Effects of Repetitive tDCS on ad Libitum Smoking Behavior: EMA and EEG Study
Primary Purpose
Addiction
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Addiction focused on measuring Smoking, EMA, ERPs, tDCS, Cigarette consumption, Inhibitory control, Reward processing, Tobacco addiction, Craving, electrophysiological
Eligibility Criteria
Inclusion Criteria:
- Currently smoking 10 or more cigarettes a day
- The ability to speak, read, and write in Dutch at an eight-grade literacy level
Exclusion Criteria:
- The current abuse of a substance other than nicotine or caffeine
- History of neurological or psychiatric disorders
- Any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants
- Pregnancy or breast-feeding
- In the process of quitting smoking
Sites / Locations
- Erasmus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real transcranial Direct Current Stimulation
Sham tDCS
Arm Description
This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for three days in one week.
The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
Outcomes
Primary Outcome Measures
Mean number of cigarettes a day at 3 months follow up
The mean number of cigarettes will be measured at three months follow-up by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this during the week before the last EEG session at three months follow-up.The mean number will be calculated over this week
Secondary Outcome Measures
Mean number of cigarettes a day one week after tDCS
The mean number of cigarettes will be measured at one week after the last tDCS session by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this for one week starting from the last tDCS session. The mean number will be calculated over this week
Craving at 3 months follow-up
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the week before the last EEG session at three months follow-up
Affect 3 months after tDCS
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the week before the last EEG session at three months follow-up
Craving one week after tDCS
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the day after the last tDCS session
Affect one week after tDCS
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the day after the last tDCS session
Behavioral responses of risk-taking
Measured with the two-choice gambling task: proportion of high-risk (higher values) choices
Behavioral responses of inhibitory control
Measured by proportion correctly inhibited NoGo trials on the Go/NoGo task
Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing
Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The Feedback Related Negativity (FRN) will be measured after feedback by means of EEG.
Reward related P300: Event related potential (ERP) of reward processing
Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The reward related P300 will be measured 300-500 ms after feedback by means of EEG.
N200: Event related potential (ERP) of inhibitory control
The N200 will be measured after NoGo trials in the Go/NoGo task
P300: Event related potential (ERP) of inhibitory control
The P300 will be measured after NoGo trials in the Go/NoGo task
Error related negativity: Event related potential (ERP) of error processing
Wrong responses to Go and NoGo trials in the Go/NoGo task will be used to assess the error related negativity (ERN)
Course of cigarette consumption
Number of cigarettes (and craving) a day starting on the first tDCS day until one week after the last tDCS intervention
Full Information
NCT ID
NCT03027687
First Posted
January 5, 2017
Last Updated
November 15, 2018
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03027687
Brief Title
Effects of Repetitive tDCS on ad Libitum Smoking Behavior: EMA and EEG Study
Official Title
Effects of Repetitive tDCS on ad Libitum Smoking Behavior: An EMA and EEG Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time till smoking the first cigarette after the intervention. The current study explores whether actual cigarette consumption decreases after repetitive tDCS. Cigarette consumption and craving will therefore be measured by means of EMA, before (at baseline), during and after multiple tDCS sessions, and at 3 months follow-up.
To study the working mechanism behind the effects of tDCS, electrophysiological responses (ERPs) and behavioral measures of cognitive control functioning will be taken into account at baseline, one day after the last tDCS session and at three months follow up.
We hypothesize that cigarette consumption will decrease after repetitive tDCS, and that this effect is associated with better cognitive control functioning.
Detailed Description
The proposed experiment is a double-blind randomized placebo-controlled trial. 60 smokers will be randomly assigned to two conditions, namely tDCS or sham (placebo).
Participants will receive real tDCS or sham for three days in one week. The interventions contain twice daily sessions for 13 minutes with an interval of 20 min. Moreover, on the first treatment day and the day after the treatment week, participants complete a number of questionnaires, and perform two psychological tasks (a gambling task and the Go/NoGo task) to measure cognitive control functioning (e.g. risky decision making and inhibitory control respectively). During these tasks, event-related potentials will be recorded by means of EEG. After three months, participants are asked to return to fill out the same questionnaires and perform the same psychological tasks as before, to measure the lasting effect of tDCS. During this last session, event-related potentials will also be recorded. In addition, carbon monoxide levels will be measured on all days where subjects perform the tasks.
