Alcohol DependenceNCT06308484
Neuromodulation and Mindfulness Patients With AUD
A study testing Transcutaneous vagus nerve stimulation and Closed-loop AM-tACS in people with Alcohol Dependence, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Transcutaneous vagus nerve stimulation and Closed-loop AM-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcohol Dependence (ICD-10)
- abstinence between 3 days and 12 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Berlin University of Medicine
Berlin, State of Berlin, 10117
Rosenthal, 0049 30 450 517040
About this study
Official title: Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD
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
- Being tested
- Transcutaneous vagus nerve stimulation, Closed-loop AM-tACS
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulationDevice
Patients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise.
Closed-loop AM-tACSDevice
Patients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Closed-loop AM-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Pre and post intervention after 6-8 weeks
Secondary outcomes (5)
Heartrate
Heartrate change due to stimulation
Measured: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Heartrate Variability
Heartrate variability change due to stimulation
Measured: pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Mindfulness
Trait and state mindfulness
Measured: pre, post after 6-8 weeks
Alcohol consumption
Frequency of drinking days and quantity of alcohol consumed
Measured: pre, post after 6-8 weeks, follow-up three months later
Dependence Severity (Alcohol Dependence Scale)
Craving, urge and dependence severity assessed via questionnaires.
Measured: pre, post after 6-8 weeks, follow-up three months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start20 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Medical School Berlin
- Responsible party
- Principal investigator, Anne Beck, Health and Medical University Potsdam
- Investigators
- Anne Beck, Prof. Dr., Principal investigator, Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, GermanyNina Romanczuk-Seiferth, Prof. Dr., Principal investigator, Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, GermanySurjo Soekadar, Prof. Dr., Principal investigator, Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308484
- Sponsor's protocol ID
- TRR265 C02 FP2
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 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.
PubMed 35121856Swick 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.
PubMed 21376819Kleckner 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.
PubMed 26265009Rosenthal 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.
PubMed 39334026
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD
- ClinicalTrials.gov ID
- NCT06308484
- Acronym / sponsor ID
- TRR265 C02 FP2
- Conditions
- Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Medical School Berlin
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active transcutaneous vagus nerve stimulation | Active comparator | Device: Transcutaneous vagus nerve stimulationThe 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. |
| Sham transcutaneous vagus nerve stimulation | Sham comparator | Device: Transcutaneous vagus nerve stimulationStimulation 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. |
| Closed-loop AM-tACS increase frontal midline theta oscillation | Active comparator | Device: Closed-loop AM-tACSWe 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. |
| Closed-loop AM-tACS decrease frontal midline theta oscillation | Sham comparator | Device: Closed-loop AM-tACSEquivalent to the active comparator - except here the target oscillation will be suppressed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Alcohol Dependence (ICD-10)
- abstinence between 3 days and 12 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagus nerve stimulationPatients that are enrolled in a MBRP program will be subjected to weekly tVNS stimulation during a 30-minute audio guided mindfulness exercise. | Device | Active transcutaneous vagus nerve stimulation, Sham transcutaneous vagus nerve stimulation |
| Closed-loop AM-tACSPatients that are enrolled in a MBRP program will be subjected to weekly CLAM-tACS stimulation during a 30-minute audio guided mindfulness exercise. | Device | Closed-loop AM-tACS decrease frontal midline theta oscillation, Closed-loop AM-tACS increase frontal midline theta oscillation |
Primary outcome
Cognitive Control
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 35121856Ekhtiari 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.
- Background: PubMed 21376819Swick 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.
- Background: PubMed 26265009Kleckner 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.
- Derived from this study: PubMed 39334026Rosenthal 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Beck, Prof. Dr. principal investigator
Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany
Nina Romanczuk-Seiferth, Prof. Dr. principal investigator
Department of Psychology, Clinical Psychology and Psychotherapy, MSB Medical School Berlin, Berlin, Germany
Surjo Soekadar, Prof. Dr. principal investigator
Department of Psychiatry and Psychotherapy, Charité - Berlin University of Medicine, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagus nerve stimulation and Closed-loop AM-tACS in people with Alcohol Dependence, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annika Rosenthal (030 450 517040, annika.rosenthal@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Control (time frame: Pre and post intervention after 6-8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06308484, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.