Opioid Use Disorder
Conditions
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.
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.
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Laura and John Arnold Foundation
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 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) |
| Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 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
| Measure | Time frame | Description |
|---|---|---|
| Drug Risk Score on the Risk Assessment Battery (RAB) | 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 |
| Sex 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). Higher scores represents greater risk. The score ranges from 0 to 18. |
| Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 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. |
| Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 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. |
| Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 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. |
| Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 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. |
| Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 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. |
| 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 | 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). |
| Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 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 |
| Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 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) |
| Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 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) |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 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). |
| Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90) | 12 months post-release from incarceration | Mean number of days hospitalized during the 12 months post-release from incarceration |
| Cost of Substance Abuse Services | 12 months post-release from incarceration | Cost in US Dollars of substance abuse services on the modified Substance Abuse Services Cost Analysis Program |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 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). |
| Number of Participants With Arrests | one year post-release from incarceration | Official data on participant arrests subsequent to release from index incarceration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.
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. | 75 |
| Methadone Participants will begin methadone during detention.
Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community. | 74 |
| 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.
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. | 76 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 0 |
| Overall Study | Incarcerated | 0 | 0 | 7 |
| Overall Study | Lost to Follow-up | 1 | 0 | 4 |
| Overall Study | Not released from incarceration on time | 3 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Methadone Plus Patient Navigation | Total | Enhanced Treatment as Usual | Methadone |
|---|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 10 | 38.3 years STANDARD_DEVIATION 10.4 | 37.9 years STANDARD_DEVIATION 11.1 | 37.3 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 219 Participants | 73 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 139 Participants | 43 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 27 Participants | 9 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 56 Participants | 22 Participants | 17 Participants |
| Region of Enrollment United States | 75 Participants | 225 Participants | 76 Participants | 74 Participants |
| Sex: Female, Male Female | 15 Participants | 44 Participants | 15 Participants | 14 Participants |
| Sex: Female, Male Male | 60 Participants | 181 Participants | 61 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 75 | 3 / 74 | 3 / 76 |
| other Total, other adverse events | 3 / 75 | 12 / 74 | 12 / 76 |
| serious Total, serious adverse events | 11 / 75 | 20 / 74 | 16 / 76 |
Outcome results
Primary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, incarcerated individuals who were not drug tested, people interviewed by phone because they no longer lived in the area).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 1 month post-release from incarceration | 0.70 Probability | Standard Error 0.08 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 3 months post-release from incarceration | 0.59 Probability | Standard Error 0.08 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 6 months post-release from incarceration | 0.49 Probability | Standard Error 0.09 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 12 months post-release from incarceration | 0.46 Probability | Standard Error 0.08 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 12 months post-release from incarceration | 0.71 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 1 month post-release from incarceration | 0.72 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 6 months post-release from incarceration | 0.63 Probability | Standard Error 0.1 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 3 months post-release from incarceration | 0.72 Probability | Standard Error 0.09 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 12 months post-release from incarceration | 0.59 Probability | Standard Error 0.09 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 3 months post-release from incarceration | 0.73 Probability | Standard Error 0.08 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 6 months post-release from incarceration | 0.71 Probability | Standard Error 0.08 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | 1 month post-release from incarceration | 0.66 Probability | Standard Error 0.09 |
