Opioid-use DisorderSMARTNCT04240392

Treatment of Pregnant Women With OUD

A study testing Collaborative Care (CC) and Extension for Community Healthcare Outcomes (ECHO) in people with Opioid-use Disorder, run by Yale University at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators are testing two models of support for pregnant women with an opioid use disorder (OUD) Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Opioid-use Disorder
What is being tested?: Collaborative Care (CC) and Extension for Community Healthcare Outcomes (ECHO)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 11 sitesUnited States
Study dates: 18 Jun 2020to 10 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Essex County ObGyn
Beverly, Massachusetts, 01915
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
AFA Obstetrics & Gynecology
Concord, Massachusetts, 01742
Hartford Hospital
Hartford, Connecticut, 06106
Women's Health, Lowell General Hospital
Lowell, Massachusetts, 01854
Hospital of Central CT
New Britain, Connecticut, 06052
Yale New Haven Hospital Maternal Fetal Medicine Unit
New Haven, Connecticut, 06511
Yale New Haven Hospital Women's Center/Hill Health Center
New Haven, Connecticut, 06511
Coastal ObGyn & Midwifery
New London, Connecticut, 06320
OB Gyn Services PC
Norwich, Connecticut, 06360
Wesson's Women's Clinic UMASS Baystate
Springfield, Massachusetts, 01199

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Opioid-use Disorder
Being tested: Collaborative Care (CC), Extension for Community Healthcare Outcomes (ECHO)
Keywords: opioid, pregnant
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Collaborative Care (CC)Behavioural
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)Behavioural
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.

Study groups in NCT04240392
Study group	Role	What they receive
Collaborative Care (CC)	Experimental	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. Receives: Behavioral: Collaborative Care (CC)
Extension for Community Healthcare Outcomes (ECHO)	Active comparator	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. Receives: Behavioral: Extension for Community Healthcare Outcomes (ECHO)

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Engagement
Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD
Measured: 30 days from baseline
Treatment Retention
Dichotomous- A participant is considered to have been successfully retained in the study if the participant remained in treatment with no stoppage of greater than 1 month.
The numbers reported below for 3 months postpartum differ from those in the Participant Flow, as the numbers in the Participant Flow represent only completed REDCap survey assessments. For the retention outcome, we could utilize additional sources of data collection, such as medical records, site reports, and treatment utilization forms (which were done more frequently than survey assessments), thus resulting in a higher N for this outcome.
Measured: delivery and three-month post-partum
Patient Activation Measure (PAM)
The PAM is a patient-centered questionnaire that measures health care knowledge, beliefs, skills and confidence in managing illnesses. The PAM has 13 items with a 5-point Likert response scale. The raw scores are summed and transformed to 0-100 metric (0 = lowest activation level, 100 = highest).
The Week 26 numbers below are lower than those in the Participant Flow because participants were allowed to enter the study after 26 weeks of pregnancy and did not have a separate baseline and Week 26 PAM assessment; instead, it was counted as their baseline PAM assessment only. However, other study assessments were unique to week 26 and were completed concurrently with baseline assessments, which were counted separately, accounting for the higher N for Week 26 in the Participant Flow.
The postpartum ECHO sample size is 85 rather than 86 because one participant skipped the PAM questions during their 3-month postpartum assessment.
Measured: baseline, week 26, week 36 and 3-monhts post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 202010 Oct 2024

First posted27 Jan 2020
Study start18 Jun 2020
Primary completion10 Oct 2024
Study completion10 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study will use a matched-pair cluster randomized trail design. The investigators will match clinical centers in pairs. The participants in each pair will be randomly assigned to either CC or ECHO using computer generated random numbers.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04240392
Sponsor's protocol ID: 2000027031
Other IDs: MAT-2018C2-12891
Acronym: SMART
Status last verified: May 2025
First submitted: 5 Sep 2019
Last updated: 21 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-Identified data will be made available to other researchers upon request. Please contact Dr. Yonkers.

