Adults 18 to 40, female only, with Maternal Behavior or Maternal Addiction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).Primary· 50 minutes after administration of oxytocin or placebo
Brain activation (blood-oxygen level dependent \[BOLD\] signal) in response to reward-related cues (own \[O\] vs. unknown \[U\] infant happy faces).
Brain activation (BOLD signal) in response to stress-related cues (own \[O\] vs. unknown \[U\] infant sad faces).
Specific regions of interests include the striatum and amygdala (for both happy and sad faces).
Happy faces (O>U): Striatum
Group
Value
95% CI
Oxytocin
-.33
± .16
Placebo
.00678
± .14
Happy faces (O>U): Amygdala
Group
Value
95% CI
Oxytocin
-.25
± .16
Placebo
.16
± .15
Sad faces (O>U): Striatum
Group
Value
95% CI
Oxytocin
.34
± .14
Placebo
.04
± .13
Sad faces (O>U): Amygdala
Group
Value
95% CI
Oxytocin
.36
± .14
Placebo
.04
± .13
Effect of Intranasal Oxytocin on Brain fMRI Activation in Addicted vs Controls Mothers (Hypotheses 1 and 2B)Primary· 50 minutes after administration of oxytocin or placebo
Brain activation (BOLD signal) in response to reward-related cues (own \[O\] vs. unknown \[U\] infant happy faces). Specific region of interest includes the ventromedial prefrontal cortex (vmPFC) (interaction effect).
Brain activation (BOLD signal) in response to stress-related cues (own vs. unknown infant sad faces). Specific region of interest includes the dorsolateral prefrontal cortex (dlPFC) (interaction effect).
Happy faces (O>U): vmPFC
Group
Value
95% CI
Addicted - Oxytocin Condition
.00266
± 0.20
Control - Oxytocin Condition
-0.30
± 0.18
Addicted - Placebo Condition
0.20
± 0.18
Control - Placebo Condition
-0.11
± 0.18
Sad faces (O>U): dlPFC
Group
Value
95% CI
Addicted - Oxytocin Condition
0.48
± 0.20
Control - Oxytocin Condition
0.39
± 0.19
Addicted - Placebo Condition
0.06
± 0.19
Control - Placebo Condition
-0.02
± 0.18
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lane Strathearn, MBBS PhD
Last refreshed: 26 March 2025
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