NCT06199076

Experimental Study on Alcohol Use and Behavior in Young Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Male
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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.

Detailed description

Hypotheses: 1. OXT vs. placebo will improve the deficits in prosocial behavior in individuals with AUD vs. HC, 2. OXT vs. placebo will improve the deficits in impulsivity, difficulties in emotion recognition and social learning in AUD vs. HC 3. OXT vs. placebo will reduce craving for alcohol, in individuals AUD vs. 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. On the planned test day after controlling for alcohol and drug use, intranasal OXT and matching placebo at a dose of 24IU will be administered. Behavioral tasks previously developed in our laboratory and evaluated in AUD populations to identify social cognitive impairments in terms of prosocial behavior and emotion recognition will be utilized. In addition, validated behavioral measure of impulsivity, namely the Delay discounting task will be used and craving will be assessed by a standardized assessment battery developed by our laboratory which includes a combination of a standardized questionnaire and visual cues comprising images of alcohol and people drinking.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Oxytocin nasal spray	The clinical trial is a phase II-study double-blind placebo-controlled study. The trial will have a parallel group cross-over design where subjects with alcohol use disorder versus healthy controls will administer a single dose of intranasal oxytocin versus placebo on two study visits 1-3 weeks apart.

Timeline

• Start date: 2023-10-17
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2024-01-10
• Last updated: 2025-05-07

Locations

1 site across 1 country: Sweden