Opioid Use DisorderSOMATICS FRINCT02334215
A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
A study testing Methadone, Patient Navigation and Enhanced Treatment as Usual (ETAU) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Methadone, Patient Navigation and Enhanced Treatment as Usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2014to May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore City Detention Center
Baltimore, Maryland, 21202
About this study
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:
- 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:
- Illicit Opioid use: measured by urine drug testing results at 6 months post-release
- Number of days incarcerated: Measured by self-report during the 6 months post-release.
- HIV risk behavior: Measured by self-report (Drug Risk Assessment Battery [RAB] Needle Use score) at the 6-month post-release follow-up assessment.
- 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).
- Non-opioid drug use (Cocaine, Amphetamines, and Benzodiazepines): measured by urine drug testing at 6 months post-release
- Number of days in any drug abuse treatment: Measured by self-report at 6 months post-release.
- Number of arrests: Measured by self-report data collected at 6 months post-release.
- Craving scores (for NYU and UCLA sites only): Measured by self-report craving scale at 6 months post-release.
- Non-lethal overdose (Yes/No): Measured by self-report during the 6 months post-release.
- Lethal overdose (Yes/No): Measured by public records data reviewed at 6 months post-release.
- WHO Quality of Life-BREF (WHOQOL-BREF) score: Measured by self-report at 6 months post-release.
- Analyses of above self-same outcomes at 12 months follow-up.
- 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Methadone, Patient Navigation, Enhanced Treatment as Usual (ETAU)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.
Patient NavigationBehavioural
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.
Enhanced Treatment as Usual (ETAU)Behavioural
Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community.
| Study group | Role | What they receive |
|---|---|---|
| Methadone plus Patient Navigation | Experimental | Participants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention. Receives: Drug: Methadone; Behavioral: Patient Navigation |
| Methadone | Experimental | Participants will begin methadone during detention. Receives: Drug: Methadone |
| Enhanced Treatment as Usual | Active comparator | Participants will receive opioid detoxification during detention, as well as drug abuse education, overdose prevention education, and referral to drug abuse treatment and overdose prevention services in the community. Receives: Behavioral: Enhanced Treatment as Usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1, 3, 6, and 12 months post-release from incarceration
Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form
Predicted probability derived from the general linear mixed model of self-reported entry into treatment for opioid use disorder following release from incarceration and being in treatment 30 days post-release (0= no entry in treatment; 1= entry in treatment).
Measured: 30 days post-release from incarceration
Secondary outcomes (16)
Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)
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).
Measured: one month period prior to the 3, 6, and 12 month post-release from incarceration
Number of Participants With Arrests
Official data on participant arrests subsequent to release from index incarceration.
Measured: one year post-release from incarceration
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
Measured: Baseline and 6, and 12 months post-release from incarceration
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.
Measured: Baseline and 6, and 12 months post-release from incarceration
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.
Measured: 1, 3, 6, and 12 months post-incarceration
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.
Measured: 1, 3, 6, and 12 months post-release from incarceration
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.
Measured: 1, 3, 6, and 12 month post-release from incarceration
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.
Measured: 1, 3, 6, and 12 months post-release from incarceration
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.
Measured: 1, 3, 6, and 12 month post-release from incarceration
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).
Measured: 12 months post-release from incarceration
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
Measured: 1, 3, 6, and 12 months post-release from incarceration
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)
Measured: 1, 3, 6, and 12 months post-release from incarceration
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)
Measured: 1, 3, 6, and 12 months post-release from incarceration
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).
Measured: 3, 6, and 12 months post-release from incarceration
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
Measured: 12 months post-release from incarceration
Cost of Substance Abuse Services
Cost in US Dollars of substance abuse services on the modified Substance Abuse Services Cost Analysis Program
Measured: 12 months post-release from incarceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study start15 Dec 2014
- Primary completion8 Mar 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Laura and John Arnold Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334215
- Sponsor's protocol ID
- 3U01DA013636
- Other IDs
- 3U01DA013636
- Acronym
- SOMATICS FRI
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2014
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 33196937Schwartz 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 33187759Mitchell 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 31748939Schwartz 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.
