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NCT07632053NARecruiting

Postpartum Intervention for Mothers With Opioid Use Disorders (R33)

Stony Brook University

Start Date

7/1/2025

Completion Date

7/1/2028

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.

Detailed Description

Informed by the results from the R61 phase, we have fine-tuned the exact hypotheses as follows: Post-intervention, mothers with OUD randomized to receive MP, compared to control group of enhanced usual care (EUC), will exhibit Hypothesis (a) - lower Evoked Response Potential (ERP) responses to infant's crying and Hypothesis (b) - normalized fMRI-assessed brain activity in key MBN regions, e.g., hypothalamus, amygdala and periaqueductal gray. Hypothesis (c) The pre-to-post improvements in mothers' drug craving, mood and parental stress will be greater for mothers in the vMP vs. EUC conditions. Hypothesis (d) Assuming Ha-c are confirmed, we will test whether the clinical benefits of vMP are mediated through vMP-induced changes in the MBN.

Eligibility Criteria

Age Range: 18 years to 50 years

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

Interventions

BEHAVIORAL

Mom Power

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Conditions

Opioid Use DisorderParent-Child Relations

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States

Stony Brook University

Stony Brook, New York 11794

United States