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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery and three-month post-partum
Awards & highlights
SMART Trial 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.Check my eligibility
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.See study design
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.
SMART Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Activation Measure (PAM)
Treatment Engagement
Treatment Retention
SMART 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
Find a Location
Who is running the clinical trial?
Patient-Centered Outcomes Research InstituteOTHER
552 Previous Clinical Trials
29,997,594 Total Patients Enrolled
Yale UniversityLead Sponsor
1,854 Previous Clinical Trials
2,740,297 Total Patients Enrolled
Ariadna Forray, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with opioid addiction based on a questionnaire called the DSM-5 Opioid Use Disorder questionnaire.I am unable to understand or make decisions due to cognitive or emotional issues.I am a woman aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Collaborative Care (CC)
- Group 2: Extension for Community Healthcare Outcomes (ECHO)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widespread is this experiment's implementation?
"As of now, enrolment for this trial is available from 13 different clinics. These sites are dispersed in New London, New Britain, Waterbury and other cities; it's best to select the closest clinic to reduce travel demands when joining the study."
Answered by AI
Are there any available slots within the trial for individuals to participate?
"Affirmative. The details hosted on clinicaltrials.gov reveal that this medical experiment, which was first shared on June 18th 2020, is still searching for participants to enroll in the study. A total of 480 people will be accepted across 13 sites."
Answered by AI
What is the upper limit of individuals taking part in this experiment?
"Affirmative. Records from clinicaltrials.gov indicate that this research study, initially published on June 18th 2020, is now open for recruitment. 480 subjects must be enlisted across 13 distinct sites."
Answered by AI
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