Alcohol Dependence
Conditions
Brief 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).
Interventions
DEVICETranscutaneous 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.
DEVICEClosed-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.
Sponsors
Charite University, Berlin, Germany
Medical School Berlin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Alcohol Dependence (ICD-10) * abstinence between 3 days and 12 months
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heartrate | pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks | Heartrate change due to stimulation |
| Heartrate Variability | pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks | Heartrate variability change due to stimulation |
| Mindfulness | pre, post after 6-8 weeks | Trait and state mindfulness |
| Alcohol consumption | pre, post after 6-8 weeks, follow-up three months later | Frequency of drinking days and quantity of alcohol consumed |
| Dependence Severity (Alcohol Dependence Scale) | pre, post after 6-8 weeks, follow-up three months later | Craving, urge and dependence severity assessed via questionnaires. |
Countries
Germany
Contacts
CONTACTAnnika Rosenthal
PRINCIPAL_INVESTIGATORAnne Beck, Prof. Dr.
Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany
PRINCIPAL_INVESTIGATORNina Romanczuk-Seiferth, Prof. Dr.
Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany
PRINCIPAL_INVESTIGATORSurjo Soekadar, Prof. Dr.
Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany
Outcome results
None listed