Optimizing Pregnancy and Treatment Interventions for Moms 3.0

This study is looking at whether a program called Patient Navigation can help pregnant individuals with opioid use disorder (OUD), which is a problem with opioid use, and sometimes also stimulant use disorder (StUD), stay in treatment and reduce their substance use. Patient Navigation involves regular sessions with a study navigator. The study aims to see if this approach helps more than usual care. You might be able to join if you are an adult woman (18 or older) who is at least 7 weeks pregnant, has opioid use disorder, and has not recently started medication for opioid use disorder (MOUD). The main goal is to see how much illicit opioid use changes over 36 months. The study is currently unclear on its recruitment status and plans to enroll 429 participants.

Study design
This is an interventional study where participants will be randomly assigned to either receive Patient Navigation or usual care. It plans to enroll 429 participants.
What's involved
If you are in the Patient Navigation group, you may have about 14 sessions/calls (30-45 minutes each) and complete 3 surveys (30-60 minutes each) over up to 14 months. All visits can be by phone or video.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, change in illicit opioid use, is measured at 36 months.

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NCT07586917

Optimizing Pregnancy and Treatment Interventions for Moms 3.0

Recruiting
NAAges 18+InterventionalHealth services
University of Utah
~429 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Patient Navigation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in illicit opioid use
Measured over 36 months
Opioid Abuse (Disorder)
Stimulant Use Disorders
1 sites across 1 states
Utah1
Grace Sr. Clinical Research Coordinator
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Eligibility criteria

Inclusion

Adult (≥18 years)
Opioid use disorder
≥7 weeks gestation
Medication for opioid use disorder naive or newly initiated (≤6 weeks MOUD)
Provide permission to access administrative claims and medical records of their care and those of their neonate
Speak English

Exclusion

Plan to terminate pregnancy
Had a psychotic and/or manic episode in the last 30 days
Cannot provide contact information for themselves and 2 collateral contacts
Do not possess a reliable phone
Plan to move from the area ≤6 months of delivery
\>32 weeks gestation
  • Change in illicit opioid use36 months

    14-panel urine toxicology Timeline Follow Back (TLFB)