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CompletedNCT02334215SOMATICS FRIUpdated Sep 16, 2020Results posted

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

An interventional study of Methadone and Patient Navigation in Opioid Use Disorder, sponsored by Friends Research Institute, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Friends Research Institute, Inc. · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Opioid Use Disorder
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 225 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Friends Research Institute, Inc. is the lead sponsor of 44 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
225 participants (actual)

Study arms

  • 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 · Behavioral: Patient Navigation

  • Experimental
    Methadone

    Participants will begin methadone during detention.

    Drug: Methadone

  • 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)

Interventions

  • DrugMethadone

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

  • BehavioralPatient 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.

  • BehavioralEnhanced Treatment as Usual (ETAU)

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

06

What researchers measure

Primary outcomes

  1. 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)

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

  2. 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).

    Time frame: 30 days post-release from incarceration

Secondary outcomes

  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)

    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).

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

  2. Number of Participants With Arrests

    Official data on participant arrests subsequent to release from index incarceration.

    Time frame: one year post-release from incarceration

  3. Drug Risk Score on the Risk Assessment Battery (RAB)

    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

    Time frame: Baseline and 6, and 12 months post-release from incarceration

  4. Sex Risk Score on the Risk Assessment Battery (RAB)

    Sex Risk Score on the Risk Assessment Battery (RAB). Higher scores represents greater risk. The score ranges from 0 to 18.

    Time frame: Baseline and 6, and 12 months post-release from incarceration

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

    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.

    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)

    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.

    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)

    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.

    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)

    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.

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

  9. Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

    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.

    Time frame: 1, 3, 6, and 12 month post-release from incarceration

  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

    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).

    Time frame: 12 months post-release from incarceration

  11. Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI)

    Mean number of days reported by participants of their criminal activity during the 30 days preceding the Addiction Severity Index interviews

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

  12. Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days

    Mean number of participant self-reported days of heroin use in the 30 days preceding the interview on the Addiction Severity Index (ASI)

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

  13. Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days

    Participant self-reported mean number of days of cocaine use in the 30 days preceding the interview on the Addiction Severity Index (ASI)

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

  14. Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days

    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).

    Time frame: 3, 6, and 12 months post-release from incarceration

  15. Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90)

    Mean number of days hospitalized during the 12 months post-release from incarceration

    Time frame: 12 months post-release from incarceration

  16. Cost of Substance Abuse Services

    Cost in US Dollars of substance abuse services on the modified Substance Abuse Services Cost Analysis Program

    Time frame: 12 months post-release from incarceration

07

Results

Posted Sep 16, 2020

Participant flow

Participant flow — Overall Study
MilestoneMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Started757476
Completed686861
Not completed7615
Withdrew: Death110
Withdrew: Lost to follow-up104
Withdrew: Withdrawal by subject221
Withdrew: Not released from incarceration on time333
Withdrew: Incarcerated007

Outcome measures

PrimaryPredicted 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)

Time frame:
1, 3, 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · Probability
Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time
ProbabilityMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
1 month post-release from incarceration0.70 ± 0.080.72 ± 0.090.66 ± 0.09
3 months post-release from incarceration0.59 ± 0.080.72 ± 0.090.73 ± 0.08
6 months post-release from incarceration0.49 ± 0.090.63 ± 0.100.71 ± 0.08
12 months post-release from incarceration0.46 ± 0.080.71 ± 0.090.59 ± 0.09
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .32
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = .32
PrimaryPredicted 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).

Time frame:
30 days post-release from incarceration
Reported as:
Least squares mean · Probability
Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form
ProbabilityMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form0.65 ± 0.090.62 ± 0.100.225 ± 0.09
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .001
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = .84
SecondaryPredicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)

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).

