RecruitingNAINTERVENTIONAL

High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction

This research is investigating a new treatment for alcohol addiction using a technique called Theta Burst Stimulation (TBS). It's a type of brain stimulation that aims to help reduce alcohol cravings and consumption. The study involves 72 people who want to cut down or stop drinking. Participants will be randomly assigned to one of two groups: one will receive the actual TBS treatment, and the other will receive a 'sham' or dummy treatment that feels similar but doesn't have the active effects. This helps researchers work out if the real treatment is effective. The study is for adults aged 18 to 65 living in Germany and speaking German. The goal is to see if this high-dose TBS can be a useful tool in helping individuals manage their alcohol dependence.

At a glance

Status

Recruiting

Phase

Sponsor

Berthold Langguth, MD, Ph.D.

Enrolment target

Start

01 Mar 2023

Estimated completion

28 Feb 2026

Alcohol Dependence

What is this study about?

This study is exploring a new way to help people who are struggling with alcohol addiction. It's called "high-dose accelerated intermittent Theta Burst Stimulation" – which sounds complicated, but it's a special type of brain stimulation. The idea behind it is to use magnetic pulses to gently stimulate specific areas of the brain that are thought to be involved in addiction. The hope is that by stimulating these areas, it might help to reduce cravings for alcohol or improve a person's ability to control their drinking.

The researchers want to find out if this treatment is effective. To do this, they are looking for 72 people with alcohol addiction who want to reduce or stop their drinking. Participants will be split into two groups by chance – like flipping a coin. One group will get the real brain stimulation treatment, and the other group will get a "sham" treatment. A sham treatment feels similar to the real one, but it doesn't actually deliver the active stimulation. This is important for researchers to be sure that any changes seen are due to the actual treatment and not just a placebo effect or expectation.

By comparing the results from both groups, the scientists can understand if this brain stimulation is a safe and helpful new option for people needing support with alcohol addiction. It’s part of a bigger effort to discover more effective ways to help people recover and improve their health.

Key takeaways

This study explores a new brain stimulation for alcohol addiction.
It aims to help reduce alcohol cravings and drinking.
72 participants will receive either active treatment or a dummy treatment.
Open to adults aged 18-65 in Germany who want to change their drinking.
Participation is voluntary, and you can withdraw anytime.
Results will help understand if this is a useful new treatment option.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and live in Germany, speaking German. You must have been diagnosed with alcohol dependence and want to reduce or stop your drinking. You'll also need to be able to understand the study information and give your written permission to take part.

There are some reasons why you wouldn't be able to join. For example, if you have certain metal implants or electronic devices in your body (like a pacemaker), as these can be affected by the magnetic stimulation. You also can't have any serious ongoing neurological (brain or nerve) or internal health problems, or have had this type of brain stimulation treatment before. If you're pregnant or breastfeeding, you won't be able to participate either.

Additionally, you can't be taking certain medications for alcohol addiction, or have recently had a positive alcohol breath test. If you have severe long-term mental health conditions like schizophrenia or bipolar disorder, or an acute mental health problem needing hospital care, you won't be suitable for this study. The researchers also need to be sure you can complete questionnaires and attend follow-up appointments.

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 between 18 and 65 years old?
Do you have a diagnosis of alcohol dependence and want to reduce or stop drinking?
Do you live in Germany and speak German?
Do you NOT have any pacemakers or metal implants in your body?
Are you NOT pregnant or breastfeeding?
Are you NOT currently taking certain specific medications for alcohol addiction?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either receive the active brain stimulation or a dummy (sham) treatment. The study will involve regular visits where you will receive your assigned treatment sessions. We don't have full details here on how many visits or how long each session lasts, but you can expect to spend time at the study site for these treatments. You will also be asked to complete questionnaires about your alcohol use and general well-being throughout the study and during follow-up periods. It's important to attend all scheduled appointments and complete the questionnaires accurately so researchers can gather reliable information. The total duration of your involvement, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by helping you reduce your alcohol use, or it might help researchers learn more about how to treat alcohol addiction, which could help others in the future. However, there's no guarantee the treatment will work for you, especially if you receive the dummy treatment. Potential risks of brain stimulation can include mild headaches or discomfort, though these are usually temporary. The study team will explain all known side effects. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Department of Psychiatry and Psychotherapy, University of Regensburg
Verified postcode
Regensburg, Germany· Recruiting

Common questions

What is Theta Burst Stimulation (TBS)?

TBS is a special type of brain stimulation that uses magnetic waves to gently affect certain areas of the brain. Doctors are studying if it can help with issues like addiction.

Why is there a 'sham' treatment group?

The sham group helps researchers compare the real treatment to a dummy one. This way, they can be sure if any improvements are truly from the TBS and not just because people expect to feel better.

Will I know if I'm getting the real treatment or the sham treatment?

No, you won't know which group you are in. This is called 'blinding' and it helps make sure the study results are fair and unbiased.

Do I need to stop drinking completely to be in the study?

The study is for people who want to reduce or stop their drinking, so you don't necessarily have to be completely sober at the start, but you must have a desire to change your drinking habits.

What if I change my mind after joining?

You are free to leave the study at any point, for any reason, without it affecting your ongoing medical care.

How to find out more

Martin Schecklmann, Prof.

martin.schecklmann@medbo.com +49-941-941-1256 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.