MedPath

Alcohol Use and Behavior in Young Adults

Phase 1
Conditions
Alcohol Use Disorder (AUD)
Therapeutic area: Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
Registration Number
CTIS2022-501809-13-01
Lead Sponsor
Karolinska Institutet
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Male
Target Recruitment
220
Inclusion Criteria

18-24 years of age, Male, Give informed consent and comply with study procedure, High alcohol use individuals: Fulfils criteria for at least moderate AUD the past 12 months according to MINI Neuropsychiatric Interview, High alcohol use individuals: Fulfils at least 8 points on the Alcohol Use Disorder Identification Test

Exclusion Criteria

Fulfils criteria for any substance use disorder (except AUD for High Alcohol-group, and mild cannabis- and nicotine use disorder for both groups)., History of severe psychiatric disorder (e.g. severe depression, bipolar, antisocial personality disorder) or neuropsychiatric disorder of ADHD, autism or Tourette’s., Using intranasal medicine that could not be stopped 48 hours prior to each visit, Allergy or intolerance to preservatives in nasal spray, e.g. latex allergy., Upper-respiratory tract infection (i.e. a ‘common cold’ resulting in significant nasal congestion) at day of testing (but with the possibility of rescheduling for another time point)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Does oxytocin (compared to placebo) for individuals with high alcohol use increase prosocial behavior?;Secondary Objective: Does oxytocin (compared to placebo) for individuals with high alcohol use increase emotion recognition and reduce alcohol craving?;Primary end point(s): Prosocial behavior using a dictator game task measured at both study visits 35-75 minutes after administration of the investigational medicinal product.
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s):Impulsivity using a delay discounting task, emotion recognition using an emotion recognition task, social learning using an observational fear learning task, and alcohol craving using an alcohol cue-craving task measured at both visits 76-120 minutes after administration of the investigational medicinal product.
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