Actively Recruiting

Phase Not Applicable
Age: 21Years - 45Years
FEMALE
NCT05495984

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

Age: 21Years - 45Years
FEMALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Yale Child Studies Center

New Haven, Connecticut, United States, 06520

Actively Recruiting

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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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Neuroplasticity in Maternal Opioid Use Disorder (OUD) | DecenTrialz