Understanding brain changes in mothers with opioid use disorder
Neuroplasticity in Maternal Opioid Use Disorder (OUD)
NA · Yale University · NCT05495984
This study is testing if a special program can help mothers with opioid use disorder improve their mental health and caregiving skills while also looking at changes in their brain activity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05495984 on ClinicalTrials.gov |
What this trial studies
This study focuses on mothers with opioid use disorder (OUD) who are caring for infants aged 4 to 12 months. It aims to explore maternal neuroplasticity through high-dense array electroencephalography (EEG) and assess the impact of an evidence-based intervention called Mothering from the Inside Out (MIO). Participants will undergo a series of assessments and treatment visits designed to enhance their caregiving experience and improve mental health outcomes. The study will evaluate changes in neural circuitry related to stress regulation and reward processes in response to the intervention.
Who should consider this trial
Good fit: Ideal candidates are biological mothers aged 21-45 with infants between 4-12 months who are enrolled in substance use treatment and receiving medication for opioid use disorder.
Not a fit: Patients who are non-English speaking, unable to provide informed consent, or have physiological addiction requiring detoxification may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for mothers with OUD, enhancing their ability to care for their infants.
How similar studies have performed: While the specific intervention has not been formally tested, similar approaches targeting neuroplasticity in maternal populations have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New Haven, Connecticut
- Yale Child Studies Center — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Amanda Lowell, Ph.D. — Yale University
- Study coordinator: Amanda Lowell, PhD
- Email: amanda.lowell@yale.edu
- Phone: 321-277-2516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder