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NCT05495984 · ClinicalTrials.gov registry record · NA
Neuroplasticity in Maternal Opioid Use Disorder (OUD)
A NA study of Opioid Use Disorder, sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05495984 is a NA study of Opioid Use Disorder that is actively recruiting participants, run by Yale University. The registered enrollment target is 15 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05495984, a NA study of Opioid Use Disorder, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL ERPs with electroencephalography (EEG)
- BEHAVIORAL MIO
Study Locations (1)
Connecticut
- Yale Child Studies Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05495984
The ClinicalTrials.gov registry entry for NCT05495984 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which ERPs with electroencephalography (EEG) is the first listed.
NCT05495984 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT05495984 about?
NCT05495984 is a clinical study titled "Neuroplasticity in Maternal Opioid Use Disorder (OUD)". 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 in...
What is the current status of trial NCT05495984?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2023-01-01. Estimated completion is 2026-06.
What conditions does trial NCT05495984 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT05495984?
The interventions under investigation include: ERPs with electroencephalography (EEG) (BEHAVIORAL), MIO (BEHAVIORAL).
Who is sponsoring clinical trial NCT05495984?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05495984 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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