Clinical trial NCT02334215: A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
Official title: A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Laura and John Arnold Foundation
First posted: 2015-01-08
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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: 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.

Eligibility 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.

Primary outcomes:
measure: Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time
timeFrame: 1, 3, 6, and 12 months post-release from incarceration
measure: Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form
timeFrame: 30 days post-release from incarceration
Secondary outcomes:
measure: Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)
timeFrame: one month period prior to the 3, 6, and 12 month post-release from incarceration
measure: Number of Participants With Arrests
timeFrame: one year post-release from incarceration
measure: Drug Risk Score on the Risk Assessment Battery (RAB)
timeFrame: Baseline and 6, and 12 months post-release from incarceration
measure: Sex Risk Score on the Risk Assessment Battery (RAB)
timeFrame: Baseline and 6, and 12 months post-release from incarceration
measure: Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: 1, 3, 6, and 12 months post-incarceration
measure: Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: 1, 3, 6, and 12 months post-release from incarceration
measure: Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: 1, 3, 6, and 12 month post-release from incarceration
measure: Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: 1, 3, 6, and 12 months post-release from incarceration
measure: Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: 1, 3, 6, and 12 month post-release from incarceration
measure: Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form
timeFrame: 12 months post-release from incarceration
measure: Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI)
timeFrame: 1, 3, 6, and 12 months post-release from incarceration
measure: Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days
timeFrame: 1, 3, 6, and 12 months post-release from incarceration
measure: Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days
timeFrame: 1, 3, 6, and 12 months post-release from incarceration
measure: Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days
timeFrame: 3, 6, and 12 months post-release from incarceration
measure: Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90)
timeFrame: 12 months post-release from incarceration
measure: Cost of Substance Abuse Services
timeFrame: 12 months post-release from incarceration
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Detention Center
state: Maryland
Study officials:
References:
citation: Mitchell MM, Kelly SM, O'Grady KE, Jaffe JH, Mitchell SG, Schwartz RP. HIV-Risk Behavior Among Adults with Opioid Use Disorder During 12 Months Following Pre-trial Detention: Results from a Randomized Trial of Methadone Treatment. AIDS Behav. 2021 Apr;25(4):1247-1256. doi: 10.1007/s10461-020-03090-y. Epub 2020 Nov 16.
citation: Schwartz RP, Kelly SM, Mitchell SG, O'Grady KE, Duren T, Sharma A, Gryczynski J, Jaffe JH. Randomized trial of methadone treatment of arrestees: 24-month post-release outcomes. Drug Alcohol Depend. 2021 Jan 1;218:108392. doi: 10.1016/j.drugalcdep.2020.108392. Epub 2020 Nov 2.
citation: Mitchell MM, Gryczynski J, Mitchell SG, Kelly SM, O'Grady KE, Monico LB, Schwartz RP. A Latent Class Analysis of HIV Risk Factors Among Men and Women with Opioid Use Disorder in Pre-trial Detention. AIDS Behav. 2020 Jun;24(6):1776-1783. doi: 10.1007/s10461-019-02726-y.
citation: Schwartz RP, Kelly SM, Mitchell SG, Dunlap L, Zarkin GA, Sharma A, O'Grady KE, Jaffe JH. Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial. Contemp Clin Trials. 2016 Jul;49:21-8. doi: 10.1016/j.cct.2016.06.002. Epub 2016 Jun 7.