Neuromodulation and Mindfulness Patients With AUD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCharite University, Berlin, Germany

About this trial

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 criteria

Qualifiers

Alcohol Dependence (ICD-10)

abstinence between 3 days and 12 months

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcutaneous vagus nerve stimulation
  • Closed-loop AM-tACS

Treatment groups

140 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Charite University, Berlin, Germany

Lead sponsor

Health and Medical University Potsdam

Sponsor institution

Medical School Berlin

Collaborator