Neuromodulation and Mindfulness Patients With AUD

March 18, 2026 updated by: Anne Beck, Charite University, Berlin, Germany

Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • Recruiting
        • Charité - Berlin University of Medicine
        • Contact:
          • Rosenthal
          • Phone Number: 0049 30 450 517040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Alcohol Dependence (ICD-10)
  • abstinence between 3 days and 12 months

Exclusion Criteria:

  • current (last 12 months) substance use disorder/dependence
  • neurological disorders (e.g. epilepsy, neuropathy, multiple sclerosis)
  • current severe major depressive disorder, manic episode or schizophreniform disorder
  • intake of anticonvulsive or high-potency antipsychotic medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active transcutaneous vagus nerve stimulation
The tVNS device consisted of two titan electrodes mounted on a gel frame and connected to a wired neurostimulation device (tVNS Health GmbH, Germany). Electrodes were placed on the cymba conchae. Stimulation intensity of 0.5 mA, delivered with a pulse width of 200-300 μs at 25 Hz.
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.
Sham Comparator: Sham transcutaneous vagus nerve stimulation
Stimulation parameters equivalent to active but sham stimulation was administered by positioning the electrodes on the central part of the left earlobe rather than the outer auditory canal, as the earlobe lacks vagus innervation.
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.
Active Comparator: Closed-loop AM-tACS increase frontal midline theta oscillation
We will deliver amplitude-modulated transcranial alternating current stimulation (AM-tACS) using two circular rubber electrodes (4 cm diameter) positioned at the Fpz and Cz locations of the international 10-20 system. The AM-tACS stimulation waveform features a carrier signal frequency of 10 kHz, an amplitude of ±1 mA, and a signal that is real-time synchronized with theta oscillations of the frontal midline. In the active condition target oscillations (frontal midline theta) will be increased.
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.
Sham Comparator: Closed-loop AM-tACS decrease frontal midline theta oscillation
Equivalent to the active comparator - except here the target oscillation will be suppressed.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive Control
Time Frame: Pre and post intervention after 6-8 weeks
Before and after the treatment, we will assess cognitive control on a behavioral (response inhibition) and neurophysiological level (electroencephalogram) using a Simon GoNogo task, which reliably triggers activation of the frontal midline regions (Swick et al., 2011).
Pre and post intervention after 6-8 weeks
Interoception
Time Frame: Pre and post intervention after 6-8 weeks
Additionally, interoceptive control is intended to be measured using a heartbeat detection task (Kleckner et al., 2015).
Pre and post intervention after 6-8 weeks
Cue-Reactivity
Time Frame: Pre and post intervention after 6-8 weeks
Evaluate physiological reactivity to alcohol cues through a passive viewing task developed based on the guidelines of Ekhitiari et al. (2022) and measure subjective cue-induced cravings.
Pre and post intervention after 6-8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heartrate
Time Frame: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Heartrate change due to stimulation
pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Heartrate Variability
Time Frame: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Heartrate variability change due to stimulation
pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Mindfulness
Time Frame: pre, post after 6-8 weeks
Trait and state mindfulness
pre, post after 6-8 weeks
Alcohol consumption
Time Frame: pre, post after 6-8 weeks, follow-up three months later
Frequency of drinking days and quantity of alcohol consumed
pre, post after 6-8 weeks, follow-up three months later
Dependence Severity (Alcohol Dependence Scale)
Time Frame: pre, post after 6-8 weeks, follow-up three months later
Craving, urge and dependence severity assessed via questionnaires.
pre, post after 6-8 weeks, follow-up three months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical School Berlin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Beck, Prof. Dr., Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany
  • Principal Investigator: Nina Romanczuk-Seiferth, Prof. Dr., Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany
  • Principal Investigator: Surjo Soekadar, Prof. Dr., Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRR265 C02 FP2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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