Recruiting

Patient Navigation

Sponsor:

University of Utah

Code:

NCT07586917

Conditions

Opioid Abuse (Disorder)

Stimulant Use Disorders

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient Navigation

Study Details

Brief 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.

Conditions

Opioid Abuse (Disorder)

Stimulant Use Disorders

Study ID

NCT07586917

Start date

Jul 10, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

429 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Grace Sr. Clinical Research Coordinator

385-315-0698optimom@utah.edu

Kristi Clinical Research Manager

801-213-0799

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Clinical Research Coordinator

801-213-0799optimom@utah.edu

Principal Investigator:

Gerald Cochran, PhD

More Information

Sponsor

University of Utah

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-07-16.