Opioid Use DisorderNCT05853289
Piloting a Web Resource for Pregnancy OUD in Jail
A study testing Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in Custody in people with Opioid Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this clinical trial is to pilot an adaptable, user-friendly, web-accessible toolkit and implementation strategy for jails to be able to provide access to pregnancy-specific opioid use disorder (OUD) care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in Custody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- non-English speaking
- Pregnant people with opioid use disorder Inclusion:
- pregnant people with OUD who are in custody at a pilot jail during the study period
- jail stay of at least 24 hours
- non-English speaking
- women who are intoxicated or actively withdrawing
- women are actively psychotic
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: Piloting a Web-Based Implementation Resource for Pregnancy Opioid Use Disorder Care in Jail
The goal of this clinical trial is to pilot an adaptable, user-friendly, web-accessible toolkit and implementation strategy for jails to be able to provide access to pregnancy-specific opioid use disorder (OUD) care. The main question it aims to answer is:
- What support and tools do jails that vary in size, resources, and health care delivery systems need for pregnancy care that can be tailored to the environment?
Read more
Jail staff will use the implementation resource to provide care to pregnant people in and leaving custody through facilitated guidance. While using the resource, jail staff will:
- Complete 6-month and 12-month surveys assessing the participants use of the tool
- Complete baseline, 6-month, and 12-month qualitative interviews assessing the participants perspectives on using the tool
- Report de-identified jail outcomes data monthly on the pregnant people in the jail's care
- Report jail policy and financial data as it pertains to pregnant people with OUD at baseline Pregnant people with OUD in custody at pilot jails will be asked to participate in qualitative interviews as baseline and 1- and 6 months after release to assess the participants perspectives on the care received in jail and continuity of care.
Read the detailed description
Ensuring jails provide access to medications for opioid use disorder (MOUD), and in ways that are tailored to the distinctive medical, mental health and social structural aspects of care for pregnant people with OUD is essential for improving short and long-term pregnancy, recovery, and intergenerational outcomes. This project will engage multiple stakeholders, including directly impacted people, to design then pilot a patient-centered and jail-feasible implementation strategy that will facilitate and enhance jails' implementation of MOUD for pregnant people. The strategy will contain a menu of tools to assist jails with immediate needs to provide MOUD to pregnant people entering jails; with pregnancy-tailored counseling; and with other support services and linkages to care that center the obstetrical, psychosocial, and structural needs of this population. The implementation strategy will also be adaptable to a variety of types and geographies of jails. The strategies will then be piloted at four jails with different baseline capacities and services for MOUD for pregnant people.
Study Design. The investigators will conduct this pilot study to assess feasibility of facilitation of use of a web-based resource bundle to help jail workers be able to implement programs and provide care for pregnant people with OUD (PPwOUD). The investigators will design the bundle and then the research team will train jail staff (clinicians and administrators) at 4 pilot sites on how to use each element of the website-- where things are, and how to adapt it to the local environment. The investigators will then measure implementation outcomes at the jail with staff and with implementing care practices, as well as patient level outcomes.
The investigators will do the pilot sequentially, starting with two jails in cohort A and then, six months later, the two jails in cohort B.The investigators will follow the same procedures at each pair of sites
Pilot sites and champions. The investigators will pilot the resource package at jails with combinations of different geography and availability of MOUD for pregnant people. These strata allows for testing and refinement of the bundle tools to be useful to jails with differing local resources, differing frequencies of encountering pregnant people, and differing stages of providing MOUD for pregnant people. While 3 sites provide MOUD in some capacity in pregnancy, all have self-identified needs for enhancements due to lack of pregnancy specificity and numerous challenges in the care for pregnant people with opioid use disorder (PPwOUD). Pilot site #4, with no MOUD will be recruited through existing networks and, as outlined in support letters, with assistance of Sheriffs from confirmed pilot sites. Each jail will identify 1-2 champions for the implementation effort (e.g. nurse, clinician, social worker, health admin).
