Patient Navigation for Opioid Addiction

(OPTI-Mom Trial)

Overseen By Grace Sr. Clinical Research Coordinator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Opioid use disorder medications

Disqualifiers: Terminate pregnancy, Psychotic episode, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a Patient Navigator helps pregnant women on Medicaid with opioid use disorder adhere to their treatment and reduce drug use. Participants will receive either usual care or additional support through sessions with a Patient Navigator. The goal is to assess whether this extra help improves their connection to services and use of medications for opioid addiction. The trial seeks pregnant women diagnosed with opioid use disorder, who are newly starting medication treatment, and who speak English. As an unphased trial, it offers participants the opportunity to contribute to understanding how additional support can enhance treatment outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be new to or just starting medications for opioid use disorder.

What prior data suggests that Patient Navigation is safe for pregnant Medicaid members with opioid use disorder?

Research shows that patient navigation is generally safe for people with opioid use disorder. Previous studies have demonstrated its use in healthcare settings without major safety issues. For example, one study found that pregnant individuals with opioid use disorder who used patient navigation had better health outcomes. In another study, patients who received navigation services engaged more with outpatient treatments after leaving the hospital, indicating that the approach was well-received.

No reports of serious negative effects from these navigation services exist. This suggests that patient navigation is safe and could help individuals stay involved in their care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Navigation approach for opioid addiction because it offers a personalized support system throughout both prenatal and postnatal periods. Unlike traditional care, which often involves brief case management and referrals, this method integrates continuous, tailored guidance, potentially leading to better long-term outcomes for mothers battling addiction. This hands-on, navigational support helps address the unique challenges of opioid addiction during a critical time in a patient's life, aiming to improve adherence to treatment and overall recovery success.

What evidence suggests that Patient Navigation is effective for opioid addiction?

Studies have shown that a patient navigator can improve outcomes for pregnant individuals dealing with opioid addiction. In this trial, participants in the Patient Navigation arm will receive support from a patient navigator, which previous studies have shown helps individuals attend treatment appointments more regularly and reduce opioid use more effectively than those without one. Another study found that patients reported fewer cravings and less use of other illegal drugs with support from a patient navigator. These findings suggest that guidance through healthcare greatly aids in adhering to treatment. Patient navigation connects people with necessary services and encourages the use of medications that support recovery. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant adults (18 or older) on Medicaid who have opioid use disorder, are at least 7 weeks pregnant, and are new to medication treatment for opioid use. Participants must speak English and agree to share their medical records.

Inclusion Criteria

I am 18 years old or older.

I have an opioid use disorder.

I am at least 7 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

The PN model is refined to incorporate CM strategies targeting stimulant use, involving multidisciplinary experts and individuals with lived experience.

Not specified

Implementation Strategy Development

Qualitative interviews and focus groups are conducted to identify barriers and facilitators to implementing PN within Medicaid systems.

Not specified

Randomized Controlled Trial

Participants are randomized to Patient Navigation or Usual Care. The PN intervention includes up to 10 prenatal sessions and 4 postpartum sessions.

14 months

14 sessions/calls with a Patient Navigator

Follow-up

Participants are monitored for changes in illicit opioid use and other secondary outcomes.

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview

The study compares usual care with a program called Patient Navigation, where participants get regular phone or video sessions with a navigator to help them stay in treatment and connect with services. Participation lasts up to 14 months.

How Is the Trial Designed?

Group I: Patient Navigation Experimental Treatment 1 Intervention

The intervention portion consists of sessions delivered in both the participant's prenatal and postnatal period.

Group II: Usual Care Active Control 1 Intervention

This arm includes brief case management and referral.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1.

recoveryanswers.org

recoveryanswers.org/research-post/traveling-companions-results-patient-navigation-intervention-for-pregnant-people-opioid-use-disorder/

Results of a patient navigation intervention for pregnant ...

That said, participants in the patient navigation condition had greater improvements in opioid use disorder care attendance and opioid use outcomes than those ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7861202/

Outcomes for patients receiving telemedicine-delivered ... - PMC

Effective evidence-based treatments for Opioid Use Disorder (OUD) exist. Methadone, buprenorphine, and naltrexone are all FDA approved for the treatment of OUD.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0196064422011647

Effectiveness of Substance Use Navigation for Emergency ...

Results. There were 2,418 adult patients who presented from September 2021 to January 2022 with a substance use disorder diagnosis related to alcohol, opioid, ...

4.

withpower.com

withpower.com/trial/phase-opioid-related-disorders-8-2023-0db2d

Incentivized Adherence + Patient Navigation for Opioid ...

This trial tests a new approach, called MHealth Incentivized Adherence Plus Patient Navigation, to assist individuals with opioid use disorder (OUD) who ...

5.

cdc.gov

cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates

In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

6.

healthaffairs.org

healthaffairs.org/doi/10.1377/hlthaff.2025.00333

Increasing Emergency Department Patient Navigation And ...

Buprenorphine and methadone are opioid agonist medications that reduce both all-cause and overdose-associated mortality among people with opioid ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S037687162400245X

Patient navigation for perinatal substance use disorder ...

Patient navigation was associated with reduced maternal substance use, increased receipt of services, and improved maternal and neonatal health.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9491361/

Navigation Services to Avoid Rehospitalization among ... - PMC

This study was a parallel two-group randomized controlled trial that examined NavSTAR compared to TAU. Participants were 400 hospitalized patients who met ...