Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

What Was Tested

This registered phase 1 trial tested Oxytocin.

This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD).

Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial.

Participants will complete an 7-day inpatient protocol.

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

Intranasal placebo administered 3 times daily for 1 week.

The registry classes the interventions as drug.

More on the Plan

This study will lay the necessary groundwork for future comprehensive research to examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD).

OT modulates a number of key systems involved in addiction processes, including dopamine (DA) mesolimbic reward circuitry, and hypothalamic-pituitary-adrenal (HPA) axis and corticotrophin-releasing factor (CRF) stress systems, and has low abuse liability.

Their overarching hypothesis is that OT will attenuate several measures thought to drive compulsive alcohol drinking and relapse.

Since interactions with alcohol are an important focus of their study, investigators will enroll non-treatment seeking heavy drinkers with AUD in a double blind, placebo controlled inpatient protocol.

Who Took Part

The registry lists 27 actual participants took part.

It was open to people of any sex aged from 21 years up to 50 years.

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

Examples of who could join: Healthy 21-50 years old male and female subjects. Must meet Diagnostic and Statistical Manual (DSM) -V criteria for AUD and not be seeking treatment. Positive blood phosphatidylethanol (PEth) blood test.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: drug use in last 30 days and/or positive urine toxicology screens (excluding marijuana); history of seizure disorder or closed head trauma; history of withdrawal-related seizures or serious alcohol withdrawal symptoms.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2015-03 with completion listed for 2017-06-15.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Alcohol drinking (time frame: 1 day).

It also tracked 3 secondary outcomes, for example alcohol effects, side effects and Salivary cortisol.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 27 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.