Neuromodulation and Mindfulness Patients With AUD

Alcohol Dependence Clinical Trial

Official title:

Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308484
• Other study ID #: TRR265 C02 FP2
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2024
• Source: Charite University, Berlin, Germany
• Contact: Annika Rosenthal
• Phone: 030 450 517040
• Email: annika.rosenthal[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charité - Berlin University of Medicine	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Medical School Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Heartrate	Heartrate change due to stimulation	pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Secondary	Heartrate Variability	Heartrate variability change due to stimulation	pre, ad interim at every tVNS and CLAM-tACS stimulation (once per week for 6-8 weeks), post after 6-8 weeks
Secondary	Mindfulness	Trait and state mindfulness	pre, post after 6-8 weeks
Secondary	Alcohol consumption	Frequency of drinking days and quantity of alcohol consumed	pre, post after 6-8 weeks, follow-up three months later
Secondary	Dependence Severity (Alcohol Dependence Scale)	Craving, urge and dependence severity assessed via questionnaires.	pre, post after 6-8 weeks, follow-up three months later

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