Experimental Study on Alcohol Use and Behavior in Young Adults

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• 18-24 years of age

• Male

• Give informed consent and comply with study procedure

• Understands written Swedish

Alcohol use disorder (AUD) group

• 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

Healthy control group

• No criteria for AUD the past 12 months according to MINI Neuropsychiatric Interview

• Fulfils less than 8 points on the Alcohol Use Disorder Identification Test

Exclusion Criteria:

• 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

• Cannabis use on day of testing or day before testing

• Traces of alcohol as measured by breathalyzer on the day of testing

• History of severe psychiatric disorder (e.g. severe depression, bipolar, antisocial personality disorder) or neuropsychiatric disorder of ADHD, autism or Tourette's.

• Medical conditions of such severity that they require continual clinical attention, such as regular follow-up visits, prescribed medications or other specific treatment

• Prescription medicine the past 3 months

• Using non-prescription medicine that could not be stopped 48 hours prior to each visit

• Using intranasal medicine that could not be stopped 48 hours prior to each visit

• Prescription medicine the past 3 months

• 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)

• History of nasal disease (e.g. atrophic rhinitis, recurrent nose bleeds), nose damage (e.g. broken nose), and nasal surgery

• History of head trauma (i.e. loss of consciousness longer than 2 minutes)

• Simultaneous participation in another clinical trial