RecruitingNot Applicable

Postpartum Intervention for Mothers With Opioid Use Disorders (R33)

United States80 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical trial enrollment counts.

Timeframe: 3 years

Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.

Timeframe: 3 years

Electroencephalography (EEG) Brain Imaging scans counts.

Timeframe: 3 years

Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.

Timeframe: 3 years

Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).

Timeframe: 3 years

Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).

Timeframe: 3 years

Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).

Timeframe: 3 years

Trial details

NCT IDNCT07632053

SponsorStony Brook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

James E Swain, MD, PhD

516-838-7604 james.swain@stonybrookmedicine.edu

View on ClinicalTrials.gov More Opioid Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinical trial enrollment counts.

Timeframe: 3 years

Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.

Timeframe: 3 years

Electroencephalography (EEG) Brain Imaging scans counts.

Timeframe: 3 years

Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.

Timeframe: 3 years

Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).

Timeframe: 3 years

Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).

Timeframe: 3 years

Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).

Timeframe: 3 years