Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Experimental Study on Alcohol Use and Behavior in Young Adults

This research study is about understanding how two different nasal sprays might impact the behaviour of young men, particularly those who experience alcohol use disorder. The study aims to look at whether these sprays can change how people interact with others in social situations and how they make choices. Participants will receive one of the nasal sprays during visits and researchers will observe their behaviour using specific tasks and games. They will also measure things like impulsivity, how well people recognise emotions, and how they learn. This is an early-stage study (Phase II) meaning it's an important step in exploring new ways to help people with alcohol-related issues, by understanding the effects of these potential treatments on behaviour.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Karolinska Institutet

Enrolment target

220

Start

17 May 2023

Alcohol Use Disorder (AUD)

What is this study about?

This study is called an "Experimental Study on Alcohol Use and Behavior in Young Adults." In simple terms, it's a research project exploring how specific nasal sprays might influence the behaviour of young men who have been diagnosed with Alcohol Use Disorder (AUD). AUD is a health condition where someone has trouble controlling their drinking, leading to problems in their daily life.

The researchers want to see if these nasal sprays, named Renässans Naturell Nässpray and Syntocinon 6, change how young men act and make decisions. They are particularly interested in "prosocial behaviour," which means how people behave in ways that benefit others. For example, they'll use a type of game where participants decide how to share money to see if the sprays have an effect.

Beyond just social behaviour, the study also looks at other important aspects like impulsivity (acting without thinking), how well people recognise emotions in others, and how they learn socially. They'll also check if the sprays affect cravings for alcohol. This is a Phase II study, which means it's an important early step to see if these treatments have a hopeful effect and are worth exploring further before being widely used.

Key takeaways

This study is for men aged 18 and over with Alcohol Use Disorder.
It investigates how two nasal sprays might affect social behaviour and decision-making.
Participation involves two study visits with specific tasks and games.
It's an early-stage research study, not a new approved treatment.
You have the right to leave the study at any point if you choose.

Who may be eligible?

To be considered for this study, you must be a male and at least 18 years old. There is no upper age limit, meaning men of any age 18 and above can potentially take part if they meet other criteria.

It's important to remember that these are just the basic requirements. The research team will have a more detailed list of things they look for, which includes specific health information and other factors related to having Alcohol Use Disorder. They need to ensure that the study is safe for you and that the results will be accurate and helpful.

If you're a man aged 18 or over and have Alcohol Use Disorder, and you're interested in learning more, you should discuss this study with your doctor. They can help you understand if you might be a good fit and can provide more specific details about the full eligibility criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you male?
Are you 18 years old or older?
Have you been diagnosed with Alcohol Use Disorder (AUD)?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll need to visit the study site at least twice. During these visits, which will be 35-75 minutes after you use one of the nasal sprays, you'll play a game called a "dictator game." This game helps researchers understand social behaviour. For another period, 76-120 minutes after using the spray, you'll complete other tasks to check your impulsivity, how you recognise emotions, how you learn socially, and if you have any alcohol cravings. The duration of each visit and the overall length of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as contributing to scientific understanding that might help others with Alcohol Use Disorder in the future. You might also learn more about your own behaviour through the tasks. However, there are also potential risks; the nasal sprays might cause side effects, or you might find the tasks challenging. The study team will explain all known risks to you before you agree to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is Alcohol Use Disorder (AUD)?

AUD is a medical condition where a person has difficulty controlling their drinking, which can lead to problems in their daily life, relationships, and health.

What are "nasal sprays" in this study?

The study is testing two different nasal sprays, Renässans Naturell Nässpray and Syntocinon 6. These are being investigated for their potential effects on behaviour.

What is a "dictator game"?

It's a simple game used in research where one person decides how to share an amount of money with another person. It helps researchers understand social decision-making.

Is this a new treatment?

This is an early-stage study (Phase II), meaning researchers are exploring if these treatments have a hopeful effect on behaviour related to AUD. They are not yet approved treatments.

Will I know which nasal spray I'm getting?

Often in studies like this, participants don't know which specific treatment they are receiving until after the study is over, to ensure unbiased results. The researchers will explain how this works.