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

Friends Research Institute

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Behavioral: Patient Navigation; Drug: Methadone; Behavioral: Enhanced Treatment as Usual (ETAU)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02334215

3U01DA013636 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

Methadone plus Patient Navigation

Experimental group

Description:

Participants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention.

Treatment:

Drug: Methadone

Behavioral: Patient Navigation

Methadone

Experimental group

Description:

Participants will begin methadone during detention.

Treatment:

Drug: Methadone

Enhanced Treatment as Usual

Active Comparator group

Description:

Participants will receive opioid detoxification during detention, as well as drug abuse education, overdose prevention education, and referral to drug abuse treatment and overdose prevention services in the community.

Treatment:

Behavioral: Enhanced Treatment as Usual (ETAU)