Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

What Was Tested

This registered phase 1 trial tested Oxytocin.

All information collected is confidential.

It had two arms (groups): Syntocinon treatment (experimental) and Placebo (placebo comparator).

Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: 3-6 months postpartum at start of testing. Cocaine use during current pregnancy (by self-report or medical record of prenatal urine toxicology). Exclusive Formula-feeding for all infant milk feedings (no infant feeds will be breast milk). Healthy singleton pregnancy. English fluency that will allow informed consent.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: pregnancy or plans to become pregnant during participation in the study; breastfeeding for any infant milk feedings; mother is not currently living with the infant during the trial period.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-05 with completion listed for 2023-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 31 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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