Trial · NCT02334215
A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
NCT02334215, Not applicable, Completed, Friends Research Institute, Inc.; results first posted 2020-09-16
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ConductScience Library. A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail. Trials, record NCT02334215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02334215
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
- NCT number
- NCT02334215
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 225 participants, actual
- Lead sponsor
- Friends Research Institute, Inc.
- Conditions
- Opioid Use Disorder
- Interventions
- Methadone, Patient Navigation, Enhanced Treatment as Usual (ETAU)
- First posted
- 2015-01-08
- Last updated
- 2020-09-16
- Results first posted
- 2020-09-16
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) |
| Primary | 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 | 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). |
| Secondary | Number of Participants With Arrests | one year post-release from incarceration | Official data on participant arrests subsequent to release from index incarceration. |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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). | Probability | LEAST_SQUARES_MEAN |
| PRIMARY | 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 | Probability | LEAST_SQUARES_MEAN | |
| 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) | one month period prior to the 3, 6, and 12 month post-release from incarceration | 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). | Probability | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Arrests | one year post-release from incarceration | Data presented on the subset of those participants who were released from index incarceration during the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Drug Risk Score on the Risk Assessment Battery (RAB) | Baseline and 6, and 12 months post-release from incarceration | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sex Risk Score on the Risk Assessment Battery (RAB) | Baseline and 6, and 12 months post-release from incarceration | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1, 3, 6, and 12 months post-incarceration | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1, 3, 6, and 12 months post-release from incarceration | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1, 3, 6, and 12 month post-release from incarceration | 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). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF) | 1, 3, 6, and 12 months post-release from incarceration | 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). | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group183
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Methadone Plus Patient Navigation | 1 month post-release from incarceration | 0.70 | Standard Error 0.08 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Methadone | 1 month post-release from incarceration | 0.72 | Standard Error 0.09 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Enhanced Treatment as Usual | 1 month post-release from incarceration | 0.66 | Standard Error 0.09 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Methadone Plus Patient Navigation | 3 months post-release from incarceration | 0.59 | Standard Error 0.08 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Methadone | 3 months post-release from incarceration | 0.72 | Standard Error 0.09 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Enhanced Treatment as Usual | 3 months post-release from incarceration | 0.73 | Standard Error 0.08 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Methadone Plus Patient Navigation | 6 months post-release from incarceration | 0.49 | Standard Error 0.09 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Methadone | 6 months post-release from incarceration | 0.63 | Standard Error 0.10 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Enhanced Treatment as Usual | 6 months post-release from incarceration | 0.71 | Standard Error 0.08 | Probability |
| Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time | Methadone Plus Patient Navigation | 12 months post-release from incarceration | 0.46 | Standard Error 0.08 | Probability |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methadone Plus Patient Navigation | 75 | |
| Overall Study | STARTED | Methadone | 74 | |
| Overall Study | STARTED | Enhanced Treatment as Usual | 76 | |
| Overall Study | COMPLETED | Methadone Plus Patient Navigation | 68 | |
| Overall Study | COMPLETED | Methadone | 68 | |
| Overall Study | COMPLETED | Enhanced Treatment as Usual | 61 | |
| Overall Study | NOT COMPLETED | Methadone Plus Patient Navigation | 7 | |
| Overall Study | NOT COMPLETED | Methadone | 6 | |
| Overall Study | NOT COMPLETED | Enhanced Treatment as Usual | 15 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Non fatal overdose | Injury, poisoning and procedural complications | Methadone Plus Patient Navigation | 3 | 75 | |
| other | Non fatal overdose | Injury, poisoning and procedural complications | Methadone | 12 | 74 | |
| other | Non fatal overdose | Injury, poisoning and procedural complications | Enhanced Treatment as Usual | 12 | 76 | |
| serious | Hospitalization | Hepatobiliary disorders | Methadone Plus Patient Navigation | 0 | 75 | 0 |
| serious | Hospitalization | Hepatobiliary disorders | Methadone | 0 | 74 | 0 |
| serious | Hospitalization | Hepatobiliary disorders | Enhanced Treatment as Usual | 1 | 76 | 1 |
| serious | Hospitalization | Infections and infestations | Methadone Plus Patient Navigation | 2 | 75 | 3 |
| serious | Hospitalization | Infections and infestations | Methadone | 7 | 74 | 10 |
| serious | Hospitalization | Infections and infestations | Enhanced Treatment as Usual | 4 | 76 | 8 |
| serious | Hospitalization | Injury, poisoning and procedural complications | Methadone Plus Patient Navigation | 2 | 75 | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methadone Plus Patient Navigation | 1 | 75 |
| Total, all-cause mortality | Methadone | 3 | 74 |
| Total, all-cause mortality | Enhanced Treatment as Usual | 3 | 76 |
| Total, other adverse events | Methadone Plus Patient Navigation | 3 | 75 |
| Total, other adverse events | Methadone | 12 | 74 |
| Total, other adverse events | Enhanced Treatment as Usual | 12 | 76 |
| Total, serious adverse events | Methadone Plus Patient Navigation | 11 | 75 |
| Total, serious adverse events | Methadone | 20 | 74 |
| Total, serious adverse events | Enhanced Treatment as Usual | 16 | 76 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DA013636 | A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail | SCHWARTZ, ROBERT P | FRIENDS RESEARCH INSTITUTE, INC. | NATIONAL INSTITUTE ON DRUG ABUSE | 2013 to 2016 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02334215
GET https://conductscience.org/api/trials/v1/NCT02334215/results?page=2