Transcranial Direct Current Stimulation - Tobacco Use Disorder

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691805
• Other study ID #: tDCS-TUD
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: February 18, 2020

Study information

• Verified date: December 2020
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Device:
• tDCS
The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
• Sham tDCS
The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.

Locations

Country	Name	City	State
Germany	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

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