Treatment of Pregnant Women With OUD (SMART)

  • End date
    Jul 14, 2023
  • participants needed
  • sponsor
    Yale University
Updated on 14 May 2022


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


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.

Condition Opioid-use Disorder
Treatment Collaborative Care (CC), Extension for Community Healthcare Outcomes (ECHO)
Clinical Study IdentifierNCT04240392
SponsorYale University
Last Modified on14 May 2022


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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 December 15, 2022
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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