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
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
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
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
11. WHO Quality of Life-BREF (WHOQOL-BREF) score: Measured by self-report at 6 months
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.
- 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.
- (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.