Neuromodulation and Mindfulness Patients With AUD

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Alcohol Dependence

In brief

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).

Key facts

Study ID

NCT06308484

Run by

Charite University, Berlin, Germany

People needed

140

Starts

2024-03-20

Expected to finish

2027-06-30

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Charité - Berlin University of Medicine — Berlin, State of Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.