Clinical trial NCT06308484: Neuromodulation and Mindfulness Patients With AUD
Official title: Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Dependence
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Medical School Berlin
First posted: 2024-03-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Primary outcomes:
measure: Cognitive Control
timeFrame: Pre and post intervention after 6-8 weeks
measure: Interoception
timeFrame: Pre and post intervention after 6-8 weeks
measure: Cue-Reactivity
timeFrame: Pre and post intervention after 6-8 weeks
Secondary outcomes:
measure: Heartrate
timeFrame: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
measure: Heartrate Variability
timeFrame: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
measure: Mindfulness
timeFrame: pre, post after 6-8 weeks
measure: Alcohol consumption
timeFrame: pre, post after 6-8 weeks, follow-up three months later
measure: Dependence Severity (Alcohol Dependence Scale)
timeFrame: pre, post after 6-8 weeks, follow-up three months later
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Berlin University of Medicine
Study officials:
affiliation: Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany
name: Anne Beck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany
name: Nina Romanczuk-Seiferth, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany
name: Surjo Soekadar, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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citation: 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.