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

NCT02334215 | Completed Results DMC

• 1 other identifier: 3U01DA013636
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time

  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)

  1, 3, 6, and 12 months post-release from incarceration

• Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form

  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).

  30 days post-release from incarceration

Secondary Outcomes (16)

• Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)

  one month period prior to the 3, 6, and 12 month post-release from incarceration

• Number of Participants With Arrests

  one year post-release from incarceration

• Drug Risk Score on the Risk Assessment Battery (RAB)

  Baseline and 6, and 12 months post-release from incarceration

• Sex Risk Score on the Risk Assessment Battery (RAB)

  Baseline and 6, and 12 months post-release from incarceration

• Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

  1, 3, 6, and 12 months post-incarceration

Study Arms (3)

Methadone plus Patient Navigation

EXPERIMENTAL

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

Drug: Methadone; Behavioral: Patient Navigation

Methadone

EXPERIMENTAL

Participants will begin methadone during detention.

Drug: Methadone

Enhanced Treatment as Usual

ACTIVE COMPARATOR

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)

Interventions

Methadone DRUG

Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.

Methadone; Methadone plus Patient Navigation

Patient Navigation BEHAVIORAL

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.

Methadone plus Patient Navigation

Enhanced Treatment as Usual (ETAU) BEHAVIORAL

Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community.

Enhanced Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Laura and John Arnold Foundation: collaborator

Study Sites (1)

Baltimore City Detention Center

Baltimore, Maryland, 21202, United States

Location

Related Publications (4)

• 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.

  PMID: 33196937 DERIVED

• 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.

  PMID: 33187759 DERIVED

• 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.

  PMID: 31748939 DERIVED

• 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.

  PMID: 27282117 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methadone; Patient Navigation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Robert P. Schwartz, M.D.
• Organization: Friends Research Institute

rschwartz@friendsresearch.org

410-837-3977

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: January 8, 2015
• Study Start: December 15, 2014
• Primary Completion: March 8, 2019
• Study Completion: May 1, 2020
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Locations

US (1)