Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06308484

Neuromodulation and Mindfulness Patients With AUD

Led by Charite University, Berlin, Germany · Updated on 2026-03-20

140

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

M

Medical School Berlin

Collaborating Sponsor

AI-Summary

What this Trial Is About

Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2).

CONDITIONS

Official Title

Neuromodulation and Mindfulness Patients With AUD

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Alcohol Dependence according to ICD-10
  • Abstinent from alcohol for at least 3 days and no more than 12 months
Not Eligible

You will not qualify if you...

  • Current substance use disorder or dependence within the last 12 months other than alcohol
  • Neurological disorders such as epilepsy, neuropathy, or multiple sclerosis
  • Current severe major depressive disorder, manic episode, or schizophreniform disorder
  • Use of anticonvulsive or high-potency antipsychotic medication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Charité - Berlin University of Medicine

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

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Research Team

A

Annika Rosenthal

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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