Recovery Management Checkups for Opioid Use Disorder Experiment

NCT04365920 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 1135-0519
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

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

  A continuous measure of months of treatment with MOUD received from opioid treatment provider records (Interclass Correlation Coefficient \[ICC\]=.37 when measured quarterly). The count will be based on days of medication received (including any take-home dosages); injectable naltrexone will be counted as treatment for 30 days. Missing records data will be estimated from self-report.

  24 months

Secondary Outcomes (9)

• Opioid Use Disorder (OUD) service cascade

  24 months

• Days of Opioid Use

  90 days

• Opioid Use Disorder (OUD) Symptoms

  90 days

• Quality of Life (QoL): self-reported frequency of problems and strengths

  7 days

• Costs-of-Healthcare-Utilization

  90 days

Study Arms (3)

Re-Entry as Usual

NO 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.

Recovery Management Checkups (RMC)

EXPERIMENTAL

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.

Combination Product: Recovery Management Checkups (RMC)

RMC-Adaptive

EXPERIMENTAL

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.

Combination Product: RMC-Adaptive

Interventions

Recovery Management Checkups (RMC) COMBINATION_PRODUCT

The RMC model was designed to improve treatment linkage, engagement, and long-term treatment retention. The conceptual framework was based on the public health theory of chronic disease management, which utilizes ongoing assessment and monitoring through regular face-to-face checkups and early (re)intervention to facilitate detection of relapse, reduce the time to treatment re-entry, and consequently, improve long-term outcomes. The original RMC model includes: 1) a fixed schedule of face-to-face quarterly checkups to assess need for SUD treatment, 2) personalized feedback based on an assessment and motivational interviewing to increase treatment motivation, 3) problem solving around barriers to treatment access and retention, and 4) assistance with scheduling and linkage to treatment. Individuals were deemed to be in "need of treatment" if they reported weekly, or more frequent, substance use since the last checkup, any past-month SUD symptoms, or self-perceived need for treatment.

Recovery Management Checkups (RMC)

RMC-Adaptive COMBINATION_PRODUCT

Participants in the RMC-Adaptive group will receive face-to-face monthly checkups during the first 2 months post-release with additional face-to-face checkups dependent upon the participant's progress. Based on the data presented in the prior section, as long as participants need treatment, they will receive monthly checkups. In addition, for every checkup that a participant does NOT need treatment, the number of months before the next checkup will be increased by 1 month (e.g., after 2 checkups without need, they will receive the next checkup 2 months later, after 3 it will be 3 months, after 4 it will be 4 months, and so on). Based on these decision rules, individuals who have NO treatment need over 24 months will still receive 5 checkups.

RMC-Adaptive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meets DSM-5 opioid use disorder criteria in the past year
• reports heroin or other opioid use in the 90 days prior to entering jail
• is released from 1 of the participating jails.

You may not qualify if:

• is under age 18
• has cognitive impairment that precludes ability to give informed consent
• resides outside the service area.

Sponsors & Collaborators

• Chestnut Health Systems: lead

Study Sites (1)

Chestnut Health Systems-Lighthouse Institute

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael L Dennis, PhD

  Chestnut Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Development

Model Details: Re-Entry as Usual; Recovery Management Checkups (RMC); RMC-Adaptive

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: April 28, 2020
• Study Start: August 29, 2021
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)