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

Condition(s) targeted: Opioid Use Disorder

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

Phase: N/A

Status: Recruiting

Sponsored by: Friends Research Institute, Inc.

Overall contact:
Sharon M Kelly, Ph.D., Phone: 410-837-3977, Ext: 273, Email: skelly@friendsresearch.org

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Change in opioid urine test results

Entry into treatment for opioid use disorder on the Economic Form-90 (EF-90)

Secondary outcome:

Opioid Use Disorder as determined by the modified Composite International Diagnostic Interview (CIDI)

Number of arrests

Number of Incarcerations

Drug Risk Score on the Risk Assessment Battery (RAB)

Sex Risk Score on the Risk Assessment Battery (RAB)

Physical domain score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

Psychological domain score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

Social domain score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

Environmental domain score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

Overall quality of life item on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

Number of days of treatment for opioid use disorder on the Economic Form-90

Number of days of criminal activity in the past 30 days on the Addiction Severity Index (ASI

Number of days of illicit opioid use in the past 30 days on the Addiction Severity Index (ASI

Number of days of cocaine use in the past 30 days on the Addiction Severity Index (ASI

Cocaine Use Disorder in the past 30 days on the modified Composite International Diagnostic Interview (CIDI)

Health care utilization on the Economic Form 90 (EF-90)

Cost of substance abuse services on the Substance Abuse Services Cost Analysis Program (SASCAP)

Detailed 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: DSM-5 checklist via a modified CIDI-2 Substance Abuse Module. 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Sharon M Kelly, Ph.D., Phone: 410-837-3977, Ext: 273, Email: skelly@friendsresearch.org

Baltimore City Detention Center, Baltimore, Maryland 21202, United States; Recruiting
Sharon M Kelly, Ph.D., Phone: 410-837-3977, Ext: 273, Email: skelly@friendsresearch.org
Robert P Schwartz, M.D., Principal Investigator
Jerome H Jaffe, M.D., Sub-Investigator
Sharon M Kelly, Ph.D., Sub-Investigator
Laura Dunlap, Ph.D., Sub-Investigator
Gary Zarkin, Ph.D., Sub-Investigator

Starting date: December 2014
Last updated: March 5, 2015