Oxytocin and Alcohol Withdrawal and Dependence

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting.

Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.

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.

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

40 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: Average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;. Consenting to participate in the study;. Have residency in Trøndelag County after discharge.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: dependence on substances other than alcohol, nicotine or caffeine;; low body weight (bmi \< 17) or history of anorexia nervosa or bulimia in the past 2 years;; pregnancy; parturition or breast-feeding in the past 6 months;.

How the Study Was Run

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

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

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 2016-10 with completion listed for 2018-01-22.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Alcohol intake (time frame: 30 days).

It also tracked 15 secondary outcomes, for example Sleep, Sleep, motor activity, alcohol craving, alcohol craving and Mental distress.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 40 people.

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.