Study on Oxytocin for Improving Behavior in Young Adults with Alcohol Use Disorder

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What is this study about?

This clinical trial is focused on studying Alcohol Use Disorder (AUD) in young adults. The study will explore the effects of a treatment using a nasal spray called Syntocinon, which contains the active substance oxytocin. Oxytocin is a naturally occurring hormone that is sometimes used in medical treatments. The trial will compare the effects of oxytocin to a placebo to see if it can increase prosocial behavior, which means actions that benefit others, in individuals with high alcohol use.

The purpose of the study is to understand if oxytocin can help improve social interactions in young adults who have high alcohol consumption. Participants will receive either the oxytocin nasal spray or a placebo during the study. The study will involve two visits where participants will be asked to complete tasks that measure their social behavior, impulsivity, emotion recognition, social learning, and alcohol craving. These tasks will help researchers understand the effects of the treatment on different aspects of behavior and emotions.

The study is designed to be completed over a short period, with participants attending two sessions. During these sessions, they will be monitored and asked to perform various tasks to assess changes in their behavior and emotional responses. The results of this study could provide valuable insights into new ways to support individuals with Alcohol Use Disorder in improving their social interactions and managing their alcohol use.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide informed consent, confirming your understanding and willingness to participate in the study.

You will undergo a screening process to ensure you meet the eligibility criteria, which includes being a male aged 18-24 with high alcohol use as defined by specific criteria.

2 first administration

You will receive the investigational medicinal product, which is a nasal spray containing oxytocin or a placebo. The spray is administered intranasally.

The dosage is 6.7 micrograms per dose. The effects will be monitored during the visit.

3 behavioral assessment

Approximately 35-75 minutes after administration, your prosocial behavior will be assessed using a task called the dictator game.

This task is designed to measure your willingness to share resources with others.

4 secondary assessments

Between 76-120 minutes after administration, additional assessments will be conducted. These include tasks to measure impulsivity, emotion recognition, social learning, and alcohol craving.

These tasks are designed to evaluate different aspects of behavior and response to the investigational product.

5 second visit

You will attend a second visit, where the same procedures will be repeated. This includes the administration of the nasal spray and the subsequent assessments.

The purpose of the second visit is to compare results and observe any changes in behavior or response.

Who Can Join the Study?

Must be between 18-24 years old
Must be male
Must be able to give informed consent and follow the study procedures
Must have a history of high alcohol use: Meets criteria for at least moderate Alcohol Use Disorder (AUD) in the past 12 months according to the MINI Neuropsychiatric Interview
Must score at least 8 points on the Alcohol Use Disorder Identification Test

Who Cannot Join the Study?

Individuals who do not have Alcohol Use Disorder (AUD) cannot participate.
Females are not eligible to participate in this study.
Individuals under the age of 18 or over the age of 65 are not eligible.
Individuals who are part of a vulnerable population are not eligible. A vulnerable population includes people who may have limited ability to protect their own interests.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Karolinska Institutet	Solna	Sweden

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

Oxytocin

Oxytocin is a hormone that is naturally produced in the body. It is often called the “love hormone” because it plays a role in social bonding, sexual reproduction, and during and after childbirth. In this clinical trial, oxytocin is being studied to see if it can help increase prosocial behavior, which means actions that benefit others, in individuals who have high alcohol use. The researchers want to find out if giving oxytocin can make people more likely to engage in positive social interactions.

Investigated diseases:

Alcohol use disorder

Alcohol Use Disorder (AUD) – Alcohol Use Disorder is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. It often begins with occasional drinking that gradually increases in frequency and quantity. Over time, individuals may develop a tolerance, needing more alcohol to achieve the same effects. As the disorder progresses, individuals may experience withdrawal symptoms when not drinking, such as anxiety, tremors, or nausea. The condition can lead to significant disruptions in daily life, affecting relationships, work, and overall well-being. It is a chronic condition that can vary in severity, with some individuals experiencing periods of remission and relapse.

Trial ID:

2022-501809-13-01

Trial Phase:

Therapeutic exploratory (Phase II)

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