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Neuromodulation and Mindfulness Patients With AUD

NCT06308484 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-20

No results posted yet for this study

Summary

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

  • Alcohol Dependence

Interventions

DEVICE

Transcutaneous vagus nerve stimulation

Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise.

DEVICE

Closed-loop AM-tACS

Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.

Sponsors & Collaborators

  • Medical School Berlin

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Anne Beck, Prof. Dr. · Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany

  • Nina Romanczuk-Seiferth, Prof. Dr. · Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany

  • Surjo Soekadar, Prof. Dr. · Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06308484 on ClinicalTrials.gov