Facilitated delivery of the bundle. The implementation strategy of facilitation provides human support to promote self-efficacy, persistence, and problem solving; it is rooted in the notion that implementation is a social activity that reflects interpersonal relationships, learning, and people's decisions in a relational context. The team will adapt the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) facilitation checklist with a blended approach that includes external and internal facilitation. At baseline, the team will conduct in-person or video conference sessions (dependent on jail location) to orient pilot site champions, jail staff and key community partners to the implementation strategy and bundle, followed by monthly video-conference check-ins. Modeling after the Network for the Improvement of Addiction Treatment (NIATx) process improvement model currently being tested at 48 jails. The investigators will deliver well-structured mentoring and technical assistance to jails as to use the bundle to improve care and coordination for pregnant people with OUD. NIATx is an organizational change approach that aims to gauge performance and improve processes by pairing a coach with a site to identify ways to implement change and monitor performance. The investigators will incorporate regularly scheduled outreach to assist, and assess competency of, community partners (e.g. probation, parole, child welfare services, community opioid treatment providers) with justice-involved pregnant populations. The coaching will assist jail leaders and staff to identify local resources, services, agencies, and tools that are relevant for that geographic setting. This focus underlines that toolkits alone have limited impact on implementation outcomes, and successful toolkits benefit from natural internal facilitation.
The intervention is exposing jail staff to a web-based resource that the investigators will design for this study that contains practical, evidence based information on clinical best practices adapted to jail settings for providing medications for OUD for pregnant women in custody AND that contains an implementation strategy for leaders to be able to implement programs.
- Conditions
- Opioid Use Disorder
- Being tested
- Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in Custody
- 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.
Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in CustodyOther
MOM CARE is a web-based implementation resource designed for jail staff to help the staff provide evidence-based, trauma-informed and patient-centered care and support to pregnant people with opioid use disorder in and leaving custody. MOM CARE's content will include medical guidance and best-practices from intake to discharge, reentry steps and recommendations, and implementation 'how to' content. There will be specific content for jail administrators, medical and custody staff. Content will be curated from existing resources regarding this topic with new original tools specific to pregnant people with OUD in jail.
| Study group | Role | What they receive |
|---|---|---|
| Jail staff at pilot jails | Experimental | Jail staff will be asked to use the implementation resource with guided facilitation to care for pregnant people in and leaving custody. Receives: Other: Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in Custody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in organizational readiness as assessed by the ORIC scale
Staff surveys will be administered to assess organizational readiness at baseline before implementation using the organizational readiness for implementing change (ORIC) scale. The scale is a 12-item instrument used to assess how staff at an organization feel they can implement the change in process proposed by an intervention. Each instrument item uses a Likert scale from 1 (disagree) to 5 (agree). A higher score indicates higher organizational readiness.
Measured: Baseline, 6 months, 12 months
Change in technology usage, attitudes and satisfaction as assessed by the UTAUT
Staff interviews will be administered to assess technology usage, attitudes and satisfaction using the unified theory of acceptance and use of technology (UTAUT). The UTAUT uses four constructs to determine user acceptance and usage behavior that include performance expectancy, effort expectancy, social influence and facilitating conditions. UTAUT proposes sub-constructs for each of the 4 categories that we will use to inform the interview guide.
Measured: 6 months, 12 months
Satisfaction, autonomy, discrimination and other experiences for pregnant people with OUD (PPwOUD) in jail as assessed by the RRDS
Mixed methods will be used to assess patient-level outcomes for PPwOUD who are in each jail during the pilot phase. Collecting both quantitative and qualitative data that can be triangulated is necessary to assess health outcomes and experiential dimensions of how the jail's bundle implementation affects patient care in and out of jail. The Recovery-related Discrimination Scale (RRDS) is designed to assess self-reported perceived frequency of personal experiences of slights and violation of personal rights due to their alcohol or drug problems. It includes micro and macro discrimination items that are scored from 'never' to 'often.' The more often the items occurred, the more discrimination the individual experienced. These scale questions will inform the interview guide.
Measured: Post release from jail up to 1 month
Secondary outcomes (2)
Change in financial assessment of caring for PPwOUD in jail
The pilot jail budget reports on costs associated with MOUD care in pregnancy will be used to assess any change between baseline and 12 months.
