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Oxytocin, Alcohol Craving, and Intimate Partner Aggression

Plain-language guide to NCT03046836: phase 2 randomized trial of Oxytocin, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03046836
Phase
phase 2
Status
completed
Start
2017-07-01
Completion (planned or actual)
2021-04-11
Participants
200 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Alcohol Use
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

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

Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur.

The neuropeptide oxytocin may help mitigate both AUD and IPA.

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

Each participant will self-administer matching saline placebo.

The registry classes the interventions as drug.

Who Took Part

200 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Inclusion criteria indicate that participants must. Aged 18 or over. Fluent in English. Endorse at least one instance of mild or moderate physical IPA with their partner in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2). Both partners must be willing to participate.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: exclusion criteria include; pregnancy or breastfeeding; body max index (bmi) ≥ 39.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 and investigator.

It started in 2017-07-01 with completion listed for 2021-04-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Alcohol Craving. Laboratory Intimate Partner Aggression Intensity (IPA) (time frame: 10 minutes from start to end of TAP). Laboratory Intimate Partner Aggression (IPA) Duration (time frame: 10 minutes from start to end of TAP).

It also tracked 2 secondary outcomes, for example Change in Cortisol and Change in Subjective Aggression.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 200 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.