Time frame:
one month period prior to the 3, 6, and 12 month post-release from incarceration
Reported as:
Least squares mean · Probability
Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)
ProbabilityMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
3 months post-release from incarceration0.66 ± 0.090.70 ± 0.080.76 ± 0.08
6 months post-release from incarceration0.51 ± 0.090.59 ± 0.090.77 ± 0.08
12 months post-release from incarceration0.54 ± 0.090.77 ± 0.110.59 ± 0.09
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = 0.11
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 0.55
SecondaryNumber of Participants With Arrests

Official data on participant arrests subsequent to release from index incarceration.

Time frame:
one year post-release from incarceration
Reported as:
Count of participants · Participants
Number of Participants With Arrests
ParticipantsMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Number of Participants With Arrests323936
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Regression, Logistic · p = 0.55
  • Methadone Plus Patient Navigation vs Methadone · Regression, Logistic · p = 0.57
SecondaryDrug Risk Score on the Risk Assessment Battery (RAB)

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

Time frame:
Baseline and 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · score on a scale
Drug Risk Score on the Risk Assessment Battery (RAB)
score on a scaleMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Baseline2.30 ± .572.43 ± .623.11 ± .76
6 month post-release from incarceration1.52 ± .521.81 ± .652.16 ± .73
12 month post-release.50 ± .251.35 ± .591.03 ± .44
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model · p = .997
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 0.26
SecondarySex Risk Score on the Risk Assessment Battery (RAB)

Sex Risk Score on the Risk Assessment Battery (RAB). Higher scores represents greater risk. The score ranges from 0 to 18.

Time frame:
Baseline and 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · score on a scale
Sex Risk Score on the Risk Assessment Battery (RAB)
score on a scaleMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Baseline4.52 ± .344.78 ± .354.68 ± .34
6 months post-release3.93 ± .343.94 ± .354.27 ± .36
12 month post-release3.78 ± .364.61 ± .424.17 ± .38
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model · p = .663
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 0.33
SecondaryPhysical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

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.

Time frame:
1, 3, 6, and 12 months post-incarceration
Reported as:
Least squares mean · score on a scale
Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
score on a scaleMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Baseline54.6 ± 2.858.3 ± 3.057.1 ± 2.8
1 months post-release from incarceration62.8 ± 3.062.2 ± 3.468.7 ± 3.4
3 months post-release from incarceration60.3 ± 3.160.1 ± 3.167.3 ± 3.2
6 months post-release from incarceration68.6 ± 3.166.3 ± 3.261.2 ± 3.0
12 months post-release from incarceration63.1 ± 3.063.8 ± 3.260.3 ± 3.0
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = 0.007
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = .76
SecondaryPsychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

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.

Time frame:
1, 3, 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · score on a scale
Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
score on a scaleMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Baseline56.8 ± 2.856.9 ± 3.055.9 ± 3.0
1 month post-release from incarceration65.5 ± 3.164.0 ± 3.566.7 ± 3.5
3 months post-release from incarceration62.6 ± 3.461.2 ± 3.366.6 ± 3.4
6 months post-release from incarceration64.9 ± 3.563.9 ± 3.664.8 ± 3.4
12 months post-release from incarceration62.0 ± 3.261.8 ± 3.464.4 ± 3.3
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = 0.60
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 1.0
SecondarySocial Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

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.

Time frame:
1, 3, 6, and 12 month post-release from incarceration
Reported as:
Least squares mean · score on a scale
Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
score on a scaleMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Baseline56.9 ± 3.957.7 ± 4.051.3 ± 3.9
1 month post-release from incarceration63.6 ± 3.957.5 ± 4.464.9 ± 4.4
3 months post-release from incarceration60.9 ± 4.162.4 ± 4.066.4 ± 4.1
6 months post-release from incarceration63.3 ± 3.863.3 ± 3.958.8 ± 3.7
12 months post-release from incarceration56.6 ± 4.355.4 ± 4.559.1 ± 4.3
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .09
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = .74
SecondaryEnvironmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

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.

