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Treatment of Pregnant Women With OUD | Clinical Trials | Clareo Health

COMPLETEDNA

Treatment of Pregnant Women With OUD

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

NCT04240392•Yale University

View on ClinicalTrials.gov

Summary

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

Detailed Description

The investigators are proposing a cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with an OUD: 1) a collaborative care (CC) approach based upon the Massachusetts Office-Based-Opioid Treatment (OBOT) Model that would provide onsite training, and support to providers and participants through the use of care managers (CMs) vs 2) a telesupport approach modeled on the Project Extension for Community Healthcare Outcomes (ECHO), a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated informed consent form
•Females age 18 or older
•Documented pregnancy in the medical record at less than 34 weeks gestation
•Delivery date no later than July 1, 2024
•Willingness to adhere to the study schedule
•Confirmed opioid use disorder by the DSM-5 Opioid Use Disorder questionnaire
•Ability to communicate in English
•No current plan to move out of the obstetrical provider treatment area within the study timeframe of approximately 44 weeks

Exclusion Criteria

•Experiencing cognitive or emotional impairment that precludes the participant from providing informed consent
•Current hospitalization, incarceration, or institutionalization (if women present for care after institutionalization, participation is possible
•Current court case pending that would make incarceration likely during the study treatment period (approximately 44 weeks)

Locations (11)

Hartford Hospital

Hartford, Connecticut, United States

Hospital of Central CT

New Britain, Connecticut, United States

Yale New Haven Hospital Maternal Fetal Medicine Unit

New Haven, Connecticut, United States

Yale New Haven Hospital Women's Center/Hill Health Center

New Haven, Connecticut, United States

Coastal ObGyn & Midwifery

New London, Connecticut, United States

OB Gyn Services PC

Norwich, Connecticut, United States

Essex County ObGyn

Beverly, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

AFA Obstetrics & Gynecology

Concord, Massachusetts, United States

Women's Health, Lowell General Hospital

Lowell, Massachusetts, United States

Key Dates

Start Date

June 18, 2020

Primary Completion Date

October 10, 2024

Completion Date

October 10, 2024

Last Updated

May 21, 2025

Enrollment

230

ACTUAL participants

Conditions

Opioid-use Disorder

Interventions

Collaborative Care (CC)

BEHAVIORAL

Extension for Community Healthcare Outcomes (ECHO)

BEHAVIORAL

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

NCT04197921

Opioid-use DisorderSubstance Use Disorders

View study

RECRUITINGNA

Optimization of NIBS for Treatment of Addiction

NCT04379115

Opioid-use DisorderChronic Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Pregnant Women With OUD

Inclusion Criteria

Exclusion Criteria

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

Optimization of NIBS for Treatment of Addiction

Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

The Youth Opioid Recovery Support (YORS) Intervention

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