Clinical trial NCT05495984: Neuroplasticity in Maternal Opioid Use Disorder (OUD)
Official title: Neuroplasticity in Maternal Opioid Use Disorder (OUD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
First posted: 2022-08-10
Enrollment: 15
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All participants (n=15) will complete Study Visit 1 for the Primary Objective, and Study Visits 2-14 for the Secondary Objective.
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli
timeFrame: Week 1 and Week 14
measure: Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)
timeFrame: Week 1 and Week 14
measure: Change in mothers' reflective functioning assessed using the self-report Parental Reflective Functioning Questionnaire (PRFQ)
timeFrame: Week 1 and Week 14
measure: Change in mothers' certainty about mental states assessed using the self-report Certainty about Mental States Questionnaire (CAMSQ)
timeFrame: Week 1 and Week 14
measure: Change in mothers' mind-mindedness assessed using the Five-Minute Speech Sample (MM)
timeFrame: Week 1 and Week 14
Secondary outcomes:
measure: Mothers' baseline substance use assessed using the Addiction Severity Index (ASI-Lite)
timeFrame: Week 1
measure: Change in mothers' depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Week 1 and Week 14
measure: Change in mothers' depression assessed using the Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Week 1 and Week 14
measure: Change in mothers' anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Week 1 and Week 14
measure: Change in mothers' stress assessed using the Parenting Stress Index- Short Form (PSI-SF)
timeFrame: Week 1 and Week 14
measure: Mothers' experience of childhood maltreatment assessed using the Childhood Trauma Questionnaire (CTQ)
timeFrame: Week 1
measure: Mothers' experience of childhood adversity assessed using the Adverse Childhood Experiences Scale (ACES)
timeFrame: Week 1
measure: Change in mothers' internalized stigma assessed using the Brief Opioid Stigma Scale (BOSS)
timeFrame: Week 1 and Week 14
measure: Change in mothers' internalized stigma assessed using the Substance Use Stigma Mechanism Scale (SU-SMS)
timeFrame: Week 1 and Week 14
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Studies Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Amanda Lowell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Helena Rutherford, PhD
role: PRINCIPAL_INVESTIGATOR
References: