Clinical trial NCT03027687: 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
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Keywords: Smoking
EMA
ERPs
tDCS
Cigarette consumption
Inhibitory control
Reward processing
Tobacco addiction
Craving
electrophysiological
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean number of cigarettes a day at 3 months follow up
timeFrame: 3 months
Secondary outcomes:
measure: Mean number of cigarettes a day one week after tDCS
timeFrame: 1 week
measure: Craving at 3 months follow-up
timeFrame: 3 months
measure: Affect 3 months after tDCS
timeFrame: 3 months
measure: Craving one week after tDCS
timeFrame: 1 week
measure: Affect one week after tDCS
timeFrame: 1 week
measure: Behavioral responses of risk-taking
timeFrame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
measure: Behavioral responses of inhibitory control
timeFrame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
measure: Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing
timeFrame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
measure: Reward related P300: Event related potential (ERP) of reward processing
timeFrame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
measure: N200: Event related potential (ERP) of inhibitory control
timeFrame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
measure: P300: Event related potential (ERP) of inhibitory control
timeFrame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
measure: Error related negativity: Event related potential (ERP) of error processing
timeFrame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
measure: Course of cigarette consumption
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University
state: Zuid-Holland
Study officials:
References:
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.
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.