A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail

Friends Research Institute, Inc.225 enrolled

Overview

The purpose of this study is to determine which of three approaches started in jail is more effective in treating opioid use disorder: (1) methadone treatment without counseling (termed interim methadone) coupled with case management (termed patient navigation); (2) interim methadone without patient navigation; (3) or an enhanced treatment as usual including opioid detoxification, overdose prevention and drug treatment information and referral.

This study is part of the NIDA "Studies of Medication for Addiction Treatment in Correctional Settings (SOMATICS)" U01 Collaborative. Our distinct NIH-funded study at Friends Research Institute has been aligned with two other jail-based opioid treatment studies conducted by researchers at New York University (NYU) and at University of California Los Angeles (UCLA). SOMATICS seeks to harmonize assessments and interventions across the three research centers (RCs) and the three independent studies in order to leverage power, sample size, and increase the generalizability of findings. Each of the RCs in the SOMATICS cooperative will conduct their own individual trial, sharing one study arm with another RC, and several core assessments across all sites. The SOMATICS collaborative will have a common Statistical Analysis Plan and Data and Safety Monitoring Plan (DSMP) including a single DSMB. The collaborative primary and secondary outcomes across all sites are listed below: Collaborative Primary Outcome Measure: 1\. DSM-5 Opioid Use Disorder Diagnosis during the 30 days prior to the 6 months post-release follow-up assessment: Measured by: modified World Mental Health Composite International Diagnostic Interview. Collaborative Secondary Outcome Measures: 1. Illicit Opioid use: measured by urine drug testing results at 6 months post-release 2. Number of days incarcerated: Measured by self-report during the 6 months post-release. 3. HIV risk behavior: Measured by self-report (Drug Risk Assessment Battery \[RAB\] Needle Use score) at the 6-month post-release follow-up assessment. 4. Number of days of Opioids, Cocaine, Alcohol, Benzodiazepines, and/or IV Drug Use: Measured by Time Line Follow Back at 6 months post-release follow-up (TLFB; NYU, UCLA) and ASI (FRI). 5. Non-opioid drug use (Cocaine, Amphetamines, and Benzodiazepines): measured by urine drug testing at 6 months post-release 6. Number of days in any drug abuse treatment: Measured by self-report at 6 months post-release. 7. Number of arrests: Measured by self-report data collected at 6 months post-release. 8. Craving scores (for NYU and UCLA sites only): Measured by self-report craving scale at 6 months post-release. 9. Non-lethal overdose (Yes/No): Measured by self-report during the 6 months post-release. 10. Lethal overdose (Yes/No): Measured by public records data reviewed at 6 months post-release. 11. WHO Quality of Life-BREF (WHOQOL-BREF) score: Measured by self-report at 6 months post-release. 12. Analyses of above self-same outcomes at 12 months follow-up. 13. Once the primary trial is complete, the site in Baltimore will collect longer-term outcome data at a 24-month follow-up point through funding from the Arnold Foundation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

225

Conditions

Opioid Use Disorder

Interventions

MethadoneDRUG

Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.

Patient NavigationBEHAVIORAL

A patient navigator will assist the participant for the first three months after release from jail to enter and remain in methadone treatment in the community.

Enhanced Treatment as Usual (ETAU)BEHAVIORAL

Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\) Meets Diagnostic and Statistical Manual -5 (DSM-5) criteria for opioid use disorder; (2) detained for at least 48 hours; (3) receiving opioid withdrawal treatment (as-usual) through the Detention Center's medical providers; (4) able and willing to provide informed consent in English; (5) detained for a charge that, if found guilty, will result in a sentence of less than 1 year; (6) plan to reside in Baltimore upon release; (7) 18 years of age and older. Exclusion Criteria: * (1) enrolled in methadone or buprenorphine treatment in the community at the time of arrest; (2) having a medical (liver failure, congestive heart failure) or psychiatric condition (e.g., suicidal ideation, psychosis) that would make participation unsafe in the judgment of the medical staff or the PI; (3) pregnancy; (4) allergy to methadone; and, (5) requiring treatment for alcohol or sedative hypnotic withdrawal.

Locations (1)

Baltimore City Detention Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time

Predicted probability derived from the generalized linear mixed model opioid positive urine tests (0= negative; 1- positive) for heroin, oxycodone, methadone, or buprenorphine -- excluding the latter two positives when they results from prescribed medications to treat opioid use disorder)

Time frame: 1, 3, 6, and 12 months post-release from incarceration

Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form

Predicted probability derived from the general linear mixed model of self-reported entry into treatment for opioid use disorder following release from incarceration and being in treatment 30 days post-release (0= no entry in treatment; 1= entry in treatment).

Time frame: 30 days post-release from incarceration

Secondary Outcomes

Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)

Predicted probability derived from the Generalized Linear Mixed Model of meeting the Data and Statistical Manual - 5 criteria for Opioid Use Disorder in response to modified CIDI interview (0= does not meet criteria; 1= meets criteria).

Time frame: one month period prior to the 3, 6, and 12 month post-release from incarceration

Number of Participants With Arrests

Official data on participant arrests subsequent to release from index incarceration.

Time frame: one year post-release from incarceration

Drug Risk Score on the Risk Assessment Battery (RAB)

Drug Risk Scale Score on the Risk Assessment Battery. The scale's range goes from 0 to 22. Higher score represents greater frequency of drug risk behaviors

Data from ClinicalTrials.gov

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