Neuromodulation and Mindfulness Patients With AUD

NCT06308484 | Recruiting DMC

• 1 other identifier: TRR265 C02 FP2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (3)

• 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).

  Pre and post intervention after 6-8 weeks

• Interoception

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

  Pre and post intervention after 6-8 weeks

• 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.

  Pre and post intervention after 6-8 weeks

Secondary Outcomes (5)

• Heartrate

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

• Heartrate Variability

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

• Mindfulness

  pre, post after 6-8 weeks

• Alcohol consumption

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

• Dependence Severity (Alcohol Dependence Scale)

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

Study Arms (4)

Active transcutaneous vagus nerve stimulation

ACTIVE COMPARATOR

The tVNS device consisted of two titan electrodes mounted on a gel frame and connected to a wired neurostimulation device (tVNS Health GmbH, Germany). Electrodes were placed on the cymba conchae. Stimulation intensity of 0.5 mA, delivered with a pulse width of 200-300 μs at 25 Hz.

Device: Transcutaneous vagus nerve stimulation

Sham transcutaneous vagus nerve stimulation

SHAM COMPARATOR

Stimulation parameters equivalent to active but sham stimulation was administered by positioning the electrodes on the central part of the left earlobe rather than the outer auditory canal, as the earlobe lacks vagus innervation.

Device: Transcutaneous vagus nerve stimulation

Closed-loop AM-tACS increase frontal midline theta oscillation

ACTIVE COMPARATOR

We will deliver amplitude-modulated transcranial alternating current stimulation (AM-tACS) using two circular rubber electrodes (4 cm diameter) positioned at the Fpz and Cz locations of the international 10-20 system. The AM-tACS stimulation waveform features a carrier signal frequency of 10 kHz, an amplitude of ±1 mA, and a signal that is real-time synchronized with theta oscillations of the frontal midline. In the active condition target oscillations (frontal midline theta) will be increased.

Device: Closed-loop AM-tACS

Closed-loop AM-tACS decrease frontal midline theta oscillation

SHAM COMPARATOR

Equivalent to the active comparator - except here the target oscillation will be suppressed.

Device: Closed-loop AM-tACS

Interventions

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.

Closed-loop AM-tACS decrease frontal midline theta oscillation; Closed-loop AM-tACS increase frontal midline theta oscillation

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.

Active transcutaneous vagus nerve stimulation; Sham transcutaneous vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alcohol Dependence (ICD-10)
• abstinence between 3 days and 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical School Berlin: collaborator
• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Berlin University of Medicine

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (4)

• 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 Q, London ED, McClernon J, Noori HR, Owens MM, Paulus MP, Perini I, Potenza M, Potvin S, Ray L, Schacht JP, Seo D, Sinha R, Smolka MN, Spanagel R, Steele VR, Stein EA, Steins-Loeber S, Tapert SF, Verdejo-Garcia A, Vollstadt-Klein S, Wetherill RR, Wilson SJ, Witkiewitz K, Yuan K, Zhang X, Zilverstand A. A methodological checklist for fMRI drug cue reactivity studies: development and expert consensus. Nat Protoc. 2022 Mar;17(3):567-595. doi: 10.1038/s41596-021-00649-4. Epub 2022 Feb 4.

  PMID: 35121856 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anne Beck, Prof. Dr.

  Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany

  PRINCIPAL INVESTIGATOR

• Nina Romanczuk-Seiferth, Prof. Dr.

  Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Surjo Soekadar, Prof. Dr.

  Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Rosenthal

CONTACT

030 450 517040; annika.rosenthal@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Anne Beck

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 13, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)