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

NCT ID: NCT03027687

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-07-31

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.

Conditions

Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real transcranial Direct Current Stimulation

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.

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

tDCS is an electrical brain stimulation method

Sham tDCS

The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: DEVICE

tDCS is an electrical brain stimulation method

Interventions

tDCS

tDCS is an electrical brain stimulation method

Intervention Type: DEVICE

Other Intervention Names

transcranial direct current stimulation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ingmar Franken

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus University

Rotterdam, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 32979429 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32442205 (View on PubMed)

Other Identifiers

NL58190.078.16

Identifier Type: -

Identifier Source: org_study_id