Neuroplasticity in Maternal Opioid Use Disorder (OUD)

NCT ID: NCT05495984

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

This is a study conducted at the Child Study Center (CSC) in the Yale School of Medicine. It involves mothers in treatment for OUD who are caring for infants who are 4-12 months old.

15 mothers will complete 1 study visit, which will last 2.5 hours. It will start with informed consent and then will include demographics, EEG/ERP, a multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).

Participants will then complete 12 treatment (Mothering from the Inside Out (MIO)) visits, and 1 post-treatment data collection visit.

Visits 2-13 (1 hour each) consist of participation in Mothering from the Inside Out (MIO).

Visit 14 (2.5 hours) includes participation in the ERP paradigm and the multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary Objective: Event-Related Potentials (ERPs)

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

Group Type: EXPERIMENTAL

ERPs with electroencephalography (EEG)

Intervention Type: BEHAVIORAL

E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes (ERPs). Visual stimuli will include photographs of color photographs of unfamiliar infants (aged 5- 10 months) balanced for ethnicity (Black/White) and gender (male/female) displaying happy neutral, and sad affective expressions. Auditory stimuli will include 2-second audio clips of high-distress and low-distress infant cries. Experimental procedure: Trials will consist of a central fixation cross (jittered 400-600ms), stimulus presentation (500ms faces, 2000ms cries), and blank screen (1000ms). Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. A 128 Ag/Silver Chloride (AgCl) electrode net will be soaked in a warm potassium chloride solution, and net electrodes will be spaced evenly and symmetrically on each participant's head to cover the scalp.

Secondary Objective: ERPs + Mothering from the Inside Out (MIO)

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).

Group Type: EXPERIMENTAL

ERPs with electroencephalography (EEG)

Intervention Type: BEHAVIORAL

E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes (ERPs). Visual stimuli will include photographs of color photographs of unfamiliar infants (aged 5- 10 months) balanced for ethnicity (Black/White) and gender (male/female) displaying happy neutral, and sad affective expressions. Auditory stimuli will include 2-second audio clips of high-distress and low-distress infant cries. Experimental procedure: Trials will consist of a central fixation cross (jittered 400-600ms), stimulus presentation (500ms faces, 2000ms cries), and blank screen (1000ms). Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. A 128 Ag/Silver Chloride (AgCl) electrode net will be soaked in a warm potassium chloride solution, and net electrodes will be spaced evenly and symmetrically on each participant's head to cover the scalp.

MIO

Intervention Type: BEHAVIORAL

A 12-week, manualized, individual parenting psychotherapy developed specifically for mothers with addictions administered by the Principal Investigator. It is designed to foster a mother's capacity for mentalization or reflective functioning (RF). MIO is offered in conjunction with standard addiction treatment.

Interventions

ERPs with electroencephalography (EEG)

E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes (ERPs). Visual stimuli will include photographs of color photographs of unfamiliar infants (aged 5- 10 months) balanced for ethnicity (Black/White) and gender (male/female) displaying happy neutral, and sad affective expressions. Auditory stimuli will include 2-second audio clips of high-distress and low-distress infant cries. Experimental procedure: Trials will consist of a central fixation cross (jittered 400-600ms), stimulus presentation (500ms faces, 2000ms cries), and blank screen (1000ms). Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. A 128 Ag/Silver Chloride (AgCl) electrode net will be soaked in a warm potassium chloride solution, and net electrodes will be spaced evenly and symmetrically on each participant's head to cover the scalp.

Intervention Type: BEHAVIORAL

MIO

A 12-week, manualized, individual parenting psychotherapy developed specifically for mothers with addictions administered by the Principal Investigator. It is designed to foster a mother's capacity for mentalization or reflective functioning (RF). MIO is offered in conjunction with standard addiction treatment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alkermes, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Lowell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Helena Rutherford, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Child Studies Center

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amanda Lowell, PhD

Role: CONTACT

amanda.lowell@yale.edu

321-277-2516

Helena Rutherford, PhD

Role: CONTACT

helena.rutherford@yale.edu

203-737-3408

Other Identifiers

2000033065

Identifier Type: -

Identifier Source: org_study_id