PubMed 27282117
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Interim Methadone and Patient Navigation Initiated in Jail
- ClinicalTrials.gov ID
- NCT02334215
- Acronym / sponsor ID
- SOMATICS FRI / 3U01DA013636
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Laura and John Arnold Foundation
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Illicit Opioid use: measured by urine drug testing results at 6 months post-release
- Number of days incarcerated: Measured by self-report during the 6 months post-release.
- HIV risk behavior: Measured by self-report (Drug Risk Assessment Battery [RAB] Needle Use score) at the 6-month post-release follow-up assessment.
- 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).
- Non-opioid drug use (Cocaine, Amphetamines, and Benzodiazepines): measured by urine drug testing at 6 months post-release
- Number of days in any drug abuse treatment: Measured by self-report at 6 months post-release.
- Number of arrests: Measured by self-report data collected at 6 months post-release.
- Craving scores (for NYU and UCLA sites only): Measured by self-report craving scale at 6 months post-release.
- Non-lethal overdose (Yes/No): Measured by self-report during the 6 months post-release.
- Lethal overdose (Yes/No): Measured by public records data reviewed at 6 months post-release.
- WHO Quality of Life-BREF (WHOQOL-BREF) score: Measured by self-report at 6 months post-release.
- Analyses of above self-same outcomes at 12 months follow-up.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methadone plus Patient Navigation | Experimental | Drug: Methadone, Behavioral: Patient NavigationParticipants will begin methadone treatment during detention and will have a patient navigator for up to 3 months post-release from detention. |
| Methadone | Experimental | Drug: MethadoneParticipants will begin methadone during detention. |
| Enhanced Treatment as Usual | Active comparator | Behavioral: Enhanced Treatment as Usual (ETAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneInterim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community. | Drug | Methadone, Methadone plus Patient Navigation |
| Patient NavigationA 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. | Behavioural | Methadone plus Patient Navigation |
| 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. | Behavioural | Enhanced Treatment as Usual |
Primary outcome
Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time
Time frame: 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
Time frame: 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).
16 secondary outcomes
Predicted Probability Derived From Generalized Linear Mixed Model of Meeting Opioid Use Disorder Criteria as Determined by the Modified Composite International Diagnostic Interview (CIDI)
Time frame: one month period prior to the 3, 6, and 12 month post-release from incarceration
Number of Participants With Arrests
Time frame: one year post-release from incarceration
Drug Risk Score on the Risk Assessment Battery (RAB)
Time frame: Baseline and 6, and 12 months post-release from incarceration
Sex Risk Score on the Risk Assessment Battery (RAB)
Time frame: Baseline and 6, and 12 months post-release from incarceration
Physical Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: 1, 3, 6, and 12 months post-incarceration
Psychological Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: 1, 3, 6, and 12 months post-release from incarceration
Social Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: 1, 3, 6, and 12 month post-release from incarceration
Environmental Domain Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: 1, 3, 6, and 12 months post-release from incarceration
Overall Quality of Life Score on the World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: 1, 3, 6, and 12 month post-release from incarceration
Predicted Probability Derived From the Generalized Linear Mixed Model of Being Retained in Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form
Time frame: 12 months post-release from incarceration
Mean Number of Days of Criminal Activity in the Past 30 Days Reported by Participants on the Addiction Severity Index (ASI)
Time frame: 1, 3, 6, and 12 months post-release from incarceration
Mean Number of Days of Illicit Opioid Use Reported by Participants in the Past 30 Days
Time frame: 1, 3, 6, and 12 months post-release from incarceration
Participant Self-reported Mean Number of Days of Cocaine Use in the Past 30 Days
Time frame: 1, 3, 6, and 12 months post-release from incarceration
Predicted Probability Derived From the Generalized Linear Mixed Model of Meeting Cocaine Use Disorder Criteria in the Past 30 Days
Time frame: 3, 6, and 12 months post-release from incarceration
Days of Hospitalization (Health Care Utilization) on the Economic Form 90 (EF-90)
Time frame: 12 months post-release from incarceration
Cost of Substance Abuse Services
Time frame: 12 months post-release from incarceration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33196937Mitchell 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.
- Derived from this study: PubMed 33187759Schwartz 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.
- Derived from this study: PubMed 31748939Mitchell 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.
- Derived from this study: PubMed 27282117Schwartz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methadone, Patient Navigation and Enhanced Treatment as Usual (ETAU) in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time (time frame: 1, 3, 6, and 12 months post-release from incarceration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02334215, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.