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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: Recruiting NA study of Opioid Use Disorder, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes. Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. Net Station 4.5 will be used to pre-process EEG data (first be digitally filtered, then segmented into 1-second epochs (100ms pre- and 900ms post-stimulus onset). Net Station artifact detection will be set to detect artifact. Spline interpolation will be used to replace channels with artifacts
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 |
What NCT05495984 shows while recruiting
NCT05495984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05495984's enrollment target sits among peer trials
15 242nd of 257 higher than 11 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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