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Clinical Trials in Germany / NCT06959342
Recruiting Not applicable

Modification of Inhibitory Control and Craving Through Transcranial Direct Current Stimulation (tDCS) as an Add-On Treatment for Substance Use Disorder

NCT06959342 · tracked via the Priya Life Science Germany tracker
Sponsor
Central Institute of Mental Health, Mannheim
Phase
Not applicable
Started
2024-09-23
Last updated
2025-06-04

Condition(s) studied

Alcohol Use DisorderSubstance Use Disorders

Investigational drug(s) / intervention(s)

Transcranial direct current stimulation (tDCS)Inhibition Training

Transcranial direct current stimulation (tDCS): tDCS sessions on five consecutive days for 20 minutes.

Inhibition Training: Computerized Training of inhibitory control (Go-/No-Go task with pictures of preferred alcohol) on five consecutive days.

Study summary

The aim of this project is to investigate the potential of transcranial direct current stimulation (tDCS) to reduce cognitive deficits and substance craving in individuals with substance use disorders (SUD), with a focus on alcohol use disorder (AUD). Patients of any gender between the ages of 18 and 65 are examined who are in our inpatient and day clinic settings for a standard detoxification treatment program. As there are conflicting findings regarding the effective settings for tDCS as an adjunctive treatment in SUD (e.g., effects on inhibitory control seem to be sensitive to current direction), the aim is to examine and compare three different active tDCS conditions, a sham tDCS condition (placebo), inhibition training, and a control group of patients receiving only standard detoxification treatment. The aim is to identify the optimal electrode placement and current direction to positively influence both inhibitory control and craving, leading to improved treatment outcomes such as longer abstinence periods or reduced substance use after relapse.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * main diagnosis: alcohol use disorder according to DSM-5 * patients of any gender aged 18 to 65 * normal vision or correctable visual impairment. * sufficient ability to communicate verbally and in writing * ability to give fully informed consent after reviewing thorough written information Exclusion Criteria: * withdrawal of consent * severe internal, neurological, or psychiatric comorbidities (e.g., lifetime schizophrenia, bipolar disorder, or other severe mental disorders according to ICD-10 and DSM-5, such as severe depression or PTSD within the last 12 months). * Exclusion criteria for an EEG/tDCS examination (e.g. metal implants in the head, epilepsy, etc.) * severe withdrawal symptoms (CIWA-R \> 7) * alcohol intoxication (breath alcohol concentration \> 0 ‰) * Pharmacotherapy with psychoactive substances within the last 14 days (exceptions: clomethiazole or benzodiazepines used in withdrawal treatment, provided they were discontinued at least 3 days prior; antidepressants or anxiolytics taken at stable doses). * drug or alcohol use within the last 7 days * for women: pregnancy * suicidal tendencies or danger to others

Primary outcome measure(s)

  • Inhibitory Control (Go/No-Go Task) — intervention day 1 (T1), intervention day 5 (T5), follow-up after 12 weeks (T8)
    Change in performance in a modified Go/No-Go task. Measures inhibitory control under varying working memory loads.
  • Inhibitory Control (EEG) — intervention day 1 (T1), intervention day 5 (T5), follow-up after 12 weeks (T8)
    Change in event-related potentials (ERPs), specifically the P300 and N200 components, measured by EEG during Go-/NO-GO task (32 channels with active electrodes, mBrainTrain, Belgrade, Serbia); sampling rate 1000Hz, filtered between 0.016-1000Hz, programmed in Presentation® software (Neurobehavioral Systems, Inc., Berkeley, CA, USA).
  • Craving — intervention day 1 and 5 (T1, T5), follow-up after 4 weeks (T6), follow-up after 8 weeks (T7), follow-up after 12 weeks (T8), follow-up after 24 weeks (T9)
    Change in subjective craving according to Alcohol Urge Questionnaire and craving scale. Alcohol Urge Questionnaire: 7-item Likert scale ranging from "strongly disagree" to "strongly agree"). A total score is calculated by averaging the scores for each item. Higher scores indicate stronger craving. Craving scale: Craving from 0-100%. Higher scores indicate stronger cravings.

Trial sites (2)

FacilityCityRegionStatus
Central Institute of Mental Health Mannheim Germany Recruiting
Psychiatrisches Zentrum Nordbaden (Psychiatric Center Nordbaden) Wiesloch Germany Not Yet Recruiting

More Central Institute of Mental Health, Mannheim trials in Germany

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Enhancing Recovery in Early Schizophrenia Active, not recruiting
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Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption Recruiting

Other trials for the same condition

Prevention of Mental Disorders Through Self-efficacy Interventions Recruiting
Validation of a Training Program for Patients With Alcohol Use Disorder Active, not recruiting
Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder Starting soon
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder Recruiting
A Study of Brenipatide in Participants With Alcohol Use Disorder Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06959342 on ClinicalTrials.gov ↗ ← All trials in Germany