NCT06308484 Neuromodulation and Mindfulness Patients With AUD
| NCT ID | NCT06308484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Alcohol Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-03-20 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Anne Beck, Prof. Dr.
PRINCIPAL INVESTIGATOR
Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany
Frequently Asked Questions
Who can join the NCT06308484 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06308484 currently recruiting?
Yes, NCT06308484 is actively recruiting participants. Contact the research team at annika.rosenthal@charite.de for enrollment information.
Where is the NCT06308484 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT06308484 clinical trial?
NCT06308484 is sponsored by Charite University, Berlin, Germany. The principal investigator is Anne Beck, Prof. Dr. at Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany. The trial plans to enroll 140 participants.