Status:
RECRUITING
Modification of Inhibitory Control and Craving Through Transcranial Direct Current Stimulation (tDCS) as an Add-On Treatment for Substance Use Disorder
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Collaborating Sponsors:
Wellcome Leap Inc.
Conditions:
Alcohol Use Disorder
Substance Use Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
The aim of this study is to determine the optimal electrode placement and current direction of tDCS as an adjunctive therapy for SUD to improve both inhibitory control and craving, ultimately contribu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06959342
Start Date
September 23 2024
End Date
September 30 2027
Last Update
June 4 2025
Active Locations (2)
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1
Central Institute of Mental Health
Mannheim, Germany, 68159
2
Psychiatrisches Zentrum Nordbaden (Psychiatric Center Nordbaden)
Wiesloch, Germany, 69168