Time frame:
1, 3, 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · score on a scale
Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
score on a scaleMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Baseline48.0 ± 3.054.6 ± 3.154.9 ± 3.0
1 months post-release from incarceration56.1 ± 2.963.6 ± 3.365.1 ± 3.3
3 months post-release from incarceration51.9 ± 3.255.1 ± 3.263.7 ± 3.3
6 months post-release from incarceration59.0 ± 3.360.6 ± 3.457.2 ± 3.2
12 months post-release from incarceration54.8 ± 3.259.4 ± 3.459.3 ± 3.3
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .013
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = .71
SecondaryOverall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)

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.

Time frame:
1, 3, 6, and 12 month post-release from incarceration
Reported as:
Least squares mean · units on a scale
Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
units on a scaleMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Baseline2.7 ± 1.62.8 ± .163.1 ± .16
1 month post-release from incarceration3.49 ± .1623.56 ± .193.40 ± .19
3 months post-release from incarceration3.15 ± .173.46 ± .173.57 ± .17
6 months post-release from incarceration3.51 ± .173.58 ± .183.53 ± .17
12 months post-release from incarceration3.29 ± .173.43 ± .183.45 ± .17
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .32
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 0.85
SecondaryPredicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form

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).

Time frame:
12 months post-release from incarceration
Reported as:
Least squares mean · Probability
Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form
ProbabilityMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
1 month post-release from incarceration.63 ± .08.56 ± .09.26 ± .08
3 months post-release from incarceration.57 ± .08.47 ± .09.19 ± .07
6 months post-release from incarceration.52 ± .09.52 ± .09.24 ± .07
12 months post-release from incarceration.40 ± .09.27 ± .09.29 ± .08
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .10
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = .74
SecondaryMean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI)

Mean number of days reported by participants of their criminal activity during the 30 days preceding the Addiction Severity Index interviews

Time frame:
1, 3, 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · Days
Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI)
DaysMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
1 month post-release from incarceration5.22 ± 1.298.18 ± 1.748.22 ± 2.15
3 months post-release from incarceration9.79 ± 1.819.35 ± 1.6610.59 ± 2.15
6 months post-release from incarceration9.24 ± 1.889.74 ± 1.8911.49 ± 1.99
12 months post-release from incarceration6.88 ± 1.549.97 ± 1.8810.18 ± 1.99
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .42
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 0.42
SecondaryMean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days

Mean number of participant self-reported days of heroin use in the 30 days preceding the interview on the Addiction Severity Index (ASI)

Time frame:
1, 3, 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · Days
Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days
DaysMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
1 month post-release from incarceration8.66 ± 1.3212.07 ± 1.7214.88 ± 2.12
3 months post-release from incarceration13.46 ± 1.8415.15 ± 1.8416.18 ± 2.04
6 months post-release from incarceration13.56 ± 1.8314.02 ± 1.9015.42 ± 1.90
12 months post-release from incarceration12.35 ± 1.6614.70 ± 1.8215.35 ± 1.90
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .28
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 0.44
SecondaryParticipant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days

Participant self-reported mean number of days of cocaine use in the 30 days preceding the interview on the Addiction Severity Index (ASI)

Time frame:
1, 3, 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · Days
Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days
DaysMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
1 month post-release from incarceration5.95 ± 1.299.05 ± 1.7311.01 ± 2.10
3 months post-release from incarceration8.83 ± 1.7111.32 ± 1.9311.94 ± 2.14
6 months post-release from incarceration10.74 ± 1.8613.57 ± 2.2311.94 ± 2.14
12 months post-release from incarceration9.60 ± 1.7014.46 ± 2.1912.63 ± 2.01
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .61
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = 0.72
SecondaryPredicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days

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).