Measured: Baseline, 12 months
Change in relational coordination as assessed by the Relational Coordination Survey
Staff surveys will be administered at baseline, before implementation, to assess relational coordination using the Relational Coordination (RC) Survey. The survey is a seven-question instrument based on the theory of relational coordination used to assess the impact of relational coordination between staff on desired performance outcomes and assess the impact of individual, organizational, and contextual factors. Jail staff participants will fill this out at baseline, midpoint, and endpoint. Instrument uses a Likert scale from 1 to 5. Scores range from a minimum of 7 to a maximum of 35, with higher scores indicating greater coordination. The results can be calculated as a single Relational Coordination (RC) Index by averaging the responses to all seven questions, or by analyzing scores for each dimension separately.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start14 May 2024
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carolyn Sufrin, MD, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853289
- Sponsor's protocol ID
- IRB00381845
- Other IDs
- 1R34DA056014-01A1
- Status last verified
- Jul 2026
- First submitted
- 2 May 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vilsaint CL, Hoffman LA, Kelly JF. Perceived discrimination in addiction recovery: Assessing the prevalence, nature, and correlates using a novel measure in a U.S. National sample. Drug Alcohol Depend. 2020 Jan 1;206:107667. doi: 10.1016/j.drugalcdep.2019.107667. Epub 2019 Oct 25.
PubMed 31780300Connolly SL, Sullivan JL, Ritchie MJ, Kim B, Miller CJ, Bauer MS. External facilitators' perceptions of internal facilitation skills during implementation of collaborative care for mental health teams: a qualitative analysis informed by the i-PARIHS framework. BMC Health Serv Res. 2020 Mar 4;20(1):165. doi: 10.1186/s12913-020-5011-3.
PubMed 32131824Hunter SC, Kim B, Mudge A, Hall L, Young A, McRae P, Kitson AL. Experiences of using the i-PARIHS framework: a co-designed case study of four multi-site implementation projects. BMC Health Serv Res. 2020 Jun 23;20(1):573. doi: 10.1186/s12913-020-05354-8.
PubMed 32576197Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.
PubMed 24410955Molfenter T, Vechinski J, Taxman FS, Breno AJ, Shaw CC, Perez HA. Fostering MOUD use in justice populations: Assessing the comparative effectiveness of two favored implementation strategies to increase MOUD use. J Subst Abuse Treat. 2021 Sep;128:108370. doi: 10.1016/j.jsat.2021.108370. Epub 2021 Mar 17.
PubMed 33762145
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Web-Based Implementation Resource for Pregnancy Opioid Use Disorder Care in Jail
- ClinicalTrials.gov ID
- NCT05853289
- Acronym / sponsor ID
- IRB00381845
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to pilot an adaptable, user-friendly, web-accessible toolkit and implementation strategy for jails to be able to provide access to pregnancy-specific opioid use disorder (OUD) care. The main question it aims to answer is:
- What support and tools do jails that vary in size, resources, and health care delivery systems need for pregnancy care that can be tailored to the environment?
Jail staff will use the implementation resource to provide care to pregnant people in and leaving custody through facilitated guidance. While using the resource, jail staff will:
- Complete 6-month and 12-month surveys assessing the participants use of the tool
- Complete baseline, 6-month, and 12-month qualitative interviews assessing the participants perspectives on using the tool
- Report de-identified jail outcomes data monthly on the pregnant people in the jail's care
- Report jail policy and financial data as it pertains to pregnant people with OUD at baseline Pregnant people with OUD in custody at pilot jails will be asked to participate in qualitative interviews as baseline and 1- and 6 months after release to assess the participants perspectives on the care received in jail and continuity of care.
