Clinical Trial

Optimizing Pregnancy and Treatment Interventions for Moms 3.0

Study acronym: OPTI-Mom
Recruiting
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Summary
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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-07-17
critical Primary endpoint(s) modified 2026-05-16
Trial Details
NCT Number NCT07586917
Lead Sponsor University of Utah
Conditions Opioid Abuse (Disorder), Stimulant Use Disorders
Enrollment 429 participants
Start Date 2026-07-10
Primary Completion 2029-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-16