Experimental Study on Alcohol Use and Behavior in Young Adults

What Was Tested

This registered phase 2 trial tested Oxytocin.

The goal of this double blind randomized placebo-controlled clinical trial is to compare intranasal oxytocin and placebo in young adult individuals with alcohol use disorder as compared to healthy controls.

The main questions it aims to answer are: * The effect of oxytocin versus placebo on prosocial behavior in individuals with high- versus low alcohol use * The effect of oxytocin versus placebo on impulsivity, emotion recognition, social learning, and alcohol craving in individuals with high- versus low alcohol use Participants in both groups will on two separate visits perform the following validated behavioral task measures: * Dictator game tasks assessing prosocial behavior * Delay discounting task assessing impulsivity * Emotion recognition task assessing emotion recognition * Alcohol cue craving task assessing alcohol craving * Observational fear learning task assessing social learning Researchers will compare groups of high and low alcohol use to see if there is a difference in effect of oxytocin versus placebo between groups.

It had four arms (groups): Oxytocin/Placebo, Alcohol Use Disorder (experimental), Placebo/Oxytocin, Alcohol Use Disorder (experimental), Oxytocin/Placebo, Healthy Control (experimental) and Placebo/Oxytocin, Healthy Control (experimental).

The registry classes the interventions as drug.

More on the Plan

HC Material and Methods: The study will include young adults (18-24 years old): 110 individuals with AUD and 110 healthy controls (HC) matched on gender, education, and age.

Sample size estimation is based on effect sizes from previous studies investigating prosocial behavior in addiction, and studies on the influence of OXT on social cognition respectively.

Both groups will undergo thorough psychiatric assessment before inclusion and eligible participants will be invited to a two-session laboratory study (2 weeks apart) randomized for the order of administration of the study compound.

Behavioral tasks previously developed in their laboratory and evaluated in AUD populations to identify social cognitive impairments in terms of prosocial behavior and emotion recognition will be utilized.

Who Took Part

206 actual participants took part.

It was open to men only aged from 18 years up to 24 years.

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

Examples of who could join: 18-24 years of age. Give informed consent and comply with study procedure. Understands written Swedish. Fulfils criteria for at least moderate AUD the past 12 months according to MINI Neuropsychiatric Interview. Fulfils at least 8 points on the Alcohol Use Disorder Identification Test.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: fulfils criteria for any substance use disorder (except aud for aud-group, and mild cannabis- and nicotine use disorder for both groups); using cocaine, amphetamines, hallucinogens, benzodiazepines, etc. within 1 month of the start of the study (excluding cannabis); cannabis use more than 2 days in past month.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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

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

It started in 2023-10-17 with completion listed for 2025-04-23.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Prosocial behavior using a brief 2-trial dictator game task measured at both study visits (time frame: 35-45 minutes after administration of the investigational medicinal product). Prosocial behavior using an extended dictator game task measured at both study visits (time frame: 46-65 minutes after administration of the investigational medicinal product).

It also tracked 4 secondary outcomes, for example Impulsivity using a delay discounting task task measured at both study visits, Emotion recognition using an emotion recognition task measured at both study visits, Alcohol craving using an alcohol cue-craving task measured at both study visits and Social learning using an observational fear learning task measured at both study visits.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 206 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.