Detailed description
Ensuring jails provide access to medications for opioid use disorder (MOUD), and in ways that are tailored to the distinctive medical, mental health and social structural aspects of care for pregnant people with OUD is essential for improving short and long-term pregnancy, recovery, and intergenerational outcomes. This project will engage multiple stakeholders, including directly impacted people, to design then pilot a patient-centered and jail-feasible implementation strategy that will facilitate and enhance jails' implementation of MOUD for pregnant people. The strategy will contain a menu of tools to assist jails with immediate needs to provide MOUD to pregnant people entering jails; with pregnancy-tailored counseling; and with other support services and linkages to care that center the obstetrical, psychosocial, and structural needs of this population. The implementation strategy will also be adaptable to a variety of types and geographies of jails. The strategies will then be piloted at four jails with different baseline capacities and services for MOUD for pregnant people.
Study Design. The investigators will conduct this pilot study to assess feasibility of facilitation of use of a web-based resource bundle to help jail workers be able to implement programs and provide care for pregnant people with OUD (PPwOUD). The investigators will design the bundle and then the research team will train jail staff (clinicians and administrators) at 4 pilot sites on how to use each element of the website-- where things are, and how to adapt it to the local environment. The investigators will then measure implementation outcomes at the jail with staff and with implementing care practices, as well as patient level outcomes.
The investigators will do the pilot sequentially, starting with two jails in cohort A and then, six months later, the two jails in cohort B.The investigators will follow the same procedures at each pair of sites
Pilot sites and champions. The investigators will pilot the resource package at jails with combinations of different geography and availability of MOUD for pregnant people. These strata allows for testing and refinement of the bundle tools to be useful to jails with differing local resources, differing frequencies of encountering pregnant people, and differing stages of providing MOUD for pregnant people. While 3 sites provide MOUD in some capacity in pregnancy, all have self-identified needs for enhancements due to lack of pregnancy specificity and numerous challenges in the care for pregnant people with opioid use disorder (PPwOUD). Pilot site #4, with no MOUD will be recruited through existing networks and, as outlined in support letters, with assistance of Sheriffs from confirmed pilot sites. Each jail will identify 1-2 champions for the implementation effort (e.g. nurse, clinician, social worker, health admin).
Facilitated delivery of the bundle. The implementation strategy of facilitation provides human support to promote self-efficacy, persistence, and problem solving; it is rooted in the notion that implementation is a social activity that reflects interpersonal relationships, learning, and people's decisions in a relational context. The team will adapt the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) facilitation checklist with a blended approach that includes external and internal facilitation. At baseline, the team will conduct in-person or video conference sessions (dependent on jail location) to orient pilot site champions, jail staff and key community partners to the implementation strategy and bundle, followed by monthly video-conference check-ins. Modeling after the Network for the Improvement of Addiction Treatment (NIATx) process improvement model currently being tested at 48 jails. The investigators will deliver well-structured mentoring and technical assistance to jails as to use the bundle to improve care and coordination for pregnant people with OUD. NIATx is an organizational change approach that aims to gauge performance and improve processes by pairing a coach with a site to identify ways to implement change and monitor performance. The investigators will incorporate regularly scheduled outreach to assist, and assess competency of, community partners (e.g. probation, parole, child welfare services, community opioid treatment providers) with justice-involved pregnant populations. The coaching will assist jail leaders and staff to identify local resources, services, agencies, and tools that are relevant for that geographic setting. This focus underlines that toolkits alone have limited impact on implementation outcomes, and successful toolkits benefit from natural internal facilitation.
The intervention is exposing jail staff to a web-based resource that the investigators will design for this study that contains practical, evidence based information on clinical best practices adapted to jail settings for providing medications for OUD for pregnant women in custody AND that contains an implementation strategy for leaders to be able to implement programs.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jail staff at pilot jails | Experimental | Other: Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in CustodyJail staff will be asked to use the implementation resource with guided facilitation to care for pregnant people in and leaving custody. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- non-English speaking
- pregnant people with OUD who are in custody at a pilot jail during the study period
- jail stay of at least 24 hours
- non-English speaking
- women who are intoxicated or actively withdrawing
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 |
|---|---|---|
| Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in CustodyMOM CARE is a web-based implementation resource designed for jail staff to help the staff provide evidence-based, trauma-informed and patient-centered care and support to pregnant people with opioid use disorder in and leaving custody. MOM CARE's content will include medical guidance and best-practices from intake to discharge, reentry steps and recommendations, and implementation 'how to' content. There will be specific content for jail administrators, medical and custody staff. Content will be curated from existing resources regarding this topic with new original tools specific to pregnant people with OUD in jail. | Other | Jail staff at pilot jails |
Primary outcome
Change in organizational readiness as assessed by the ORIC scale
Time frame: Baseline, 6 months, 12 months
Staff surveys will be administered to assess organizational readiness at baseline before implementation using the organizational readiness for implementing change (ORIC) scale. The scale is a 12-item instrument used to assess how staff at an organization feel they can implement the change in process proposed by an intervention. Each instrument item uses a Likert scale from 1 (disagree) to 5 (agree). A higher score indicates higher organizational readiness.
