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Completed

NCT Number: NCT03691805

Transcranial Direct Current Stimulation - Tobacco Use Disorder

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

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

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

Other names: sooma medical, transcranial direct current stimulation

Sham tDCS

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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..

  2. 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.

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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