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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stimulant Use Disorders; Opioid Abuse (Disorder)
• Intervention / Treatment: Behavioral: Patient Navigation

Detailed Description

Pregnant and postpartum individuals with opioid use disorder (OUD) experience a disproportionate burden of morbidity, mortality, and overdose risk in the United States. Increasingly, this population is affected by co-occurring stimulant use disorder (StUD), which further complicates treatment engagement and outcomes. Although many individuals attempt to discontinue substance use during pregnancy, withdrawal symptoms, psychosocial stressors, stigma, and unmet health-related social needs frequently contribute to return to use. Return to use is strongly associated with treatment disengagement, adverse maternal and neonatal outcomes, and increased risk of overdose.

Medication for opioid use disorder (MOUD), including buprenorphine and methadone, is the standard of care during pregnancy and is associated with reduced overdose risk and improved outcomes. However, MOUD alone is often insufficient to address complex behavioral, social, and structural barriers to sustained recovery. In addition, there are no FDA-approved medications for stimulant use disorder, and optimal behavioral strategies to address co-occurring OUD and StUD and improve treatment retention remain unclear.

Existing integrated and comprehensive care models have shown benefits but are often resource-intensive, difficult to scale, and may inadequately address social determinants of health and patient self-management. Patient Navigation (PN) is a patient-centered, scalable model designed to reduce barriers to care, improve coordination across fragmented health and social service systems, and provide individualized motivational support. PN has demonstrated effectiveness across chronic health conditions and shows promise for improving outcomes among pregnant persons with OUD.

This study evaluates an enhanced PN intervention for pregnant persons with OUD with or without co-occurring StUD (OUD±StUD). The intervention integrates strengths-based case management, motivational interviewing, and contingency management (CM), an evidence-based behavioral approach that reinforces treatment engagement and behavior change through incentives and is among the most effective interventions for stimulant use.

This mixed-methods, type 2 hybrid effectiveness-implementation study includes three components:

Intervention Development (Specific Aim 1):

The PN model will be refined to incorporate CM strategies targeting stimulant use. Development will follow an evidence-informed adaptation framework and involve multidisciplinary experts and individuals with lived experience. The result will be an enhanced PN intervention manual and navigator training approach designed to address both OUD and StUD within the perinatal context.

Implementation Strategy Development (Specific Aim 2):

Qualitative interviews and focus groups will be conducted with Medicaid program leaders, healthcare professionals, and individuals with lived experience to identify barriers and facilitators to implementing PN within Medicaid systems. Using implementation science frameworks, findings will be translated into a structured implementation playbook outlining strategies for adoption, integration, and sustainability of PN services in real-world settings.

Randomized Controlled Trial (Specific Aim 3):

The effectiveness of PN will be evaluated in a randomized controlled trial comparing PN to usual care (UC), defined as standard case management and referral services. Eligible participants will include pregnant individuals (≥18 years) with diagnosed OUD, newly initiated on MOUD, and enrolled in participating Medicaid managed care plans.

Participants will be randomized 1:1 to PN or UC. The PN intervention will include up to 10 prenatal sessions and 4 postpartum sessions delivered by trained navigators via phone, telehealth, or in-person. Sessions will focus on facilitating linkage to and retention in substance use treatment, MOUD adherence, engagement in medical and behavioral health care, and connection to social services addressing health-related social needs. The intervention also incorporates contingency management to reinforce treatment participation and behavior change. Usual care participants will receive standard health plan care management services and referrals.

The primary outcome is change in illicit opioid use, measured using urine toxicology screening and the Timeline Follow-Back method. Secondary outcomes include stimulant use, MOUD adherence, participation in substance use treatment, non-fatal overdose, and resolution of health-related social needs. Additional outcomes include healthcare utilization and costs for both participants and their infants, derived from administrative claims and medical records.

Implementation outcomes will be assessed using the RE-AIM framework, including reach (enrollment and participation), effectiveness (clinical outcomes), adoption (organizational readiness), implementation (intervention fidelity), and maintenance (sustained healthcare utilization and outcomes).

This study is conducted within Medicaid managed care settings, which provide a highly relevant and scalable context given that Medicaid covers a substantial proportion of U.S. births and individuals with OUD. By integrating intervention development, implementation planning, and a rigorously designed randomized trial, this study aims to generate actionable evidence regarding both clinical effectiveness and real-world feasibility.

Findings from this study are expected to inform broader dissemination of patient navigation within Medicaid and other healthcare systems, with the goal of improving treatment engagement, reducing substance use and overdose risk, and improving maternal and neonatal outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 429
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Sr. Clinical Research Coordinator; Phone Number: 385-315-0698; Email: optimom@utah.edu
• Study Contact Backup: Name: Kristi Clinical Research Manager; Phone Number: 801-213-0799

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah
      • Contact: Clinical Research Coordinator; Phone Number: 801-213-0799; Email: optimom@utah.edu
      • Principal Investigator: Gerald Cochran, PhD
      • Sub-Investigator: Marcela Smid, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Patient 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in illicit opioid use	14-panel urine toxicology Timeline Follow Back (TLFB)	36 months

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Health Services Administration; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Patient Navigation
• Other Study ID Numbers: 195295; U01CE003831 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No