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Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness

Plain-language guide to NCT06332066: phase 1 randomized trial of Oxytocin, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06332066
Phase
phase 1
Status
status unknown
Start
2024-05-01
Completion (planned or actual)
2024-05-30
Participants
20 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Mental Health Therapists
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad.

Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted.

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

The registry classes the interventions as drug.

More on the Plan

One of these compounds is Oxytocin (OT), a nine-amino acid neuropeptide generated in the hypothalamus and released by the pituitary gland (Brownstein et al., 1980).

Nonetheless, in a recent study conducted by Grossman-Giron et al.

One biobehavioral model which can explain the compelling evidence found in Grossman-Giron et al.

(2021) is the putative role of OT in the activation of the caregiving system of the therapist.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 99 years.

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

How the Study Was Run

Design: randomized, sequential and triple-blind.

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2024-05-01 with completion listed for 2024-05-30.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Attunement and Responsiveness towards patients (time frame: 3 weeks).

It also tracked 3 secondary outcomes, for example Attachment with Therapist, Working Alliance with Therapist and Patient Symptoms.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.