Comparison: Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usualp-value: 0.32Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.32Generalized Linear Mixed Model Analysis
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Methadone Plus Patient Navigation | 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 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 0.62 Probability | Standard Error 0.1 |
| Enhanced 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 Form | 0.225 Probability | Standard Error 0.09 |
Comparison: Contrast of Interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual Conditionsp-value: 0.001Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usualp-value: 0.84Generalized Linear Mixed Model Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methadone Plus Patient Navigation | Cost of Substance Abuse Services | 3052 US Dollars | Standard Deviation 533 |
| Methadone | Cost of Substance Abuse Services | 2377 US Dollars | Standard Deviation 351 |
| Enhanced Treatment as Usual | Cost of Substance Abuse Services | 1884 US Dollars | Standard Deviation 292 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methadone Plus Patient Navigation | Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90) | 2.0 Days | Standard Deviation 5.8 |
| Methadone | Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90) | 3.4 Days | Standard Deviation 9.7 |
| Enhanced Treatment as Usual | Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90) | 1.2 Days | Standard Deviation 3.1 |
Secondary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 6 months prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Drug Risk Score on the Risk Assessment Battery (RAB) | 6 month post-release from incarceration | 1.52 score on a scale | Standard Error 0.52 |
| Methadone Plus Patient Navigation | Drug Risk Score on the Risk Assessment Battery (RAB) | Baseline | 2.30 score on a scale | Standard Error 0.57 |
| Methadone Plus Patient Navigation | Drug Risk Score on the Risk Assessment Battery (RAB) | 12 month post-release | .50 score on a scale | Standard Error 0.25 |
| Methadone | Drug Risk Score on the Risk Assessment Battery (RAB) | 6 month post-release from incarceration | 1.81 score on a scale | Standard Error 0.65 |
| Methadone | Drug Risk Score on the Risk Assessment Battery (RAB) | Baseline | 2.43 score on a scale | Standard Error 0.62 |
| Methadone | Drug Risk Score on the Risk Assessment Battery (RAB) | 12 month post-release | 1.35 score on a scale | Standard Error 0.59 |
| Enhanced Treatment as Usual | Drug Risk Score on the Risk Assessment Battery (RAB) | Baseline | 3.11 score on a scale | Standard Error 0.76 |
| Enhanced Treatment as Usual | Drug Risk Score on the Risk Assessment Battery (RAB) | 12 month post-release | 1.03 score on a scale | Standard Error 0.44 |
| Enhanced Treatment as Usual | Drug Risk Score on the Risk Assessment Battery (RAB) | 6 month post-release from incarceration | 2.16 score on a scale | Standard Error 0.73 |
Comparison: Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usualp-value: 0.997Generalized Linear Mixed Model
Comparison: Contrast of interest: Methadone plus Patient Navigation vs Methadonep-value: 0.26Generalized Linear Mixed Model Analysis
Secondary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 4 weeks prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 59.0 score on a scale | Standard Error 3.3 |
| Methadone Plus Patient Navigation | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 51.9 score on a scale | Standard Error 3.2 |
| Methadone Plus Patient Navigation | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 48.0 score on a scale | Standard Error 3 |
| Methadone Plus Patient Navigation | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 months post-release from incarceration | 56.1 score on a scale | Standard Error 2.9 |
| Methadone Plus Patient Navigation | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 54.8 score on a scale | Standard Error 3.2 |
| Methadone | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 55.1 score on a scale | Standard Error 3.2 |
| Methadone | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 54.6 score on a scale | Standard Error 3.1 |
| Methadone | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 months post-release from incarceration | 63.6 score on a scale | Standard Error 3.3 |
| Methadone | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 60.6 score on a scale | Standard Error 3.4 |
| Methadone | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 59.4 score on a scale | Standard Error 3.4 |
