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

• ClinicalTrials.gov Identifier: NCT02334215
• Recruitment Status: Completed
• First Posted: January 8, 2015
• Results First Posted: September 16, 2020
• Last Update Posted: September 16, 2020
• Sponsor: Friends Research Institute, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Laura and John Arnold Foundation
• Information provided by (Responsible Party): Friends Research Institute, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use Disorder	Drug: Methadone; Behavioral: Patient Navigation; Behavioral: Enhanced Treatment as Usual (ETAU)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
• Actual Study Start Date: December 15, 2014
• Actual Primary Completion Date: March 8, 2019
• Actual Study Completion Date: May 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Methadone plus Patient Navigation; Participants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention.	Drug: Methadone; Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.; Behavioral: Patient Navigation; A patient navigator will assist the participant for the first three months after release from jail to enter and remain in methadone treatment in the community.
Experimental: Methadone; Participants will begin methadone during detention.	Drug: Methadone; Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.
Active Comparator: Enhanced Treatment as Usual; 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.	Behavioral: Enhanced Treatment as Usual (ETAU); Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community.

Outcome Measures

Primary Outcome Measures :

1. Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
   Predicted probability derived from the generalized linear mixed model opioid positive urine tests (0= negative; 1- positive) for heroin, oxycodone, methadone, or buprenorphine -- excluding the latter two positives when they results from prescribed medications to treat opioid use disorder)
2. Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form [ Time Frame: 30 days post-release from incarceration ]
   Predicted probability derived from the general linear mixed model of self-reported entry into treatment for opioid use disorder following release from incarceration and being in treatment 30 days post-release (0= no entry in treatment; 1= entry in treatment).

Secondary Outcome Measures :

1. Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) [ Time Frame: one month period prior to the 3, 6, and 12 month post-release from incarceration ]
   Predicted probability derived from the Generalized Linear Mixed Model of meeting the Data and Statistical Manual - 5 criteria for Opioid Use Disorder in response to modified CIDI interview (0= does not meet criteria; 1= meets criteria).
2. Number of Participants With Arrests [ Time Frame: one year post-release from incarceration ]
   Official data on participant arrests subsequent to release from index incarceration.
3. Drug Risk Score on the Risk Assessment Battery (RAB) [ Time Frame: Baseline and 6, and 12 months post-release from incarceration ]
   Drug Risk Scale Score on the Risk Assessment Battery. The scale's range goes from 0 to 22. Higher score represents greater frequency of drug risk behaviors
4. Sex Risk Score on the Risk Assessment Battery (RAB) [ Time Frame: Baseline and 6, and 12 months post-release from incarceration ]
   Sex Risk Score on the Risk Assessment Battery (RAB). Higher scores represents greater risk. The score ranges from 0 to 18.
5. Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: 1, 3, 6, and 12 months post-incarceration ]
   The score on the Physical Domain Scale of the World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF). The scales range is from 0 to 100. The higher score represents better quality of life.
6. Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
   Scale score on the Psychological Domain on the World Health Organization Quality of Life Scale (WHOQOL-BREF) goes from 1 to 100. The higher score represents a better quality of life.
7. Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: 1, 3, 6, and 12 month post-release from incarceration ]
   Social domain scale score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) goes from 1 to 100. The higher score represents a better quality of life.
8. Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
   Environmental domain score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) goes from 1 to 100. A higher score represents a better quality of life.
9. Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: 1, 3, 6, and 12 month post-release from incarceration ]
   Self report quality of life as reported by participants following release from their index incarceration on a scale from 1 to 5. A higher score is a better outcome.
10. Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form [ Time Frame: 12 months post-release from incarceration ]
    Predicted Probability derived from the Generalized Linear Mixed of self-reported enrolled in treatment for Opioid Use Disorder at the time of the follow-up interview (0=not enrolled; 1=enrolled).
11. Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
    Mean number of days reported by participants of their criminal activity during the 30 days preceding the Addiction Severity Index interviews
12. Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
    Mean number of participant self-reported days of heroin use in the 30 days preceding the interview on the Addiction Severity Index (ASI)
13. Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
    Participant self-reported mean number of days of cocaine use in the 30 days preceding the interview on the Addiction Severity Index (ASI)
14. Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days [ Time Frame: 3, 6, and 12 months post-release from incarceration ]
    Predicted Probability Derived from the Generalized Linear Mixed Model meeting Data and Statistical Manual - 5 criteria for Cocaine Use Disorder on the modified Composite International Diagnostic Interview (CIDI) (0=Does not meet criteria; 1=meets criteria).
15. Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90) [ Time Frame: 12 months post-release from incarceration ]
    Mean number of days hospitalized during the 12 months post-release from incarceration
16. Cost of Substance Abuse Services [ Time Frame: 12 months post-release from incarceration ]
    Cost in US Dollars of substance abuse services on the modified Substance Abuse Services Cost Analysis Program

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Maryland

Baltimore City Detention Center

Baltimore, Maryland, United States, 21202

Sponsors and Collaborators

Friends Research Institute, Inc.

National Institute on Drug Abuse (NIDA)

Laura and John Arnold Foundation

  Study Documents (Full-Text)

Documents provided by Friends Research Institute, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] August 9, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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. Erratum In: Contemp Clin Trials. 2016 Nov;51:97.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT02334215
• Other Study ID Numbers: 3U01DA013636 ( U.S. NIH Grant/Contract ); 3U01DA013636 ( U.S. NIH Grant/Contract )
• First Posted: January 8, 2015
• Results First Posted: September 16, 2020
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

Additional relevant MeSH terms:

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Methadone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antitussive Agents; Respiratory System Agents