Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04365920
Other study ID # 1135-0519
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2021
Est. completion date April 30, 2025

Study information

Verified date March 2024
Source Chestnut Health Systems
Contact Michael L Dennis, PhD
Phone 309-451-7801
Email mdennis@chestnut.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This project aims to complement HEAL's Justice Community Opioid Innovation Network (JCOIN) initiative by focusing on post-release recovery in six county jails in Illinois with the goal of increasing linkage to and retention in community-based treatment with medication for opioid use disorder (MOUD) and reducing both opioid use disorder (OUD) relapse and criminal recidivism over two years. The study builds upon the platform of prior research demonstrating the effectiveness of the Recovery Management Checkups (RMC) intervention. To date, three randomized controlled trials conducted by the study investigators have demonstrated RMC's effectiveness by increasing treatment engagement and retention, re-linking recovering patients to treatment when indicated, and improving their health, psychosocial functioning, and other outcomes. Across these studies, relative to controls, participants in the RMC condition reported more treatment initiation, more days of treatment received, fewer days of substance use, and fewer health symptoms. In the proposed study, an adapted version of the RMC (RMC-A) will build upon the core components of the RMC by tailoring the checkup frequency to the individual's assessed need for treatment over time. The goal of the proposed experiment is to compare linkage and retention rates as well as public health and public safety outcomes of 750 male and female offenders who will be randomly assigned to 1 of 3 groups upon their release from jail: a) re-entry as usual (control), b) the original RMC, and c) a RMC-Adaptive version in which the frequency and content of checkups will be based upon the participant's ongoing progress as assessed by a set of indicators of treatment need. The study will be conducted in collaboration with 6 county jails in Illinois, and their local OTPs that currently provide pre-release MOUD to offenders with OUD. Pre-release participants will be screened for history of OUD and eligibility for MOUD following usual procedures. All participants will receive quarterly research follow-up assessments. Data sources include interviews with standardized measures, urine tests, treatment records to verify treatment received, recidivism, death records, and cost accounting. Research staff will administer the 25-minute Global Appraisal of Individual Needs - Quick (GAIN-Q3) and several supplemental scales at study enrollment, and again quarterly over 24 months post-study enrollment. The GAIN-Q3 includes 8 primary domains: 1) background, 2) school problems, 3) work problems, 4) physical health, 5) sources of stress, 6) HIV risk behaviors, 7) substance use, and 8) crime and violence. The response set captures the recency of these symptoms (life time, past year, past 90 days, past month) and treatment involvement, then the frequency (days) of behaviors/treatment utilization in the past 90 days. The GAIN-Q3 includes a behavioral health screener, health care utilization measures, measures of days of methadone treatment, heroin and other opioid use, days of other types of treatment, and other substance use. The GAIN-Q3 will be supplemented with the Quality of Life measure from the Patient Reported Outcomes Measurement Information System (PROMIS) - R. Data will be collected via a cloud-based computer program that controls ranges and skip-outs and identifies major inconsistencies for interviewers. All interviewers will receive extensive training and monitoring to ensure data quality. At the time of each in-person research assessment, on-site urine screens will be conducted with DrugCheck cups and fentanyl test strips using an immunoassay for rapid qualitative results based on SAMHSA-standard cutoffs for methadone and opiates/morphine in general, as well as specific tests for fentanyl, Oxycodone, and other substances. Research staff will be trained on a protocol that minimizes false negatives consistent with NIH's PhenX common data platform. The intervention focuses on improving elements in the OUD service cascade that have historically presented challenges, i.e., successful treatment linkage, engagement, and retention in community-based treatment post-release. With its emphasis on adapting an existing evidence-based intervention (RMC) to reduce high drop-out and increase retention in treatment with MOUD, it places individuals with OUD at lower risk for relapse, overdose, and death. The RMC model also proactively addresses the well-documented chronic cyclical nature of addiction, whereby individuals transition between being in treatment, in the community using, incarcerated, and in recovery. Findings from the study may help to target resources to those with demonstrated need, and reduce the intervention burden on those with lower need, thus resulting in an improved overall effectiveness and cost-effectiveness of RMC checkups.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - is under age 18 - has cognitive impairment that precludes ability to give informed consent - resides outside the service area.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Recovery Management Checkups (RMC)
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.
RMC-Adaptive
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.

