Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Optimizing Pregnancy Care with Patient Navigation for Moms on Opioid Surgery?

Official title: Randomized Trial: Optimizing Pregnancy and Treatment Interventions for Moms (OPTI-Mom) 3.0

Run by University of Utah · NCT07586917 · Data updated 2026-11-12

We’re testing whether patient navigation helps pregnant Medicaid members with opioid (and possibly stimulant) use disorders stay in care, use available medications, and connect with services better than usual care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment429 (estimated)
SponsorUniversity of Utah
Academic / other
Locations1 site (Salt Lake City, Utah)
StatusRecruiting
StartedJuly 10, 2026
Main results expectedJune 2029
Study endsJune 2030
Registry record updatedJuly 16, 2026
Trial IDNCT07586917 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults ≥18 years with opioid use disorder, at least 7 weeks pregnant, and either MOUD-naive or recently started, who can provide access to care records and has English proficiency.

Probably not a fit

Individuals unable to engage with telephone or video visits, or planning to move away before delivery, may see limited benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study compares Patient Navigation to Usual Care for pregnant and postpartum individuals with opioid use disorder. Participants are assigned by chance to receive dedicated navigators who offer 14 sessions over up to 14 months and three surveys, all reachable by phone or video. The goal is to improve retention in care, medication use for opioid use disorder, and access to supportive services, addressing social and logistical barriers. MOUD is part of standard care, while there is no FDA-approved medication for stimulant use disorder, making integrated approaches particularly important. The trial is conducted at the University of Utah and targets English-speaking adults 18 and older who are ≥7 weeks pregnant and on MOUD or newly initiating MOUD.

Why it matters

Potential benefit: If successful, patients may stay engaged in care, continue MOUD, reduce substance use, and access coordinated services.

How similar studies have gone: Prior models integrating navigation and support have shown promise in improving engagement, though results vary by population and setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • University of Utah
    Salt Lake City, Utah, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.