Oxytocin Treatment of Alcohol Dependence

What Was Tested

This registered phase 2 trial tested Oxytocin.

It had two arms (groups): Intranasal oxytocin spray (Syntocinon Spray) (active comparator) and Intranasal Placebo Spray (placebo comparator).

TID inpatient; BID outpatient for 12 wks.

TID inpatient; BID outpatient for 12 wks.

The registry classes the interventions as drug.

More on the Plan

Study Design This is a randomized, double blind, placebo-controlled early phase II clinical trial.

Recruitment: The study has 2 phases.

The first is testing intranasal treatments (oxytocin \[OT\], placebo) on alcohol withdrawal (the inpatient phase) and the second is testing intranasal treatments on alcohol drinking, craving and anxiety over 12 weeks in the outpatient setting (the outpatient phase).

Subjects in the inpatient phase of the study at FRH may continue into the outpatient phase after discharge.

Who Took Part

13 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Inclusion Criteria for the inpatient phase (alcohol withdrawal treatment) of the study.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: exclusion criteria for the inpatient alcohol withdrawal treatment phase of the study; 1\. history of alcohol withdrawal-related seizures, delirium tremens or hallucinations; 4\. chronic or subchronic ( \>3 days in the week prior to admission or outpatient enrollment) treatment with/consumption of benzodiazepines, barbiturates, anticonvulsants or stimulants.

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.

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, care provider, investigator and outcomes assessor.

It started in 2013-01 with completion listed for 2013-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score.

It also tracked 2 secondary outcomes, for example Total mg of Lorazepam for Detoxification and Change in Percentage Heavy Drinking Days.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 13 people.

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

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.