Transcranial Direct Current Stimulation - Tobacco Use Disorder

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Device: Sham tDCS; Device: tDCS

• Registration Number: NCT03691805
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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.

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Study Start: 2018-10-15
• Primary Completion: 2020-02-18
• Study Completion: 2020-02-18
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS	Sham tDCS	Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC.
anodal tDCS over rDLPFC	tDCS	Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC).

Primary Outcome Measures

Name	Time	Method
Reduced number of cigarettes smoked	First assessment on Day 1, second on Day 8	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.

Secondary Outcome Measures

Name	Time	Method
Reduced Carving	First assessment on Day 1, second on Day 5, third on Day 8	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..
Increased inhibitory control	First and second testing on Day 1, third testing on Day 5	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.

Trial Locations

Locations (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit; 🇩🇪 Mannheim, Germany