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Optimizing Pregnancy and Treatment Interventions for Moms 3.0
Randomized Trial: Optimizing Pregnancy and Treatment Interventions for Moms (OPTI-Mom) 3.0
Who can join
Ages 18 and older · Women
Full eligibility 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
About the study
We want to learn if Patient Navigation helps pregnant Medicaid members with opioid use disorder, with or without stimulant use disorder, stay in care, use medications for opioid use disorder, reduce substance use, and connect with services, compared to usual care.
Enrolled participants will be randomly assigned (by chance, like flipping a coin) to one of two groups: Usual Care or Patient Navigation.
Participate will last up to 14 months and participants randomized to Patient Navigation may have about 14 sessions/calls with a Patient Navigator (30-45 minutes each) and complete 3 surveys (30-60 minutes each). All visits can be by phone or video.
What is being tested
- Patient Navigation (behavioral)
Sponsor: University of Utah · Participants: 429 · Started: Jul 10, 2026
Contact the study team
- Grace Sr. Clinical Research Coordinator · Phone: 385-315-0698
- Kristi Clinical Research Manager · Phone: 801-213-0799
Official record on ClinicalTrials.gov — NCT07586917
Locations in the U.S.
| Utah | University of Utah, Salt Lake City |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.