AzTrials
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AddictionNCT03027687

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

A study testing tDCS in people with Addiction, run by Erasmus Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Addiction
What is being tested?
tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
1 siteNetherlands
Study dates
Oct 2016to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Currently smoking 10 or more cigarettes a day
  • The ability to speak, read, and write in Dutch at an eight-grade literacy level

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Erasmus University

    Rotterdam, South Holland, 3000 DR

Other trials in Netherlands

About this study

Official title: Effects of Repetitive tDCS on ad Libitum Smoking Behavior: An 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.

Read the 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.

Conditions
Addiction
Being tested
tDCS
Keywords
Smoking, EMA, ERPs, tDCS, Cigarette consumption, Inhibitory control, Reward processing, Tobacco addiction, Craving, electrophysiological
Medical subject headings
Behavior, Addictive, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    Also called transcranial direct current stimulation

    tDCS is an electrical brain stimulation method

Study groups in NCT03027687
Study groupRoleWhat they receive
Real transcranial Direct Current StimulationExperimentalThis 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.
Receives: Device: tDCS
Sham tDCSSham comparatorThe control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months

Secondary outcomes (13)

  1. 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

    Measured: 1 week

  2. 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

    Measured: 3 months

  3. 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

    Measured: 3 months

  4. 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

    Measured: 1 week

  5. 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

    Measured: 1 week

  6. Behavioral responses of risk-taking

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

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

  7. Behavioral responses of inhibitory control

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

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

  8. 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.

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

  9. 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.

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

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

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

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

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

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

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

  12. 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)

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

  13. 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

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionMar 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03027687
Sponsor's protocol ID
NL58190.078.16
Status last verified
Nov 2018
First submitted
5 Jan 2017
Last updated
16 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32979429

  • 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.

    PubMed 32442205

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Addiction, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean number of cigarettes a day at 3 months follow up (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03027687, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.

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