Optimizing Pregnancy and Treatment Interventions for Moms 3.0

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07586917
Status
Not Yet Recruiting

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Conditions

  • Opioid Abuse (Disorder)
  • Stimulant Use Disorders

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient Navigation — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
429 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual Care
    This arm includes brief case management and referral.
  • Experimental: Patient Navigation
    The intervention portion consists of sessions delivered in both the participant's prenatal and postnatal period.

Primary Outcome Measure

Change in illicit opioid use [ Time Frame: 36 months ]

Central Contacts

  • Grace Sr. Clinical Research Coordinator
    385-315-0698
    [email protected]
  • Kristi Clinical Research Manager
    801-213-0799

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84108
Clinical Research Coordinator
[email protected]
801-213-0799
Gerald Cochran, PhD (PRINCIPAL_INVESTIGATOR)
Marcela Smid, MD (SUB_INVESTIGATOR)

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By research site
University of Utah· Salt Lake City, UT

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