Time frame:
3, 6, and 12 months post-release from incarceration
Reported as:
Least squares mean · Probability
Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days
ProbabilityMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
3 months post-release from incarceration.20 ± .08.32 ± .011.32 ± .12
6 months post-release from incarceration.22 ± .10.35 ± .12.36 ± .14
12 months post-release from incarceration.32 ± .15.40 ± .20.30 ± .14
Statistical analysis
  • Methadone Plus Patient Navigation vs Methadone vs Enhanced Treatment as Usual · Generalized Linear Mixed Model Analysis · p = .71
  • Methadone Plus Patient Navigation vs Methadone · Generalized Linear Mixed Model Analysis · p = .86
SecondaryDays of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90)

Mean number of days hospitalized during the 12 months post-release from incarceration

Time frame:
12 months post-release from incarceration
Reported as:
Mean · Days
Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90)
DaysMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90)2.0 ± 5.83.4 ± 9.71.2 ± 3.1
SecondaryCost of Substance Abuse Services

Cost in US Dollars of substance abuse services on the modified Substance Abuse Services Cost Analysis Program

Time frame:
12 months post-release from incarceration
Reported as:
Mean · US Dollars
Cost of Substance Abuse Services
US DollarsMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Cost of Substance Abuse Services3052 ± 5332377 ± 3511884 ± 292

Adverse events

Collected over 12 months following release from index incarceration. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Methadone Plus Patient Navigation1/75 (1.3%)11/75 (14.7%)3/75 (4%)
Methadone3/74 (4.1%)20/74 (27%)12/74 (16.2%)
Enhanced Treatment as Usual3/76 (3.9%)16/76 (21.1%)12/76 (15.8%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
HospitalizationInjury, poisoning and procedural complications2/752/748/76
HospitalizationInfections and infestations2/757/744/76
HospitalizationPsychiatric disorders1/754/741/76
HospitalizationRespiratory, thoracic and mediastinal disorders2/752/741/76
HospitalizationNervous system disorders2/752/740/76
HospitalizationVascular disorders1/752/740/76
HospitalizationBlood and lymphatic system disorders2/750/740/76
HospitalizationCardiac disorders2/750/740/76
HospitalizationGastrointestinal disorders0/751/740/76
HospitalizationNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/751/740/76
Most frequent other events
Most frequent other events
EventMethadone Plus Patient NavigationMethadoneEnhanced Treatment as Usual
Non fatal overdoseInjury, poisoning and procedural complications3/7512/7412/76

Baseline characteristics

Age, Continuous
Age, Continuous(years)Methadone Plus Patient NavigationMethadoneEnhanced Treatment as UsualTotal
Mean39.6 ± 10.037.3 ± 10.037.9 ± 11.138.3 ± 10.4
Sex: Female, Male
Sex: Female, Male(Participants)Methadone Plus Patient NavigationMethadoneEnhanced Treatment as UsualTotal
Female15141544
Male606061181
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Methadone Plus Patient NavigationMethadoneEnhanced Treatment as UsualTotal
Hispanic or Latino3036
Not Hispanic or Latino727473219
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Methadone Plus Patient NavigationMethadoneEnhanced Treatment as UsualTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American514543139
White17172256
More than one race612927
Unknown or Not Reported1023
Region of Enrollment
Region of Enrollment(Participants)Methadone Plus Patient NavigationMethadoneEnhanced Treatment as UsualTotal
United States757476225
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Study locations

1 site
  • Baltimore City Detention Center
    Baltimore, Maryland 21202, United States
09

References and documents

Publications

  • 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. PubMed 33196937 ↗
  • 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. PubMed 33187759 ↗
  • 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. PubMed 31748939 ↗
  • 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. doi: 10.1016/j.cct.2016.09.008. PubMed 27282117 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 9, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02334215
Lead sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Laura and John Arnold Foundation
Responsible party
Sponsor
First posted
Jan 8, 2015
Start date
Dec 15, 2014
Primary completion
Mar 8, 2019
Completion
May 2020
Results posted
Sep 16, 2020
Last update
Sep 16, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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