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Neuroplasticity in Maternal Opioid Use Disorder (OUD)

StatusSuspended
PhaseNot applicable
Started2023-01-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
critical
Recruiting→Suspended Study Status, Contacts/Locations v6
Recruitment suspended: PI in transition, assessing feasibility of study continuation
Primary completion pushed: 2026-06 → 2026-12
Completion pushed: 2026-06 → 2026-12
Trial statusRecruiting→Suspended
Study sitesdetails revised at 1 of 1 site
2025-10-27
minor
Study Status v5
Primary completion date2025-09→2026-06
Completion date2025-09→2026-06
2025-02-18
minor
Study Status v4
Primary completion date2024-12-31→2025-09
Completion date2024-12-31→2025-09
2024-01-17
minor
Study Status, Study Description, Study Design, Outcome Measures v3
Primary completion date2024-08-31→2024-12-31
Completion date2024-08-31→2024-12-31
Enrollment target30→15
Secondary endpointsdetails revised at 7 of 9 entries
Study description-289 characters
[...] for OUD who are caring for infants who are 4-12 months old. 3015 mothers will complete 1 study visit, which will last 2.5 ho [...] ical measures (depression, anxiety, stressful life events). 15 of the 30 mothersParticipants will bethen recruited to participate in an additional 14 study visits (Visits 2-15) consisting of 1 additional pre-treatment data collection visit,complete 12 treatment (Mothering from the Inside Out (MIO)) visits, and 1 post-treatment data collection visit. VisitVisits 2 (1 hour) will start with informed consent for the additional visits and include a clinical intake and assessme [...] [...]
2023-02-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-12→confirmed 2023-01-01
Study sitesdetails revised at 1 of 1 site
2022-11-09
minor
Study Status v1
Start date2022-09→2022-12
2022-08-08
minor
Original filing
487 trials monitored
See 35 trials at risk
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.
Trial Details
NCT Number NCT05495984
Lead Sponsor Yale University
Collaborators: Alkermes, Inc.
Conditions Opioid Use Disorder
Enrollment 15 participants
Start Date 2023-01-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-14