N/A N=225 Randomized Health Services Research

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

Opioid Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02334215 ↗

Enrolled (actual)

225

Serious AEs

20.9%

Results posted

Sep 2020

Primary outcome: Primary: Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time — 0.70; 0.72; 0.66; 0.59 Probability — p=.32

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Methadone (Drug); Patient Navigation (Behavioral); Enhanced Treatment as Usual (ETAU) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Friends Research Institute, Inc.
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time	0.70; 0.72; 0.66; 0.59; 0.72; 0.73	.32
PRIMARY Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form	0.65; 0.62; 0.225	.001 sig
SECONDARY Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)	0.66; 0.70; 0.76; 0.51; 0.59; 0.77	0.11
SECONDARY Number of Participants With Arrests	32; 39; 36	0.55
SECONDARY Drug Risk Score on the Risk Assessment Battery (RAB)	2.30; 2.43; 3.11; 1.52; 1.81; 2.16	.997
SECONDARY Sex Risk Score on the Risk Assessment Battery (RAB)	4.52; 4.78; 4.68; 3.93; 3.94; 4.27	.663
SECONDARY Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)	54.6; 58.3; 57.1; 62.8; 62.2; 68.7	0.007 sig
SECONDARY Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)	56.8; 56.9; 55.9; 65.5; 64.0; 66.7	0.60
SECONDARY Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)	56.9; 57.7; 51.3; 63.6; 57.5; 64.9	.09
SECONDARY Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)	48.0; 54.6; 54.9; 56.1; 63.6; 65.1	.013 sig
SECONDARY Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)	2.7; 2.8; 3.1; 3.49; 3.56; 3.40	.32
SECONDARY Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form	.63; .56; .26; .57; .47; .19	.10
SECONDARY Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI)	5.22; 8.18; 8.22; 9.79; 9.35; 10.59	.42
SECONDARY Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days	8.66; 12.07; 14.88; 13.46; 15.15; 16.18	.28
SECONDARY Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days	5.95; 9.05; 11.01; 8.83; 11.32; 11.94	.61
SECONDARY Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days	.20; .32; .32; .22; .35; .36	.71
SECONDARY Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90)	2.0; 3.4; 1.2	—
SECONDARY Cost of Substance Abuse Services	3052; 2377; 1884	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02334215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.