New study aims to help pregnant women with opioid addiction get better care and keep families together
NCT ID NCT06956352
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a team-based care model for pregnant and postpartum women with opioid use disorder in low-resource clinics. About 1,350 participants will receive coordinated support to start and stay on medication, reduce overdose risk, and improve well-child visits. The goal is to see if this approach leads to better health for mothers and their children.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A core team of clinical providers at each obstetric site (i.e., nurse case manager, peer navigator, advanced practice provider, behavioral health provider, and lead obstetrician/gynecologist) have already committed to providing clinical care for the adapted CCM and participate in all stages of the research process. As such, they will not need to be recruited for participation. Maternal and child outcome data will be collected retrospectively from the EHR and individual patients will not be recruited to participate in the study. A small subset of pregnant women (n=50) who meet DSM-V criteria for OUD and who receive care at obstetric sites will be recruited for a one-time, semi-structured qualitative interview.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: (Stakeholder Participant) 1. 18 years or older 2. Providing care at participating obstetric site 3. English speaking (Patient Participant) 1. 18 years or older 2. Receiving care at participating obstetric site 3. English speaking Exclusion Criteria: 1\. Unwillingness to have participation audio recorded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise boost brain and body health during opioid treatment?
- How much lidocaine reaches a newborn during an urgent C-Section?
- Can a new drug calm the storm of opioid withdrawal?
- Could pregnant patients skip clinic visits and monitor their baby from home?
- Could a pill replace daily shots for clot prevention after C-Section?
- Can a video session get pregnant women to seek more health care?