Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06308484

Neuromodulation and Mindfulness 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Berlin University of Medicine

Berlin, State of Berlin, 10117, Germany

Location status: Recruiting

Location contact

Rosenthal

CONTACT

0049 30 450 517040

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous vagus nerve stimulation

Device

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

Closed-loop AM-tACS

Device

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Mindfulness

    Time frame: pre, post after 6-8 weeks

    Trait and state mindfulness

  4. Alcohol consumption

    Time frame: pre, post after 6-8 weeks, follow-up three months later

    Frequency of drinking days and quantity of alcohol consumed

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annika Rosenthal

CONTACT

[email protected]

030 450 517040

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Medical School Berlin

Registry information

Official study title

Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.