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Transcranial Direct Current Stimulation - Tobacco Use Disorder

Sponsor
Central Institute of Mental Health, Mannheim (Other)
Overall Status
Completed
CT.gov ID
NCT03691805
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
16.1
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: tDCS
  • Device: Sham tDCS
 N/A

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

Study Type:
Interventional
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.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 :
Oct 15, 2018
Actual Primary Completion Date :
Feb 18, 2020
Actual Study Completion Date :
Feb 18, 2020

Arms and Interventions

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

    Primary Outcome Measures

    1. 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

    1. 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..

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit Mannheim Germany

    Sponsors and Collaborators

    • Central Institute of Mental Health, Mannheim

    Investigators

    • Principal Investigator: Sabine Vollstädt-Klein, ZI Mannheim

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Institute of Mental Health, Mannheim
    ClinicalTrials.gov Identifier:
    NCT03691805
    Other Study ID Numbers:
    • tDCS-TUD
    First Posted:
    Oct 2, 2018
    Last Update Posted:
    Dec 30, 2020
    Last Verified:
    Dec 1, 2020
    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:
    Tobacco Use Disorder

    Study Results

    No Results Posted as of Dec 30, 2020