RecruitingNot ApplicableNCT07586917

Optimizing Pregnancy and Treatment Interventions for Moms 3.0

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


Sponsor

University of Utah

Enrollment

429 participants

Start Date

Jul 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Patient Navigation for people with opioid abuse (disorder) and stimulant use disorders. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPatient Navigation

The prenatal portion will consist of 7-10 sessions, with the number of sessions received being dependent on the pregnancy week enrolled and the date of delivery. Each session will last 45-60 minutes and will be delivered by a study navigator. Participants who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce recovery, Medication for Opioid Use adherence, and treatment retention. The postnatal portion of the intervention will be delivered in 4 sessions over 8 weeks.


Locations(1)

University of Utah

Salt Lake City, Utah, United States

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NCT07586917


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