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

Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027687
• Other study ID #: NL58190.078.16
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: November 2018
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Intervention

Device:
• tDCS
tDCS is an electrical brain stimulation method

Locations

Country	Name	City	State
Netherlands	Erasmus University	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	1 week
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	1 week
Secondary	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	1 week
Secondary	Behavioral responses of risk-taking	Measured with the two-choice gambling task: proportion of high-risk (higher values) choices	3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Secondary	Behavioral responses of inhibitory control	Measured by proportion correctly inhibited NoGo trials on the Go/NoGo task	3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Secondary	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.	3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Secondary	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.	3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Secondary	N200: Event related potential (ERP) of inhibitory control	The N200 will be measured after NoGo trials in the Go/NoGo task	3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Secondary	P300: Event related potential (ERP) of inhibitory control	The P300 will be measured after NoGo trials in the Go/NoGo task	3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Secondary	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)	3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Secondary	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	2 weeks