CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 230 enrolled
Drug / intervention
Collaborative Care (CC) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04240392
NCT04240392N/ACompleted

Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women

Yale University·interventional·Posted Jan 27, 2020·Updated May 21, 2025

In Brief

A clinical study evaluating Collaborative Care (CC) and Extension for Community Healthcare Outcomes (ECHO) for Opioid-use Disorder. Completed, enrolled 230 participants across 11 sites.

Detailed Summary

The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 27, 2020
Enrollment StartJun 18, 2020
Primary CompletionOct 10, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.4 years ago

Interventions

Collaborative Care (CC)behavioral

The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner.

Extension for Community Healthcare Outcomes (ECHO)behavioral

The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.