Actively Recruiting
Neuroplasticity in Maternal Opioid Use Disorder (OUD)
Led by Yale University · Updated on 2025-10-29
15
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
A
Alkermes, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neuroplasticity in Maternal Opioid Use Disorder (OUD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biological mother of infants between 4 months and 12 months of age
- Age between 21 and 45 years at time of recruitment
- Enrolled in substance use treatment and receiving medication for opioid use disorder (MOUD)
You will not qualify if you...
- Unable to give informed consent
- Child spends less than 50% of time in mother's custody
- Non-English-speaking
- Unable to complete the study due to pending legal cases or inability to provide two forms of contact for follow-up
- Physiological addiction requiring detoxification, such as severe withdrawal symptoms (e.g., delirium tremens, shaking, nausea)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale Child Studies Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
A
Amanda Lowell, PhD
CONTACT
H
Helena Rutherford, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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