Publications

Kaufman JS, Yonkers KA, Maltz C, Friedhoff CM, Londono Tobon A, Mele A, Tessier-Kay M, Grechukhina O, Lipkind H, Byatt N, Forray A. Reporting Perinatal Substance Use to Child Protective Services: Obstetric Provider Perspectives on the Impact on Care. J Womens Health (Larchmt). 2024 Nov;33(11):1501-1508. doi: 10.1089/jwh.2023.0822. Epub 2024 May 21.
PubMed 38770764
Forray A, Mele A, Byatt N, Londono Tobon A, Gilstad-Hayden K, Hunkle K, Hong S, Lipkind H, Fiellin DA, Callaghan K, Yonkers KA. Support Models for Addiction Related Treatment (SMART) for pregnant women: Study protocol of a cluster randomized trial of two treatment models for opioid use disorder in prenatal clinics. PLoS One. 2022 Jan 13;17(1):e0261751. doi: 10.1371/journal.pone.0261751. eCollection 2022.
PubMed 35025898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Support Models for Addiction Related Treatment (SMART) Trial of Opioid Use Disorder OUD) in Pregnant Women
ClinicalTrials.gov ID: NCT04240392
Acronym / sponsor ID: SMART / 2000027031
Conditions: Opioid-use Disorder
Keywords: opioid, pregnant
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 18 Jun 2020 (actual)
Primary completion: 10 Oct 2024 (actual)
Study completion: 10 Oct 2024 (actual)
First posted: 27 Jan 2020 (actual)
Results: Posted 21 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This study will use a matched-pair cluster randomized trail design. The investigators will match clinical centers in pairs. The participants in each pair will be randomly assigned to either CC or ECHO using computer generated random numbers.

Arm	Type	Receives
Collaborative Care (CC)	Experimental	Behavioral: Collaborative Care (CC)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.
Extension for Community Healthcare Outcomes (ECHO)	Active comparator	Behavioral: Extension for Community Healthcare Outcomes (ECHO)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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Collaborative Care (CC)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.	Behavioural	Collaborative Care (CC)
Extension for Community Healthcare Outcomes (ECHO)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.	Behavioural	Extension for Community Healthcare Outcomes (ECHO)

Primary outcome

Treatment Engagement
Time frame: 30 days from baseline
Dichotomous - A participant completes engagement if the baseline assessment is completed and the participant has had greater than 2 visits for treatment of OUD
Treatment Retention
Time frame: delivery and three-month post-partum
Dichotomous- A participant is considered to have been successfully retained in the study if the participant remained in treatment with no stoppage of greater than 1 month. The numbers reported below for 3 months postpartum differ from those in the Participant Flow, as the numbers in the Participant Flow represent only completed REDCap survey assessments. For the retention outcome, we could utilize additional sources of data collection, such as medical records, site reports, and treatment utilization forms (which were done more frequently than survey assessments), thus resulting in a higher N for this outcome.
Patient Activation Measure (PAM)
Time frame: baseline, week 26, week 36 and 3-monhts post-partum
The PAM is a patient-centered questionnaire that measures health care knowledge, beliefs, skills and confidence in managing illnesses. The PAM has 13 items with a 5-point Likert response scale. The raw scores are summed and transformed to 0-100 metric (0 = lowest activation level, 100 = highest). The Week 26 numbers below are lower than those in the Participant Flow because participants were allowed to enter the study after 26 weeks of pregnancy and did not have a separate baseline and Week 26 PAM assessment; instead, it was counted as their baseline PAM assessment only. However, other study assessments were unique to week 26 and were completed concurrently with baseline assessments, which were counted separately, accounting for the higher N for Week 26 in the Participant Flow. The postpartum ECHO sample size is 85 rather than 86 because one participant skipped the PAM questions during their 3-month postpartum assessment.

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Collaborative Care (CC)	126	102
Extension for Community Healthcare Outcomes (ECHO)	102	86

Primary outcome: Treatment Engagement

Time frame: 30 days from baseline. Count of participants. Unit: Participants

Measure	Collaborative Care (CC) n = 187	Extension for Community Healthcare Outcomes (ECHO) n = 156
Not engaged	78	64
Engaged	109	92

Collaborative Care (CC) vs Extension for Community Healthcare Outcomes (ECHO): Odds Ratio (OR): 1.369 (95% CI 0.462 to 4.055), p = 0.5340, Mixed Models Analysis

Population analysed: The engagement cohort included individuals who did not enroll in the study.