Locations

Country Name City State
United States Chestnut Health Systems-Lighthouse Institute Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Chestnut Health Systems

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Opioid Use Disorder (OUD) service cascade Continuous time-to-event measures (based on date of discharge from jail) and dichotomous measures (yes/no) of whether each of the following events happen: a) initiation of treatment with MOUD, b) engagement in MOUD treatment for at least 6 weeks, c) retention in MOUD treatment for at least 90 days (median in national data), and d) retention for at least 6 months, as well as times from post-drop out and relapse to re-linkage to MOUD; largely used descriptively. 24 months
Secondary Days of Opioid Use A self-reported count 0 to 90 days of using any kind of opioids each quarter (test-retest rho=.95; ICC=.34 across quarters). There will also be additional measures of the days of using heroin, fentanyl, and prescription opioid misuse for descriptive use. All come from a standardized assessment tool, the Global Appraisal of Individual Needs (GAIN). 90 days
Secondary Opioid Use Disorder (OUD) Symptoms A self-reported count of the 0 to 11 the Diagnostic and Statistical Manual version 5 (DSM-5) symptoms of Opioid Use Disorders (OUD) each quarter from the GAIN (alpha=.95; ICC=.28 across quarters). There will also be alternative measures for OUD symptoms in the past month, year, and lifetime, as well as a measure of DSM-5 symptoms across other SUD each quarter. 90 days
Secondary Quality of Life (QoL): self-reported frequency of problems and strengths This is a quarterly self-reported frequency of problems in with reference to the past 7 days in 8 domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and cognitive function ability, and an overall measure of pain intensity from the Patient Reported Outcomes Measurement Information System (PROMIS). Scored on a scale from 0 (near death) to 100 (best health). 7 days
Secondary Costs-of-Healthcare-Utilization This cost measure is based on the self-reported frequency of healthcare services related to substance use, mental health, and physical health, measured in units such as "days," "visits," or "episodes", which are multiplied by corresponding monetary conversion factors (price weights for a unit of service) to estimate a continuous "total healthcare costs" variable and trimmed at the 99% percentile due to sharp right skews (ICC=.27 across quarters). The self-report questions come from the GAIN. 90 days
Secondary Illegal Activity This is a self-reported count of 19 items across different types of illegal activities related to property crimes (e.g., vandalism, bad checks, theft, breaking and entering), personal crime (e.g., assault, rape, murder), and substance use (driving under the influence, distribution, prostitution, gang membership, gambling) in the past quarter (alpha=.9; ICC=.20 across quarters). These self-report questions come from the GAIN. A count of the number of types of crimes committed in the 24 months. 24 months
Secondary Re-arrest and Re-incarceration A dichotomous measure of whether the person has been re-arrested or re-incarcerated on any charge within 24 months. 24 months
Secondary Costs-of-Crime This cost measure is based on the self-reported frequency of 12 criminal offenses times their respective societal cost per offense based on the most recent economic estimate, which will be used to estimate a continuous "total cost-of-crime" variable in whole dollars and trimmed at the 99% percentile due to sharp right skews (ICC=.03). The self-report questions come from the GAIN. 90 days
Secondary Quality Adjusted Life Years (QALYs) This measure is based on the Patient Reported Outcomes Measurement Information System (PROMIS) - R. It is the self-reported frequency of problems in with reference to the past 7 days in 8 domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and cognitive function ability, and an overall measure of pain intensity. QALY (0-100%) times 0.25 years for each quarter and summed across 8 quarters/24 months post-release. While missing data will be imputed, from a point of death on will be treated as 0. In addition to being compared between groups, data can be scaled to U.S. norms using the AHSR data. 24 months
See also
  Status Clinical Trial Phase
Recruiting NCT04157062 - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder N/A
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Completed NCT04505540 - Start Treatment and Recovery for Opioid Use Disorder N/A
Completed NCT03065049 - Transforming Recovery Through Exercise and Community N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Active, not recruiting NCT04650386 - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients N/A
Completed NCT03715634 - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine Phase 1
Enrolling by invitation NCT04991974 - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine Phase 2/Phase 3
Completed NCT04122755 - Single Ascending Dose Study of ALA-1000 Phase 1
Recruiting NCT05049460 - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder N/A
Recruiting NCT05028998 - COVID-19-Related Opioid Treatment Policy Evaluation
Recruiting NCT04927143 - Encouraging Abstinence Behavior in a Drug Epidemic Phase 2
Completed NCT05047627 - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder N/A
Active, not recruiting NCT04129580 - reSET-O RCT (Randomized Controlled Trial) N/A
Recruiting NCT03923374 - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed NCT04464421 - SMART Effectiveness Trial N/A
Suspended NCT02687360 - Imaging the Effects of rTMS on Chronic Pain N/A
Completed NCT04056182 - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment Phase 2