Neuroplasticity in Maternal Opioid Use Disorder (OUD)
Key facts
- Who runs it
- Yale University
- Where
- New Haven, United StatesSee the site
- Trial code
- Status
- Suspended
- People taking part
- 15 people, planned
- Started
- 1 Jan 2023
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- ERPs with electroencephalography (EEG)
- MIO
- Record updated
- 14 September 2026
- Why it stopped
- PI in transition, assessing feasibility of study continuation
Who can take part
- Age
- 21 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Biological mother of infants between 4-months and 12-months of age
- 21-45 years of age at time of recruitment
- Enrolled in substance use treatment and on mediation for opioid use disorder (MOUD)
Who cannot take part
- Incapable of giving informed consent
- Child spends less than 50% of time in mother's custody
- Non-English-speaking
- Unable to complete the study because of pending legal cases or unable to supply two forms of contact for the purpose of follow-up
- Physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea)
Where in United States
- Yale Child Studies CenterNew Haven, United States
About the trial
What the trial wants to find out
Opioid use disorder (OUD) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. The perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. OUD is also associated with neural reorganization, specifically neural circuitry implicated in stress regulation and reward processes. Interventions should therefore take advantage of this changing perinatal biology to enhance treatment response by targeting the aberrant neural circuitry compromised by maternal OUD. The investigators have developed and refined an evidence-based intervention for mothers with OUD designed to target these neural mechanisms and enhance the reward of caregiving; however, this has yet to be formally tested. Therefore, the investigators will examine maternal neuroplasticity using high-dense array electroencephalography (EEG) in mothers with OUD in response to our intervention. There will be 1 laboratory visit at pre-treatment, followed by 12 sessions of the evidence-based parenting intervention, and 1 laboratory visit at post-treatment. This study will attempt to validate the importance of taking advantage of the neuroplasticity in the perinatal period to optimize outcomes for mothers with OUD.
The 2 groups in the trial
- Primary Objective: Event-Related Potentials (ERPs)Treatment being tested
Use ERPs elicited by unknown infant face and cry stimuli to determine whether neural markers translate to maternal mentalization in mothers with opioid use disorder (OUD) at 4-12 months postpartum
Treatment: ERPs with electroencephalography (EEG)
- Secondary Objective: ERPs + Mothering from the Inside Out (MIO)Treatment being tested
Use Event-Related Potentials (ERPs) elicited by unknown infant face and cry stimuli to determine whether neural response changes with participation in an evidence-based parenting intervention designed specifically for mothers with OUD: Mothering from the Inside Out (MIO).
Treatment: ERPs with electroencephalography (EEG) and MIO
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 September 2026