Primary outcome: Treatment Retention

Time frame: delivery and three-month post-partum. Count of participants. Unit: Participants

Measure	Collaborative Care (CC) n = 126	Extension for Community Healthcare Outcomes (ECHO) n = 102
Delivery: Not retained	17	12
Delivery: Retained	99	87
3 months post partum: Not retained	18	11
3 months post partum: Retained	96	84

Collaborative Care (CC) vs Extension for Community Healthcare Outcomes (ECHO): Odds Ratio (OR): 0.803 (95% CI 0.326 to 1.979), p = 0.600, Mixed Models Analysis
Collaborative Care (CC) vs Extension for Community Healthcare Outcomes (ECHO): Odds Ratio (OR): 0.709 (95% CI 0.254 to 1.975), p = 0.471, Mixed Models Analysis

Population analysed: Data presented here is from all participants who completed assessments at each time frame.

Primary outcome: Patient Activation Measure (PAM)

Time frame: baseline, week 26, week 36 and 3-monhts post-partum. Mean (Standard Deviation). Unit: score on a scale

Measure	Collaborative Care (CC) n = 117	Extension for Community Healthcare Outcomes (ECHO) n = 94
Baseline	74.77 (19.03)	76.6 (17.75)
Week 26	78.32 (17.77)	78.14 (18.11)
Week 36	77.37 (16.35)	78.55 (17.47)
3 months post partum	76.62 (17.26)	78.25 (16.52)

Collaborative Care (CC) vs Extension for Community Healthcare Outcomes (ECHO): Beta-coefficient: 1.53 (95% CI -3.13 to 6.19), p = 0.518, Mixed Models Analysis
Collaborative Care (CC) vs Extension for Community Healthcare Outcomes (ECHO): Beta-coefficient: 0.32 (95% CI -4.41 to 5.06), p = 0.893, Mixed Models Analysis

Population analysed: Data presented here is from all participants who completed assessments at each time frame. The numbers 117 and 94 represent the total number of participants with a PAM score recorded at any time point, as they were included in the analysis model. There were 17 participants who did not complete the PAM assessment at any time point.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Collaborative Care (CC)	22 of 126 (17.5%)	0 of 126 (0%)	0 of 126
Extension for Community Healthcare Outcomes (ECHO)	18 of 102 (17.6%)	0 of 102 (0%)	0 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38770764Kaufman JS, Yonkers KA, Maltz C, Friedhoff CM, Londono Tobon A, Mele A, Tessier-Kay M, Grechukhina O, Lipkind H, Byatt N, Forray A. Reporting Perinatal Substance Use to Child Protective Services: Obstetric Provider Perspectives on the Impact on Care. J Womens Health (Larchmt). 2024 Nov;33(11):1501-1508. doi: 10.1089/jwh.2023.0822. Epub 2024 May 21.
Derived from this study: PubMed 35025898Forray A, Mele A, Byatt N, Londono Tobon A, Gilstad-Hayden K, Hunkle K, Hong S, Lipkind H, Fiellin DA, Callaghan K, Yonkers KA. Support Models for Addiction Related Treatment (SMART) for pregnant women: Study protocol of a cluster randomized trial of two treatment models for opioid use disorder in prenatal clinics. PLoS One. 2022 Jan 13;17(1):e0261751. doi: 10.1371/journal.pone.0261751. eCollection 2022.
Individual participant dataSharing planned: Yes. De-Identified data will be made available to other researchers upon request. Please contact Dr. Yonkers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ariadna Forray, MD principal investigator

Yale University

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Collaborative Care (CC) and Extension for Community Healthcare Outcomes (ECHO) in people with Opioid-use Disorder, run by Yale University at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Engagement (time frame: 30 days from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04240392, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.