Oxytocin and Brain Responses in Maternal Addiction

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

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.

It had two arms (groups): Addicted (other) and Control (other).

The addiction group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.

The control group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.

The registry classes the interventions as drug and procedure.

More on the Plan

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.

Who Took Part

The registry lists 59 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Are being evaluated for treatment of their addiction or are currently enrolled in treatment programs;. Have an infant \<12 months;. Meet criteria for substance abuse or dependence in the past year, as assessed by MINI International Neuropsychiatric Interview (MINI);. Have a substance abuse history, including use during the most recent pregnancy;. Are recommended at intake for drug-treatment services for substance abuse;.

The full record lists 11 inclusion and 27 exclusion criteria; among the exclusions: past or present diagnosis of schizophrenia or other psychotic disorders;; metal implants or other contraindications for mri scanning;; pending legal cases (e.g., outstanding arrest warrants or parental rights hearings) prohibiting them from completing the study;.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-05-05 with completion listed for 2021-05-17.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A) (time frame: 50 minutes after administration of oxytocin or placebo). Effect of Intranasal Oxytocin on Brain fMRI Activation in Addicted vs Controls Mothers (Hypotheses 1 and 2B) (time frame: 50 minutes after administration of oxytocin or placebo).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 59 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.