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Support Models for Opioid Use Disorder in Pregnancy (SMART Trial)

N/A

Waitlist Available

Led By Ariadna Forray, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delivery and three-month post-partum

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different models of support for pregnant women with an opioid use disorder.

Who is the study for?

This trial is for pregnant women over 18 with opioid use disorder (OUD), who can communicate in English, are not planning to move from the treatment area, and can follow the study schedule. They must be less than 34 weeks pregnant and not currently hospitalized or facing incarceration.

What is being tested?

The study is comparing two support models for treating OUD in pregnancy: Collaborative Care (CC) and Extension for Community Healthcare Outcomes (ECHO). It aims to determine which method provides better outcomes during the perinatal period.

What are the potential side effects?

Since this trial involves care models rather than medications, there may not be direct side effects like those seen with drugs. However, participants might experience stress or discomfort related to regular check-ins and adherence to treatment protocols.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand or make decisions due to cognitive or emotional issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delivery and three-month post-partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delivery and three-month post-partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery and three-month post-partum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Activation Measure (PAM)

Treatment Engagement

Treatment Retention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Collaborative Care (CC)Experimental Treatment1 Intervention

The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation the care manager will ask participants to complete an assessment battery of self-reported measures.

Group II: Extension for Community Healthcare Outcomes (ECHO)Active Control1 Intervention

ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Collaborative Care (CC)

2014

N/A

~200

0 / 1Eligibility criteria met