RecruitingNot ApplicableNCT06308484

Neuromodulation and Mindfulness Patients With AUD

Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD


Sponsor

Charite University, Berlin, Germany

Enrollment

140 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

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

Exclusion Criteria4

  • 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

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Interventions

DEVICETranscutaneous 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.

DEVICEClosed-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.


Locations(1)

Charité - Berlin University of Medicine

Berlin, State of Berlin, Germany

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NCT06308484


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