Neuromodulation and Mindfulness Patients With AUD

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcutaneous 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.

Closed-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.

Study 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

Primary outcome measure(s)

• Cognitive Control — 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).
• Interoception — 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).
• Cue-Reactivity — 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.

Trial sites (1)

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