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

Opioid Use Disorder Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Opioid Use Disorder

• NCT number: NCT02334215
• Study type: Interventional
• Source: Friends Research Institute, Inc.
• Status: Completed
• Phase: N/A
• Start date: December 15, 2014
• Completion date: May 2020