Optimizing Pregnancy and Treatment Interventions for Moms 3.0

ConditionsOpioid Abuse (Disorder)Stimulant Use Disorders

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorUniversity of Utah

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult (≥18 years)

Opioid use disorder

≥7 weeks gestation

Medication for opioid use disorder naive or newly initiated (≤6 weeks MOUD)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

429 Participants

are divided into 2 treatment groups

Group A: Usual CareNo intervention 0 interventions

Group B: Patient NavigationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in illicit opioid use

14-panel urine toxicology Timeline Follow Back (TLFB)

Time frame

36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Source ClinicalTrials.gov

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