Postpartum Intervention for Mothers With Opioid Use Disorders — PIMO  

Opioid Use Disorder Clinical Trial

Official title: Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms

Status Recruiting

Clinical Trial Summary

Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention "Mom Power" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample. The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.

Clinical Trial Description

Postpartum Intervention for Mothers with Opioid Use Disorders - Brain-Behavior Mechanisms Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many suffering comorbid mood disorders. Despite receiving "gold standard" buprenorphine treatment to reduce withdrawal, OUD mothers still suffer have cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. Parenting interventions have been established to improve parent mood and sensitive caregiving behaviors for high-risk non-OUD populations. "Mom Power" (MP) is an evidence-based 13-session psychosocial mother-child intervention established to enhance emotionally sensitive caregiving, while concurrently reducing parental stress and depression for non-OUD mothers. The investigators have demonstrated feasibility of with virtual MP (vMP) and for MP with substance use disorders. However, vMP for mothers with OUD has not been studied with respect to drug use reduction or mood improvement. The investigators have also established brain mechanisms that regulate parenting. Recent work from the investigators has established that a parenting intervention for non-OUD mothers was associated with a larger enhancement of evoke potential responses (ERPs) for emotional faces relative to neutral faces and that the magnitude of ERP responses to emotional faces was associated with observed maternal sensitivity. Using functional magnetic resonance imaging (fMRI) of the brain, the investigators have also established a Maternal Behavior Neurocircuit (MBN) that regulates flexible responses to the demands of their own infant - such as to the unique, ethologically salient own-baby cry and face stimuli during the early postpartum period. The investigators have established fMRI maternal brain changes associated with MP in non-OUD mothers, and brain effects of OUD on mothers. However, it is unknown how parental brain mechanisms through which parenting interventions may work for mothers with OUD, such as affecting ERP or fMRI responses to baby stimuli in the MBN. Central hypotheses: Mothers with OUD who get virtual MP (vMP), compared to matched controls, will show improved drug craving, mood, and stress symptoms, via changes in pre-specified MBN brain regions. In the high-risk R61 phase, the investigators will establish if vMP (n=25) for OUD can be implemented and improve mood, reduce drug use and affect ERP brain responses to baby pictures compared with control (n=25). If hypotheses in the R61 are confirmed, the investigators will confirm and expand this breakthrough with the R33 Phase (n=160, 80/group), adding richer maternal outcome measures and MBN fMRI. This research will elucidate the effects of parenting intervention MP on drug use and brain function for OUD mothers - with translational potential for biomarker and treatment development. ;

Related Conditions & MeSH terms

• Disease
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

• NCT number: NCT05614661
• Study type: Interventional
• Source: Stony Brook University
• Contact: Deanna Parisi, MPH
• Phone: 5167437710
• Email: deanna.parisi@stonybrookmedicine.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Completion date: June 30, 2024