EMA:
For three weeks, starting the week before tDCS treatment, participants are asked to log every cigarette before they smoke one. During these weeks, participants complete EMA questionnaires on their mobile phone about cigarette consumption, craving, and affect that will take approximately 5 minutes. The EMA questionnaire will be presented four times daily on a quasi-random basis. Finally, during end-of-day assessments participants have the possibility to indicate any missed cigarettes. At three months follow-up, participants are asked to undergo the same EMA procedure for one more week, to study the lasting effects of tDCS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
Smoking, EMA, ERPs, tDCS, Cigarette consumption, Inhibitory control, Reward processing, Tobacco addiction, Craving, electrophysiological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for three days in one week.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
transcranial direct current stimulation
Intervention Description
tDCS is an electrical brain stimulation method
Primary Outcome Measure Information:
Title
Mean number of cigarettes a day at 3 months follow up
Description
The mean number of cigarettes will be measured at three months follow-up by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this during the week before the last EEG session at three months follow-up.The mean number will be calculated over this week
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean number of cigarettes a day one week after tDCS
Description
The mean number of cigarettes will be measured at one week after the last tDCS session by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this for one week starting from the last tDCS session. The mean number will be calculated over this week
Time Frame
1 week
Title
Craving at 3 months follow-up
Description
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the week before the last EEG session at three months follow-up
Time Frame
3 months
Title
Affect 3 months after tDCS
Description
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the week before the last EEG session at three months follow-up
Time Frame
3 months
Title
Craving one week after tDCS
Description
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the day after the last tDCS session
Time Frame
1 week
Title
Affect one week after tDCS
Description
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the day after the last tDCS session
Time Frame
1 week
Title
Behavioral responses of risk-taking
Description
Measured with the two-choice gambling task: proportion of high-risk (higher values) choices
Time Frame
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Title
Behavioral responses of inhibitory control
Description
Measured by proportion correctly inhibited NoGo trials on the Go/NoGo task
Time Frame
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Title
Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing
Description
Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The Feedback Related Negativity (FRN) will be measured after feedback by means of EEG.
Time Frame
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Title
Reward related P300: Event related potential (ERP) of reward processing
Description
Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The reward related P300 will be measured 300-500 ms after feedback by means of EEG.
Time Frame
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Title
N200: Event related potential (ERP) of inhibitory control
Description
The N200 will be measured after NoGo trials in the Go/NoGo task
Time Frame
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Title
P300: Event related potential (ERP) of inhibitory control
Description
The P300 will be measured after NoGo trials in the Go/NoGo task
Time Frame
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Title
Error related negativity: Event related potential (ERP) of error processing
Description
Wrong responses to Go and NoGo trials in the Go/NoGo task will be used to assess the error related negativity (ERN)
Time Frame
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Title
Course of cigarette consumption
Description
Number of cigarettes (and craving) a day starting on the first tDCS day until one week after the last tDCS intervention
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Currently smoking 10 or more cigarettes a day
The ability to speak, read, and write in Dutch at an eight-grade literacy level
Exclusion Criteria:
The current abuse of a substance other than nicotine or caffeine
History of neurological or psychiatric disorders
Any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants
Pregnancy or breast-feeding
In the process of quitting smoking
Facility Information:
Facility Name
Erasmus University
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3000 DR
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32979429
Citation
Verveer I, Remmerswaal D, van der Veen FM, Franken IHA. Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers. Biol Psychol. 2020 Oct;156:107962. doi: 10.1016/j.biopsycho.2020.107962. Epub 2020 Sep 23.
Results Reference
derived
PubMed Identifier
32442205
Citation
Verveer I, Remmerswaal D, Jongerling J, van der Veen FM, Franken IHA. No effect of repetitive tDCS on daily smoking behaviour in light smokers: A placebo controlled EMA study. PLoS One. 2020 May 22;15(5):e0233414. doi: 10.1371/journal.pone.0233414. eCollection 2020.
Results Reference
derived
Learn more about this trial
Effects of Repetitive tDCS on ad Libitum Smoking Behavior: EMA and EEG Study
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