Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study

What Was Tested

The trial (phase 3) is built around Oxytocin.

This study is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year.

It is a follow-up study of a placebo-controlled randomized controlled study where subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an outpatient setting.

Half of the participants have received oxytocin nasal spray, the other half placebo nasal spray (NCT02903251).

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

Intranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel. Day 3-30:Self-administered intranasal spray as needed, max thrice daily.

Intranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel. Day 3-30: Self-administered intranasal spray as needed, max thrice daily.

The registry classes the interventions as drug and other.

Who Took Part

38 actual participants took part.

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

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

Examples of who could join: Participants in the RCT (NCT02903251) who completed the study.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: participants in the rct (nct02903251) who did not complete the study.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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, care provider, investigator and outcomes assessor.

It started in 2017-11-01 with completion listed for 2019-03-31.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Alcohol intake (time frame: 60 days). Alcohol intake (time frame: 1 year).

It also tracked 3 secondary outcomes, for example Sleep and Sleep.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 38 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.