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

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ClinicalTrials.gov Identifier: NCT02334215
Recruitment Status : Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Laura and John Arnold Foundation
Information provided by (Responsible Party):
Friends Research Institute, Inc.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Study Start Date : December 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in opioid urine test results [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
  2. Entry into treatment for opioid use disorder on the Methadone Treatment Exposure Form [ Time Frame: 30 days post-release from incarceration ]

Secondary Outcome Measures :
  1. Opioid Use Disorder 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 ]
  2. Number of arrests [ Time Frame: one year post-release from incarceration ]
  3. Drug Risk Score on the Risk Assessment Battery (RAB) [ Time Frame: 3, 6, and 12 months post-release from incarceration ]
  4. Sex Risk Score on the Risk Assessment Battery (RAB) [ Time Frame: 3, 6, and 12 months post-release from incarceration ]
  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 ]
  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 ]
  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 ]
  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 ]
  9. Overall quality of life item on the World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: 1, 3, 6, and 12 month post-release from incarceration ]
  10. Retention in treatment for opioid use disorder on the Methadone Treatment Exposure Form [ Time Frame: 12 months post-release from incarceration ]
  11. Number of days of criminal activity in the past 30 days on the Addiction Severity Index (ASI [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
  12. Number of days of illicit opioid use in the past 30 days on the Addiction Severity Index (ASI [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
  13. Number of days of cocaine use in the past 30 days on the Addiction Severity Index (ASI [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
  14. Cocaine Use Disorder in the past 30 days on the modified Composite International Diagnostic Interview (CIDI) [ Time Frame: 3, 6, and 12 months post-release from incarceration ]
  15. Health care utilization on the Economic Form 90 (EF-90) [ Time Frame: 1, 3, 6, and 12 months post-release from incarceration ]
  16. Cost of substance abuse services on the Substance Abuse Services Cost Analysis Program (SASCAP) [ Time Frame: 12 months post-release from incarceration ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334215


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02334215     History of Changes
Other Study ID Numbers: 3U01DA013636 ( U.S. NIH Grant/Contract )
3U01DA013636 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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