Tobacco Use Disorder Clinical Trial
Official title:
Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving
Verified date | December 2020 |
Source | Central Institute of Mental Health, Mannheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods.
Status | Completed |
Enrollment | 44 |
Est. completion date | February 18, 2020 |
Est. primary completion date | February 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - tobacco use disorder - normal or correctable eyesight - sufficient ability to communicate with the investigators, to answer questions in oral and written form - fully informed consent - written informed consent Exclusion Criteria: - withdrawal of the declaration of consent - exclusion criteria for tDCS (metal implants in the head, acute eczema, known epilepsy) - severe internal, neurological or psychiatric comorbidity - pharmacotherapy with psychoactive substances within the last 14 days - axis-I disorder according to ICD-10 and DSM 5 (except tobacco use disorder) - positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine) - pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Mental Health, Mannheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduced number of cigarettes smoked | Smoking habits will be assessed via interview at the beginning of the study and after a follow-up period of three days. Number of cigarettes smoked will be compared longitudinally and between groups. | First assessment on Day 1, second on Day 8 | |
Secondary | Reduced Carving | Craving will be assessed using visual analog scales on the first and fifth day of the study as well as in the follow-up interview. Ratings will be compared longitudinally and between groups.. | First assessment on Day 1, second on Day 5, third on Day 8 | |
Secondary | Increased inhibitory control | Inhibitory control will be assessed in neuropsychological tests (Go / No-Go, Stop-Signal Task) before and after the first stimulation session and after the fifth session. Results will be compared longitudinally and between groups. | First and second testing on Day 1, third testing on Day 5 |
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