NCT07632053 Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
| NCT ID | NCT07632053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stony Brook University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-07-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=\~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.
Eligibility Criteria
Inclusion Criteria: * mothers with diagnosis of Opioid Use Disorder (OUD); and/or receiving medication assisted treatment (such as buprenorphine or methadone) * with a child aged 5 or less * able to read, hear and understand English adequately enough to provide informed consent Exclusion Criteria: * require immediate clinical care for suicidal/homicidal risk or psychosis; * For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they: (1) have ferromagnetic metal in their heads (2) have severe claustrophobia that prevents participation in the neuroimaging (3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma
Contact & Investigator
James E Swain, MD, PhD
PRINCIPAL INVESTIGATOR
Stony Brook University
Frequently Asked Questions
Who can join the NCT07632053 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07632053 currently recruiting?
Yes, NCT07632053 is actively recruiting participants. Contact the research team at james.swain@stonybrookmedicine.edu for enrollment information.
Where is the NCT07632053 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Stony Brook, United States.
Who is sponsoring the NCT07632053 clinical trial?
NCT07632053 is sponsored by Stony Brook University. The principal investigator is James E Swain, MD, PhD at Stony Brook University. The trial plans to enroll 80 participants.