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Transcranial Direct Current Stimulation - Tobacco Use Disorder

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
Sham tDCS
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

anodal tDCS over rDLPFC

sham tDCS

Arm Description

Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC).

Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC.

Outcomes

Primary Outcome Measures

Reduced number of cigarettes smoked
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

Reduced Carving
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
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.

Full Information

First Posted
September 28, 2018
Last Updated
December 29, 2020
Sponsor
Central Institute of Mental Health, Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT03691805
Brief Title
Transcranial Direct Current Stimulation - Tobacco Use Disorder
Official Title
Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
February 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
Masking
Participant
Masking Description
Participants will be blinded as to their assigned study arm.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS over rDLPFC
Arm Type
Active Comparator
Arm Description
Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC).
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
sooma medical, transcranial direct current stimulation
Intervention Description
The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
Primary Outcome Measure Information:
Title
Reduced number of cigarettes smoked
Description
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.
Time Frame
First assessment on Day 1, second on Day 8
Secondary Outcome Measure Information:
Title
Reduced Carving
Description
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..
Time Frame
First assessment on Day 1, second on Day 5, third on Day 8
Title
Increased inhibitory control
Description
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.
Time Frame
First and second testing on Day 1, third testing on Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Vollstädt-Klein
Organizational Affiliation
ZI Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
City
Mannheim
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34198135
Citation
Muller T, Shevchenko Y, Gerhardt S, Kiefer F, Vollstadt-Klein S. The influence of perceived stress and self-control on efficacy of repeated transcranial direct current stimulation in non-treatment-seeking smokers. Drug Alcohol Depend. 2021 Sep 1;226:108861. doi: 10.1016/j.drugalcdep.2021.108861. Epub 2021 Jun 24.
Results Reference
derived

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Transcranial Direct Current Stimulation - Tobacco Use Disorder

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