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Experimental Study on Alcohol Use and Behavior in Young Adults

NCT06199076 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Joar Guterstam, PhD, M.D. · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2025-04-23
Completion
2025-04-23

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06199076 on ClinicalTrials.gov