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Completed

NCT Number: NCT03027687

Effects of Repetitive tDCS on ad Libitum Smoking Behavior: EMA and EEG Study

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.

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Key information

Conditions

Addiction Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior Smoking

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus University

Rotterdam, South Holland, 3000 DR, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

tDCS

Device

tDCS is an electrical brain stimulation method

Other names: transcranial direct current stimulation

Primary outcomes

  1. Mean number of cigarettes a day at 3 months follow up

    Time frame: 3 months

    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 outcomes

  1. Mean number of cigarettes a day one week after tDCS

    Time frame: 1 week

    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

  2. Craving at 3 months follow-up

    Time frame: 3 months

    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

  3. Affect 3 months after tDCS

    Time frame: 3 months

    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

  4. Craving one week after tDCS

    Time frame: 1 week

    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

  5. Affect one week after tDCS

    Time frame: 1 week

    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

  6. Behavioral responses of risk-taking

    Time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up

    Measured with the two-choice gambling task: proportion of high-risk (higher values) choices

  7. Behavioral responses of inhibitory control

    Time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up

    Measured by proportion correctly inhibited NoGo trials on the Go/NoGo task

  8. Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing

    Time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up

    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.

  9. Reward related P300: Event related potential (ERP) of reward processing

    Time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up

    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.

  10. N200: Event related potential (ERP) of inhibitory control

    Time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up

    The N200 will be measured after NoGo trials in the Go/NoGo task

  11. P300: Event related potential (ERP) of inhibitory control

    Time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up

    The P300 will be measured after NoGo trials in the Go/NoGo task

  12. Error related negativity: Event related potential (ERP) of error processing

    Time frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up

    Wrong responses to Go and NoGo trials in the Go/NoGo task will be used to assess the error related negativity (ERN)

  13. Course of cigarette consumption

    Time frame: 2 weeks

    Number of cigarettes (and craving) a day starting on the first tDCS day until one week after the last tDCS intervention

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Effects of Repetitive tDCS on ad Libitum Smoking Behavior: An EMA and EEG Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2017
Registry last updated
Nov 16, 2018

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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