Transcranial Direct Current Stimulation - Tobacco Use Disorder

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

August 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduced number of cigarettes smoked[ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Reduced Carving[ Time Frame: 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[ Time Frame: 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.

Descriptive Information

Brief Title ^ICMJE

Transcranial Direct Current Stimulation - Tobacco Use Disorder

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
Masking: Interventional
Masking Description:Participants will be blinded as to their assigned study arm.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Active Comparator: anodal tDCS over rDLPFC
Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC).
Sham Comparator: sham tDCS
Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 2020

Estimated Primary Completion Date

August 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Central Institute of Mental Health, Mannheim

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Sabine Vollstädt-Klein ZI Mannheim

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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