Transcranial Direct Current Stimulation - Tobacco Use Disorder

Study Overview
=================
Brief Summary
-----------------
This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods.

Detailed Description
-----------------
Participating smokers are to receive anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex (rDLPFC) for 20 minutes on five consecutive days. Neuropsychological tests on inhibitory control and interviews on smoking habits and craving will be applied before and after the first stimulation as well as after the fifth stimulation. After a follow-up period of three days, smoking behaviour will be assessed in a telephone interview. Changes in inhibitory control and smoking behaviour will be compared between an active and a sham stimulation group.This way the effects of transcranial direct current stimulation on tobacco use disorder are to be clarified.

Official Title
-----------------
Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Device: tDCS
* Device: Sham tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anodal tDCS over rDLPFC<br>Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC). | Device: tDCS<br>* The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.<br>* Other names: transcranial direct current stimulation;|
| Sham Comparator: sham tDCS<br>Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC. | Device: Sham tDCS<br>* The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Direct Current Stimulation