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Recruiting NCT06308484

Neuromodulation and Mindfulness Patients With AUD

No phase Interventional Alcohol Dependence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous vagus nerve stimulation, Closed-loop AM-tACS.
Who it may be relevant to
Registry conditions: Alcohol Dependence. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD

Overview

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

  • Device 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.
  • Device 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.

Primary outcome measures

  • Cognitive Control [Time frame: Pre and post intervention after 6-8 weeks]
  • Interoception [Time frame: Pre and post intervention after 6-8 weeks]
  • Cue-Reactivity [Time frame: Pre and post intervention after 6-8 weeks]
Secondary outcome measures (5)
  • Heartrate [Time frame: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks]
  • Heartrate Variability [Time frame: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks]
  • Mindfulness [Time frame: pre, post after 6-8 weeks]
  • Alcohol consumption [Time frame: pre, post after 6-8 weeks, follow-up three months later]
  • Dependence Severity (Alcohol Dependence Scale) [Time frame: pre, post after 6-8 weeks, follow-up three months later]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Germany · 1 center
  • Charité - Berlin University of Medicine — Berlin

Publications

  • Ekhtiari H, Zare-Bidoky M, Sangchooli A, Janes AC, Kaufman MJ, Oliver JA, Prisciandaro JJ, Wustenberg T, Anton RF, Bach P, Baldacchino A, Beck A, Bjork JM, Brewer J, Childress AR, Claus ED, Courtney KE, Ebrahimi M, Filbey FM, Ghahremani DG, Azbari PG, Goldstein RZ, Goudriaan AE, Grodin EN, Hamilton JP, Hanlon CA, Hassani-Abharian P, Heinz A, Joseph JE, Kiefer F, Zonoozi AK, Kober H, Kuplicki R, Li PMID 35121856
  • Swick D, Ashley V, Turken U. Are the neural correlates of stopping and not going identical? Quantitative meta-analysis of two response inhibition tasks. Neuroimage. 2011 Jun 1;56(3):1655-65. doi: 10.1016/j.neuroimage.2011.02.070. Epub 2011 Mar 3. PMID 21376819
  • Kleckner IR, Wormwood JB, Simmons WK, Barrett LF, Quigley KS. Methodological recommendations for a heartbeat detection-based measure of interoceptive sensitivity. Psychophysiology. 2015 Nov;52(11):1432-40. doi: 10.1111/psyp.12503. Epub 2015 Aug 12. PMID 26265009
  • Rosenthal A, Haslacher D, Garbusow M, Pangratz L, Apfel B, Soekadar S, Romanczuk-Seiferth N, Beck A. Neuromodulation and mindfulness as therapeutic treatment in detoxified patients with alcohol use disorder. BMC Psychiatry. 2024 Sep 27;24(1):635. doi: 10.1186/s12888-024-06085-4. PMID 39334026

Identifiers

NCT: NCT06308484 · TRR265 C02 FP2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