| Enhanced Treatment as Usual | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 59.3 score on a scale | Standard Error 3.3 |
| Enhanced Treatment as Usual | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 57.2 score on a scale | Standard Error 3.2 |
| Enhanced Treatment as Usual | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 54.9 score on a scale | Standard Error 3 |
| Enhanced Treatment as Usual | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 63.7 score on a scale | Standard Error 3.3 |
| Enhanced Treatment as Usual | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 months post-release from incarceration | 65.1 score on a scale | Standard Error 3.3 |
Comparison: Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usualp-value: 0.013Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.71Generalized Linear Mixed Model Analysis
Secondary
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
Population: Participants who completed at least one follow-up interview following release from index incarceration
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 12 months post-release from incarceration | 6.88 Days | Standard Error 1.54 |
| Methadone Plus Patient Navigation | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 3 months post-release from incarceration | 9.79 Days | Standard Error 1.81 |
| Methadone Plus Patient Navigation | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 1 month post-release from incarceration | 5.22 Days | Standard Error 1.29 |
| Methadone Plus Patient Navigation | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 6 months post-release from incarceration | 9.24 Days | Standard Error 1.88 |
| Methadone | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 12 months post-release from incarceration | 9.97 Days | Standard Error 1.88 |
| Methadone | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 6 months post-release from incarceration | 9.74 Days | Standard Error 1.89 |
| Methadone | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 3 months post-release from incarceration | 9.35 Days | Standard Error 1.66 |
| Methadone | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 1 month post-release from incarceration | 8.18 Days | Standard Error 1.74 |
| Enhanced Treatment as Usual | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 6 months post-release from incarceration | 11.49 Days | Standard Error 1.99 |
| Enhanced Treatment as Usual | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 3 months post-release from incarceration | 10.59 Days | Standard Error 2.15 |
| Enhanced Treatment as Usual | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 1 month post-release from incarceration | 8.22 Days | Standard Error 2.15 |
| Enhanced Treatment as Usual | Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI) | 12 months post-release from incarceration | 10.18 Days | Standard Error 1.99 |
p-value: 0.42Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.42Generalized Linear Mixed Model Analysis
Secondary
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
Population: Participants who were interviewed at least once following release from index incarceration.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 1 month post-release from incarceration | 8.66 Days | Standard Error 1.32 |
| Methadone Plus Patient Navigation | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 3 months post-release from incarceration | 13.46 Days | Standard Error 1.84 |
| Methadone Plus Patient Navigation | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 6 months post-release from incarceration | 13.56 Days | Standard Error 1.83 |
| Methadone Plus Patient Navigation | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 12 months post-release from incarceration | 12.35 Days | Standard Error 1.66 |
| Methadone | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 12 months post-release from incarceration | 14.70 Days | Standard Error 1.82 |
| Methadone | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 1 month post-release from incarceration | 12.07 Days | Standard Error 1.72 |
| Methadone | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 6 months post-release from incarceration | 14.02 Days | Standard Error 1.9 |
| Methadone | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 3 months post-release from incarceration | 15.15 Days | Standard Error 1.84 |
| Enhanced Treatment as Usual | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 12 months post-release from incarceration | 15.35 Days | Standard Error 1.9 |
| Enhanced Treatment as Usual | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 3 months post-release from incarceration | 16.18 Days | Standard Error 2.04 |
| Enhanced Treatment as Usual | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 6 months post-release from incarceration | 15.42 Days | Standard Error 1.9 |
| Enhanced Treatment as Usual | Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days | 1 month post-release from incarceration | 14.88 Days | Standard Error 2.12 |
p-value: 0.28Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.44Generalized Linear Mixed Model Analysis
Secondary
Number of Participants With Arrests
Official data on participant arrests subsequent to release from index incarceration.
