RecruitingNAINTERVENTIONAL

Neuromodulation and Mindfulness Patients With AUD

This study is exploring new methods to help individuals who have stopped drinking alcohol to stay sober. It combines two non-invasive brain stimulation techniques with a special mindfulness program designed to prevent relapse. Called "mindfulness-based relapse prevention," this program already teaches people skills to cope with alcohol cravings. Researchers want to see if adding these gentle brain stimulation methods can make the mindfulness program even more effective. They will look at how cravings change, how much alcohol is consumed, and if people remain abstinent for up to three months after the treatment. The overall goal is to understand if these new approaches can help people maintain their recovery for longer.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

140

Start

20 Mar 2024

Estimated completion

30 Jun 2027

Alcohol Dependence

What is this study about?

This study is for people who have been diagnosed with alcohol dependence and have recently stopped drinking. We know that staying sober can be really challenging, and many people look for extra support.

This research is trying out a combination of two new approaches with a well-known program called 'mindfulness-based relapse prevention' (MBRP). MBRP teaches you how to be more aware of your thoughts and feelings, especially those that might trigger a desire to drink, and how to cope with them in healthy ways. The new approaches involve gentle, non-invasive ways to stimulate certain parts of the brain. One is called 'transcutaneous vagus nerve stimulation' (tVNS), which sends mild electrical pulses to a nerve in your neck. The other involves sending gentle electrical waves to your head to influence brain activity.

The main idea is to see if these gentle brain stimulation techniques, when used alongside mindfulness, can make the MBRP program even better at helping people avoid relapse. Researchers will be looking closely at how these methods might change the way your brain responds to cues that might make you want to drink, and how they affect your overall drinking habits, cravings, and ability to stay sober for several months after the study.

Key takeaways

New study to help people stay sober after stopping alcohol.
Combines mindfulness with gentle non-invasive brain stimulation.
Aims to make relapse prevention programs more effective.
Will track cravings and drinking habits for up to 3 months.
Open to those aged 18-70 who are recovering from alcohol dependence.

Who may be eligible?

To be considered for this study, you must have been diagnosed with alcohol dependence. You also need to have stopped drinking alcohol recently, sometime between 3 days and 12 months ago.

If you have other substance use disorders (besides alcohol) that have occurred in the last year, or if you have certain neurological problems like epilepsy or multiple sclerosis, this study might not be right for you. It's also not suitable if you currently have severe depression, manic episodes, or schizophrenia.

Finally, if you are taking certain strong medications for seizures or specific types of mental health conditions, you wouldn't be able to join. You need to be between 18 and 70 years old, and anyone, male or female, can participate.

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.

Have you been diagnosed with alcohol dependence?
Have you stopped drinking alcohol between 3 days and 12 months ago?
Are you between 18 and 70 years old?
Do you have any other substance use disorders in the last year?
Do you have neurological conditions like epilepsy or multiple sclerosis?
Are you currently taking strong medications for seizures or certain mental health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will take part in a structured mindfulness program. Some participants will also receive gentle brain stimulation either through a small device placed on your neck or on your head during some of the mindfulness exercises. Researchers will regularly check in with you to understand any changes in your drinking behaviour and cravings. This will involve answering questions and possibly some other assessments. The study will monitor your progress for up to three months after the main treatment period to see how well these approaches are working over time.

Potential risks and benefits

Participating in this study might offer you new strategies to manage alcohol cravings and prevent relapse, potentially improving your long-term recovery. It's important to know that, like any research, there might be some mild, temporary side effects from the brain stimulation, such as slight skin irritation or discomfort, though these are generally rare and not serious. Researchers will explain all potential risks in detail. Remember, you can choose to leave 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.

Charité - Berlin University of Medicine
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is mindfulness-based relapse prevention?

It's a program that teaches you mental skills, like focusing on the present moment, to help you cope with cravings and avoid going back to drinking alcohol.

What is brain stimulation in this study?

It involves very gentle electrical signals either near a nerve in your neck or on your scalp, aiming to help your brain respond better to mindfulness practices.

Will I have to stop my current treatment?

The study doesn't mention stopping current treatments. You should discuss all your current medications and therapies with the research team to ensure it's safe for you to participate.

How long will I be involved in the study?

You will participate in the main treatment program, and then your progress will be followed for up to three months afterwards.

Is this a new treatment, or is it proven?

This study is testing new combinations of existing approaches. It aims to see if combining brain stimulation with mindfulness makes the treatment more effective than mindfulness alone.

How to find out more

Annika Rosenthal

annika.rosenthal@charite.de 030 450 517040 Official trial record

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