NCT02979093

Oxytocin and Brain Responses in Maternal Addiction

Oxytocin and Brain Reward and Stress Responses to Infant Cues in Addicted Mothers

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Lane Strathearn, MBBS PhD · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Maternal drug addiction constitutes a major public health problem for both women and affected children, with long lasting consequences on children's social, emotional and cognitive development. Current treatment strategies tend to focus on the mother and her current addiction, rather than her relationship with her child, and developmental processes that may perpetuate the addiction problems, such as unresolved childhood attachment trauma, neglect, and chronic stress. Unlike mothers who find engaging with their own infant to be a uniquely rewarding experience, mothers with addictions may be less able to respond appropriately to their infant's cues, finding them less intrinsically rewarding or salient, and more stress provoking. Aim 1: To examine, in addicted mothers compared to non-addicted control mothers, the effect of intranasal oxytocin (OT) on functional MRI brain responses to reward-related cues: own vs. unknown happy infant faces. Aim 2: To examine, in addicted mothers compared to non-addicted control mothers, the effect of intranasal OT on brain responses to stress-related cues: own vs. unknown sad infant faces and cries. Aim 3: To examine the effect of intranasal OT on functional brain connectivity, including the striatum, PFC and amygdala. Specifically, exploring whether, after receiving intranasal OT compared to placebo, addicted mothers show increased functional connectivity between the amygdala and (i) the ventromedial PFC for own-happy infant faces, and (ii) the dorsolateral PFC and striatum for own-sad faces. Aim 4: To explore how individual differences in adult attachment and mother-infant synchrony, sensation-seeking/risk-taking and stress/trauma exposure are associated with OT brain responses to infant faces. Aim 5: To examine the effect of intranasal OT on activation of the salience network in addicted mothers, as well as connectivity patterns between these regions and the amygdala. We predict that there will be noticeable increase in activity in the salience network (dorsal anterior cingulate and anterior insula) after administering OT. We predict the addiction group will have a greater affect from the OT treatment than the control group.

Conditions

• Maternal Behavior
• Maternal Addiction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-05
• Primary completion: 2021-05-17
• Completion: 2021-05-17
• First posted: 2016-12-01
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study