Neuroplasticity in Maternal Opioid Use Disorder (OUD)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 45
Healthy Volunteers: f
View:

• 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).

Locations
United States
Connecticut
Yale Child Studies Center
RECRUITING
New Haven
Contact Information
Primary
Amanda Lowell, PhD
amanda.lowell@yale.edu
321-277-2516
Backup
Helena Rutherford, PhD
helena.rutherford@yale.edu
203-737-3408
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-09
Participants
Target number of participants: 15
Treatments
Experimental: 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
Experimental: 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).
Related Therapeutic Areas
Sponsors
Collaborators: Alkermes, Inc.
Leads: Yale University

This content was sourced from clinicaltrials.gov