Time frame: one year post-release from incarceration
Population: Data presented on the subset of those participants who were released from index incarceration during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methadone Plus Patient Navigation | Number of Participants With Arrests | 32 Participants |
| Methadone | Number of Participants With Arrests | 39 Participants |
| Enhanced Treatment as Usual | Number of Participants With Arrests | 36 Participants |
p-value: 0.55Regression, Logistic
Comparison: Contrast of interest: Methadone plus Patient Navigation vs Methadonep-value: 0.57Regression, Logistic
Secondary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 4 weeks prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 3.51 units on a scale | Standard Error 0.17 |
| Methadone Plus Patient Navigation | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 3.15 units on a scale | Standard Error 0.17 |
| Methadone Plus Patient Navigation | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 2.7 units on a scale | Standard Error 1.6 |
| Methadone Plus Patient Navigation | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 3.49 units on a scale | Standard Error 0.162 |
| Methadone Plus Patient Navigation | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 3.29 units on a scale | Standard Error 0.17 |
| Methadone | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 3.46 units on a scale | Standard Error 0.17 |
| Methadone | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 2.8 units on a scale | Standard Error 0.16 |
| Methadone | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 3.56 units on a scale | Standard Error 0.19 |
| Methadone | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 3.58 units on a scale | Standard Error 0.18 |
| Methadone | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 3.43 units on a scale | Standard Error 0.18 |
| Enhanced Treatment as Usual | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 3.45 units on a scale | Standard Error 0.17 |
| Enhanced Treatment as Usual | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 3.53 units on a scale | Standard Error 0.17 |
| Enhanced Treatment as Usual | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 3.1 units on a scale | Standard Error 0.16 |
| Enhanced Treatment as Usual | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 3.57 units on a scale | Standard Error 0.17 |
| Enhanced Treatment as Usual | Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 3.40 units on a scale | Standard Error 0.19 |
p-value: 0.32Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.85Generalized Linear Mixed Model Analysis
Secondary
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
Population: Participants who were interviewed at least once following release from index incarceration
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 1 month post-release from incarceration | 5.95 Days | Standard Error 1.29 |
| Methadone Plus Patient Navigation | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 3 months post-release from incarceration | 8.83 Days | Standard Error 1.71 |
| Methadone Plus Patient Navigation | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 6 months post-release from incarceration | 10.74 Days | Standard Error 1.86 |
| Methadone Plus Patient Navigation | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 12 months post-release from incarceration | 9.60 Days | Standard Error 1.7 |
| Methadone | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 12 months post-release from incarceration | 14.46 Days | Standard Error 2.19 |
| Methadone | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 1 month post-release from incarceration | 9.05 Days | Standard Error 1.73 |
| Methadone | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 6 months post-release from incarceration | 13.57 Days | Standard Error 2.23 |
| Methadone | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 3 months post-release from incarceration | 11.32 Days | Standard Error 1.93 |
| Enhanced Treatment as Usual | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 12 months post-release from incarceration | 12.63 Days | Standard Error 2.01 |
| Enhanced Treatment as Usual | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 3 months post-release from incarceration | 11.94 Days | Standard Error 2.14 |
| Enhanced Treatment as Usual | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 6 months post-release from incarceration | 11.94 Days | Standard Error 2.14 |
| Enhanced Treatment as Usual | Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days | 1 month post-release from incarceration | 11.01 Days | Standard Error 2.1 |
Comparison: Contrast of interest: Methadone plus Patient Navigation and Methadone combined vs. Enhanced Treatment as Usualp-value: 0.61Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.72Generalized Linear Mixed Model Analysis
Secondary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 4 weeks prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 68.6 score on a scale | Standard Error 3.1 |
| Methadone Plus Patient Navigation | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 60.3 score on a scale | Standard Error 3.1 |
| Methadone Plus Patient Navigation | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 54.6 score on a scale | Standard Error 2.8 |
| Methadone Plus Patient Navigation | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 months post-release from incarceration | 62.8 score on a scale | Standard Error 3 |
| Methadone Plus Patient Navigation | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 63.1 score on a scale | Standard Error 3 |
| Methadone | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 60.1 score on a scale | Standard Error 3.1 |
| Methadone | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 58.3 score on a scale | Standard Error 3 |
| Methadone | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 months post-release from incarceration | 62.2 score on a scale | Standard Error 3.4 |
| Methadone | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 66.3 score on a scale | Standard Error 3.2 |
| Methadone | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 63.8 score on a scale | Standard Error 3.2 |
| Enhanced Treatment as Usual | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 60.3 score on a scale | Standard Error 3 |
| Enhanced Treatment as Usual | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 61.2 score on a scale | Standard Error 3 |
| Enhanced Treatment as Usual | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 57.1 score on a scale | Standard Error 2.8 |
| Enhanced Treatment as Usual | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 67.3 score on a scale | Standard Error 3.2 |
| Enhanced Treatment as Usual | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 months post-release from incarceration | 68.7 score on a scale | Standard Error 3.4 |
Comparison: Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usualp-value: 0.007Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.76Generalized Linear Mixed Model Analysis
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)
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 30 days prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 6 months post-release from incarceration | 0.51 Probability | Standard Error 0.09 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 3 months post-release from incarceration | 0.66 Probability | Standard Error 0.09 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 12 months post-release from incarceration | 0.54 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 6 months post-release from incarceration | 0.59 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 3 months post-release from incarceration | 0.70 Probability | Standard Error 0.08 |
| Methadone | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 12 months post-release from incarceration | 0.77 Probability | Standard Error 0.11 |
| Enhanced Treatment as Usual | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 3 months post-release from incarceration | 0.76 Probability | Standard Error 0.08 |
| Enhanced Treatment as Usual | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 12 months post-release from incarceration | 0.59 Probability | Standard Error 0.09 |
| Enhanced Treatment as Usual | Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI) | 6 months post-release from incarceration | 0.77 Probability | Standard Error 0.08 |
Comparison: Contrast of interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usualp-value: 0.11Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.55Generalized Linear Mixed Model Analysis
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
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
Population: Participants who had completed at least one follow-up interview.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 1 month post-release from incarceration | .63 Probability | Standard Error 0.08 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 3 months post-release from incarceration | .57 Probability | Standard Error 0.08 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 6 months post-release from incarceration | .52 Probability | Standard Error 0.09 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 12 months post-release from incarceration | .40 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 12 months post-release from incarceration | .27 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 1 month post-release from incarceration | .56 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 6 months post-release from incarceration | .52 Probability | Standard Error 0.09 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 3 months post-release from incarceration | .47 Probability | Standard Error 0.09 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 12 months post-release from incarceration | .29 Probability | Standard Error 0.08 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 3 months post-release from incarceration | .19 Probability | Standard Error 0.07 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 6 months post-release from incarceration | .24 Probability | Standard Error 0.07 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form | 1 month post-release from incarceration | .26 Probability | Standard Error 0.08 |
p-value: 0.1Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.74Generalized Linear Mixed Model Analysis
Secondary
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
Population: Participants who completed at least one interview following release from index incarceration
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 6 months post-release from incarceration | .22 Probability | Standard Error 0.1 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 3 months post-release from incarceration | .20 Probability | Standard Error 0.08 |
| Methadone Plus Patient Navigation | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 12 months post-release from incarceration | .32 Probability | Standard Error 0.15 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 6 months post-release from incarceration | .35 Probability | Standard Error 0.12 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 3 months post-release from incarceration | .32 Probability | Standard Error 0.011 |
| Methadone | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 12 months post-release from incarceration | .40 Probability | Standard Error 0.2 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 3 months post-release from incarceration | .32 Probability | Standard Error 0.12 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 12 months post-release from incarceration | .30 Probability | Standard Error 0.14 |
| Enhanced Treatment as Usual | Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days | 6 months post-release from incarceration | .36 Probability | Standard Error 0.14 |
p-value: 0.71Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.86Generalized Linear Mixed Model Analysis
Secondary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 4 weeks prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 64.9 score on a scale | Standard Error 3.5 |
