Oxytocin and Brain Responses in Maternal Addiction

NCT02979093 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-03-26

Study results available
· View outcomes & findings →

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

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02979093 on ClinicalTrials.gov