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Neuromodulation and Mindfulness Patients With AUD

StatusRecruiting
PhaseNot applicable
Started2024-03-20
View on ClinicalTrials.gov ↗

Amendment history

2026-03-18
minor
Study Status, Contacts/Locations v2
Study sitesdetails revised at 1 of 1 site
2024-08-19
minor
Study Status v1
Re-verified, no change to tracked fields
2024-03-06
minor
Original filing
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).
Trial Details
NCT Number NCT06308484
Lead Sponsor Charite University, Berlin, Germany
Collaborators: Medical School Berlin
Conditions Alcohol Dependence
Enrollment 140 participants
Start Date 2024-03-20
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-20