Change in technology usage, attitudes and satisfaction as assessed by the UTAUT
Time frame: 6 months, 12 months
Staff interviews will be administered to assess technology usage, attitudes and satisfaction using the unified theory of acceptance and use of technology (UTAUT). The UTAUT uses four constructs to determine user acceptance and usage behavior that include performance expectancy, effort expectancy, social influence and facilitating conditions. UTAUT proposes sub-constructs for each of the 4 categories that we will use to inform the interview guide.
Satisfaction, autonomy, discrimination and other experiences for pregnant people with OUD (PPwOUD) in jail as assessed by the RRDS
Time frame: Post release from jail up to 1 month
Mixed methods will be used to assess patient-level outcomes for PPwOUD who are in each jail during the pilot phase. Collecting both quantitative and qualitative data that can be triangulated is necessary to assess health outcomes and experiential dimensions of how the jail's bundle implementation affects patient care in and out of jail. The Recovery-related Discrimination Scale (RRDS) is designed to assess self-reported perceived frequency of personal experiences of slights and violation of personal rights due to their alcohol or drug problems. It includes micro and macro discrimination items that are scored from 'never' to 'often.' The more often the items occurred, the more discrimination the individual experienced. These scale questions will inform the interview guide.
2 secondary outcomes
Change in financial assessment of caring for PPwOUD in jail
Time frame: Baseline, 12 months
Change in relational coordination as assessed by the Relational Coordination Survey
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 31780300Vilsaint CL, Hoffman LA, Kelly JF. Perceived discrimination in addiction recovery: Assessing the prevalence, nature, and correlates using a novel measure in a U.S. National sample. Drug Alcohol Depend. 2020 Jan 1;206:107667. doi: 10.1016/j.drugalcdep.2019.107667. Epub 2019 Oct 25.
- Background: PubMed 32131824Connolly SL, Sullivan JL, Ritchie MJ, Kim B, Miller CJ, Bauer MS. External facilitators' perceptions of internal facilitation skills during implementation of collaborative care for mental health teams: a qualitative analysis informed by the i-PARIHS framework. BMC Health Serv Res. 2020 Mar 4;20(1):165. doi: 10.1186/s12913-020-5011-3.
- Background: PubMed 32576197Hunter SC, Kim B, Mudge A, Hall L, Young A, McRae P, Kitson AL. Experiences of using the i-PARIHS framework: a co-designed case study of four multi-site implementation projects. BMC Health Serv Res. 2020 Jun 23;20(1):573. doi: 10.1186/s12913-020-05354-8.
- Background: PubMed 24410955Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.
- Background: PubMed 33762145Molfenter T, Vechinski J, Taxman FS, Breno AJ, Shaw CC, Perez HA. Fostering MOUD use in justice populations: Assessing the comparative effectiveness of two favored implementation strategies to increase MOUD use. J Subst Abuse Treat. 2021 Sep;128:108370. doi: 10.1016/j.jsat.2021.108370. Epub 2021 Mar 17.
- Individual participant dataSharing planned: No
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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.
Carolyn Sufrin, MD, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in Custody in people with Opioid Use Disorder, run by Johns Hopkins University 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 0 inclusion and 7 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 20 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in organizational readiness as assessed by the ORIC scale (time frame: Baseline, 6 months, 12 months). The study lists 3 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 NCT05853289, which also lists 5 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 20 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.