| Methadone Plus Patient Navigation | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 62.6 score on a scale | Standard Error 3.4 |
| Methadone Plus Patient Navigation | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 56.8 score on a scale | Standard Error 2.8 |
| Methadone Plus Patient Navigation | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 65.5 score on a scale | Standard Error 3.1 |
| Methadone Plus Patient Navigation | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 62.0 score on a scale | Standard Error 3.2 |
| Methadone | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 61.2 score on a scale | Standard Error 3.3 |
| Methadone | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 56.9 score on a scale | Standard Error 3 |
| Methadone | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 64.0 score on a scale | Standard Error 3.5 |
| Methadone | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 63.9 score on a scale | Standard Error 3.6 |
| Methadone | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 61.8 score on a scale | Standard Error 3.4 |
| Enhanced Treatment as Usual | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 64.4 score on a scale | Standard Error 3.3 |
| Enhanced Treatment as Usual | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 64.8 score on a scale | Standard Error 3.4 |
| Enhanced Treatment as Usual | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 55.9 score on a scale | Standard Error 3 |
| Enhanced Treatment as Usual | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 66.6 score on a scale | Standard Error 3.4 |
| Enhanced Treatment as Usual | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 66.7 score on a scale | Standard Error 3.5 |
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usualp-value: 0.6Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 1Generalized Linear Mixed Model Analysis
Secondary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 6 months prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Sex Risk Score on the Risk Assessment Battery (RAB) | 6 months post-release | 3.93 score on a scale | Standard Error 0.34 |
| Methadone Plus Patient Navigation | Sex Risk Score on the Risk Assessment Battery (RAB) | Baseline | 4.52 score on a scale | Standard Error 0.34 |
| Methadone Plus Patient Navigation | Sex Risk Score on the Risk Assessment Battery (RAB) | 12 month post-release | 3.78 score on a scale | Standard Error 0.36 |
| Methadone | Sex Risk Score on the Risk Assessment Battery (RAB) | 6 months post-release | 3.94 score on a scale | Standard Error 0.35 |
| Methadone | Sex Risk Score on the Risk Assessment Battery (RAB) | Baseline | 4.78 score on a scale | Standard Error 0.35 |
| Methadone | Sex Risk Score on the Risk Assessment Battery (RAB) | 12 month post-release | 4.61 score on a scale | Standard Error 0.42 |
| Enhanced Treatment as Usual | Sex Risk Score on the Risk Assessment Battery (RAB) | Baseline | 4.68 score on a scale | Standard Error 0.34 |
| Enhanced Treatment as Usual | Sex Risk Score on the Risk Assessment Battery (RAB) | 12 month post-release | 4.17 score on a scale | Standard Error 0.38 |
| Enhanced Treatment as Usual | Sex Risk Score on the Risk Assessment Battery (RAB) | 6 months post-release | 4.27 score on a scale | Standard Error 0.36 |
p-value: 0.663Generalized Linear Mixed Model
Comparison: Contrast of interest: Methadone plus Patient Navigation vs Methadonep-value: 0.33Generalized Linear Mixed Model Analysis
Secondary
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
Population: The number analyzed at the follow-up points differ due to missing data (e.g., lost to follow-up, people who were incarcerated during the 4 weeks prior to the interview).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Methadone Plus Patient Navigation | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 63.3 score on a scale | Standard Error 3.8 |
| Methadone Plus Patient Navigation | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 60.9 score on a scale | Standard Error 4.1 |
| Methadone Plus Patient Navigation | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 56.9 score on a scale | Standard Error 3.9 |
| Methadone Plus Patient Navigation | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 63.6 score on a scale | Standard Error 3.9 |
| Methadone Plus Patient Navigation | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 56.6 score on a scale | Standard Error 4.3 |
| Methadone | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 62.4 score on a scale | Standard Error 4 |
| Methadone | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 57.7 score on a scale | Standard Error 4 |
| Methadone | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 57.5 score on a scale | Standard Error 4.4 |
| Methadone | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 63.3 score on a scale | Standard Error 3.9 |
| Methadone | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 55.4 score on a scale | Standard Error 4.5 |
| Enhanced Treatment as Usual | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 12 months post-release from incarceration | 59.1 score on a scale | Standard Error 4.3 |
| Enhanced Treatment as Usual | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 6 months post-release from incarceration | 58.8 score on a scale | Standard Error 3.7 |
| Enhanced Treatment as Usual | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | Baseline | 51.3 score on a scale | Standard Error 3.9 |
| Enhanced Treatment as Usual | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 3 months post-release from incarceration | 66.4 score on a scale | Standard Error 4.1 |
| Enhanced Treatment as Usual | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1 month post-release from incarceration | 64.9 score on a scale | Standard Error 4.4 |
Comparison: Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usualp-value: 0.09Generalized Linear Mixed Model Analysis
Comparison: Contrast of interest: Methadone plus Patient Navigation vs. Methadonep-value: 0.74Generalized Linear Mixed Model Analysis