Oxytocin and Brain Responses in Maternal Addiction
NCT02979093 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2025-03-26
Summary
A prior study by the principal investigator of this project identified dopamine- and oxytocin-related brain pathways that showed a diminished response when addicted mothers viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These areas include the hypothalamus, striatum and ventromedial prefrontal cortex. In addition, the investigators plan to examine activation patterns within the salience network, which includes the anterior cingulate cortex and the anterior insula. Oxytocin, a neuropeptide with decreased blood levels seen in addicted mothers, is integrally involved in maternal brain and behavioral responses. When administered intranasally, the pilot data has shown enhanced activation of the striatum, prefrontal cortex (PFC) and amygdala.
The purpose of this study is to continue and expand upon the previous investigation of maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate in four study visits over a two-month period.
Conditions
- Maternal Behavior
- Maternal Addiction
Interventions
- DRUG
-
Oxytocin
All women will receive a nasal spray containing oxytocin.
- DRUG
-
Placebos
All women will receive a nasal spray containing a placebo solution.
- PROCEDURE
-
Functional MRI scanning
Study participants undergo two functional MRI scans.
Sponsors & Collaborators
-
Yale University
collaborator OTHER -
Lane Strathearn, MBBS PhD
lead OTHER
Principal Investigators
-
Lane Strathearn, MBBS PhD · University of Iowa
-
Linda Mayes, MD · Yale University
-
Helena Rutherford, PhD · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-05
- Primary Completion
- 2021-05-17
- Completion
- 2021-05-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
The Correlation Between Maternal Infant Bonding, Pain and Postpartum Depression
NCT05206552 ·Status: UNKNOWN
-
Neurobiological Bases of Paternal Nurturance
NCT02223429 ·Status: COMPLETED ·Phase: NA
-
Neuroplasticity in Maternal Opioid Use Disorder (OUD)
NCT05495984 ·Status: RECRUITING ·Phase: NA
-
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
NCT05830266 ·Status: RECRUITING ·Phase: NA
-
Preventing Postpartum Depression With Intranasal Oxytocin
NCT02505984 ·Status: COMPLETED ·Phase: PHASE2
-
The Effect of Early Dyadic Psychotherapy for Mothers Suffering From PPD on Oxytocin Level and on Childrens' Emotional Development
NCT04138368 ·Status: UNKNOWN ·Phase: NA
-
Can Oxytocin Level Predict Postpartum Depression?
NCT02020148 ·Status: COMPLETED
-
Relationship-Based Intervention for Post-Partum Depression
NCT04193462 ·Status: RECRUITING ·Phase: NA
-
Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition
NCT01762943 ·Status: COMPLETED ·Phase: NA
-
Motivating Our Mothers 2
NCT02938598 ·Status: COMPLETED ·Phase: NA
-
Maternal Marijuana Use and Fetal and Infant Outcome
NCT04266314 ·Status: WITHDRAWN
-
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
NCT06576323 ·Status: RECRUITING ·Phase: NA
-
Prenatal Depression Prevention Effects on Parenting and Young Child Self-Regulation and Functioning
NCT04296734 ·Status: COMPLETED
-
Parental Stress During the COVID-19 Pandemic and Its Association With Depression and Anxiety
NCT04377074 ·Status: COMPLETED
-
Mother-Baby Study - Observational
NCT06039878 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Studies of Mothers With Postnatal Depression
NCT04745494 ·Status: COMPLETED ·Phase: NA
-
Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
NCT03464630 ·Status: COMPLETED ·Phase: NA
-
Night Respite for Postpartum Mothers With SUD
NCT05746507 ·Status: COMPLETED ·Phase: NA
-
The Effect of Traumatic Childbirth on the Incidence of PTSD and Other Major Postpartum Psychopathology
NCT02370576 ·Status: UNKNOWN
-
Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.
NCT03567070 ·Status: COMPLETED ·Phase: NA
-
Determining Relationships Among Maternity Stress & Sleep
NCT02133963 ·Status: COMPLETED
-
Mindful Moms in Recovery
NCT04584502 ·Status: COMPLETED ·Phase: NA
-
Mother-infant Bonding During COVID-19
NCT04531618 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Sleep, Oxytocin and Reward Processing in Women in the Postpartum Phase
NCT06711809 ·Status: NOT_YET_RECRUITING
-
The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults
NCT02225600 ·Status: SUSPENDED ·Phase: NA