Health TrialsbyHealthPanel

Neuromodulation and Mindfulness Patients With AUD

ConditionAlcohol Dependence
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous vagus nerve stimulation

    Device

    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

    Device

    Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Active transcutaneous vagus nerve stimulationActive comparator 1 intervention
Group B: Sham transcutaneous vagus nerve stimulationSham comparator 1 intervention
Group C: Closed-loop AM-tACS increase frontal midline theta oscillationActive comparator 1 intervention
Group D: Closed-loop AM-tACS decrease frontal midline theta oscillationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive Control

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).

Time frame
Pre and post intervention after 6-8 weeks
2

Interoception

Additionally, interoceptive control is intended to be measured using a heartbeat detection task (Kleckner et al., 2015).

Time frame
Pre and post intervention after 6-8 weeks
3

Cue-Reactivity

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.

Time frame
Pre and post intervention after 6-8 weeks

Secondary outcomes

1

Heartrate

Heartrate change due to stimulation

Time frame
pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
2

Heartrate Variability

Heartrate variability change due to stimulation

Time frame
pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
3

Mindfulness

Trait and state mindfulness

Time frame
pre, post after 6-8 weeks
4

Alcohol consumption

Frequency of drinking days and quantity of alcohol consumed

Time frame
pre, post after 6-8 weeks, follow-up three months later

Other outcomes

Sponsors and contacts

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Charite University, Berlin, Germany

Lead sponsor

Health and Medical University Potsdam

Sponsor institution

Medical School Berlin

Collaborator

Source ClinicalTrials.gov
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