Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Direct Current Stimulation - Tobacco Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691805
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Device: tDCS Device: Sham tDCS Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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: Single (Participant)
Masking Description: Participants will be blinded as to their assigned study arm.
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : February 18, 2020
Actual Study Completion Date : February 18, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: anodal tDCS over rDLPFC
Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC).
 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.
Other Names:
  • sooma medical
  • transcranial direct current stimulation
Sham Comparator: sham tDCS
Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691805


Locations
Layout table for location information
Germany
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Germany
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
Layout table for investigator information
Principal Investigator: Sabine Vollstädt-Klein ZI Mannheim
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT03691805    
Other Study ID Numbers: tDCS-TUD
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Institute of Mental Health, Mannheim:
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders