-Adaptive Experimental Treatment 1 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 Usual Active Control 1 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.

Who Is Running the Clinical Trial?

Chestnut Health Systems

Lead Sponsor

Trials

27

Recruited

24,500+

Published Research Related to This Trial

In a study of 266 primary care patients referred for substance use disorder treatment, those who received Recovery Management Checkups (RMC) alongside Screening, Brief Intervention, and Referral to Treatment (SBIRT) had significantly higher odds of engaging in any SUD treatment (46% vs 20%).

Patients receiving the combined RMC and SBIRT intervention reported more days in treatment, increased days of abstinence, and fewer days of substance use, indicating that RMC effectively enhances treatment linkage and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using recovery management checkups for primary care to improve linkage to alcohol and other drug use treatment: a randomized controlled trial three month findings. Scott, CK., Dennis, ML., Grella, CE., et al.[2023]

Women offenders who participated in monthly Recovery Management Checkups (RMC) were significantly more likely to engage in substance abuse treatment within the first 90 days post-release from jail compared to those in the control group.

Receiving treatment was associated with higher rates of abstinence from drugs and alcohol, which in turn led to reduced HIV risk behaviors and lower rates of recidivism among the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first 90 days following release from jail: findings from the Recovery Management Checkups for Women Offenders (RMCWO) experiment. Scott, CK., Dennis, ML.[2021]

In a study of 195 patients referred to the Opioid Renewal Clinic, 45.6% resolved their aberrant drug-related behaviors (ADRBs) within one year, indicating that a significant portion of patients can successfully manage their behaviors with appropriate support.

Patients with a history of cocaine abuse were five times more likely to fail the program, while having multiple pain diagnoses and being married were associated with better outcomes, suggesting that social support and the complexity of pain may influence treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of resolution of aberrant drug behavior in chronic pain patients treated in a structured opioid risk management program. Meghani, SH., Wiedemer, NL., Becker, WC., et al.[2009]

A study of 25,354 patients in the Veterans Health Administration found that receiving an outpatient follow-up visit within 7 days after detoxification from alcohol or opiates significantly increased subsequent outpatient treatment visits and inpatient admissions for substance use disorder and mental health conditions.

Meeting the 7-day follow-up quality measure was associated with a remarkable 53.3% reduction in the odds of 2-year mortality, highlighting the importance of timely care coordination in improving long-term outcomes for patients recovering from substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Validity of Outpatient Follow-up After Detoxification as a Quality Measure. Schmidt, EM., Gupta, S., Bowe, T., et al.[2018]

The Recovery Management Checkup (RMC) protocol, which includes quarterly monitoring and motivational interviewing, significantly improved outcomes for adults with chronic substance dependence compared to a control group over a 2-year period.

Participants in the RMC group experienced greater reductions in substance use, fewer days until readmission, and increased days of abstinence, with effect sizes indicating stronger benefits in the second experiment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from two randomized clinical trials evaluating the impact of quarterly recovery management checkups with adult chronic substance users. Scott, CK., Dennis, ML.[2023]

Participants receiving the combination of Screening, Brief Intervention, and Referral to Treatment (SBIRT) plus Recovery Management Checkups for Primary Care (RMC-PC) were 3.85 times more likely to receive substance use disorder (SUD) treatment over 12 months compared to those receiving SBIRT alone, indicating a significant improvement in linkage to care.

The SBIRT+RMC-PC group also reported more days of abstinence and fewer days of substance use, demonstrating that regular checkups can enhance treatment engagement and reduce substance use in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of recovery management checkups for primary care patients: Twelve-month results. Scott, CK., Dennis, ML., Grella, CE., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8192586/

Improving Retention across the OUD Service Cascade ... The RMC-A experiment will test an adapted version of the evidence-based Recovery Management Checkups (RMC), which provides treatment linkage, support for ...

2. jcoinctc.org jcoinctc.org/standard-vs-adaptive-recovery-management-checkups-033/

Standard vs Adaptive Recovery Management Checkups (033) The Chestnut Health Systems JCOIN Research Center is comparing the effectiveness of the Recovery Management Checkups (RMC) model, an evidence-based ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S074054722030502X

Improving retention across the OUD service cascade upon ... The study compares the effectiveness of the recovery management checkups (RMC) model, an evidence-based intervention that provides regular, fixed schedule ...

4. recoveryanswers.org recoveryanswers.org/research-post/dynamic-duo-adding-recovery-management-checkups-sbirt-improves-patient-outcomes/

Adding recovery management checkups to SBIRT ... This study evaluated whether proven recovery management checkups that use assertive linkage as well as long-term monitoring and support add benefit to SBIRT.

5. ctv.veeva.com ctv.veeva.com/study/recovery-management-checkups-for-opioid-use-disorder-experiment

Recovery Management Checkups for Opioid Use Disorder ... 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 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04365920/recovery-management-checkups-for-opioid-use-disorder-experiment

Recovery Management Checkups for Opioid Use Disorder ... To date, three randomized controlled trials conducted by the study investigators have demonstrated RMC's effectiveness by increasing treatment ...

7. withpower.com withpower.com/trial/phase-3-substance-related-disorders-8-2021-ea026

Recovery Management Checkups for Opioid Use Disorder 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.