NCT05495984 Neuroplasticity in Maternal Opioid Use Disorder (OUD)
| NCT ID | NCT05495984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2023-01-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Amanda Lowell, Ph.D.
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05495984 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 45 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05495984 currently recruiting?
Yes, NCT05495984 is actively recruiting participants. Contact the research team at amanda.lowell@yale.edu for enrollment information.
Where is the NCT05495984 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05495984 clinical trial?
NCT05495984 is sponsored by Yale University. The principal investigator is Amanda Lowell, Ph.D. at Yale University. The trial plans to enroll 15 participants.