NCT03027687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

January 5, 2017

Last Update Submit

November 15, 2018

Conditions

Addiction

Keywords

SmokingEMAERPstDCSCigarette consumptionInhibitory controlReward processingTobacco addictionCravingelectrophysiological

Outcome Measures

Primary Outcomes (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

    3 months

Secondary Outcomes (13)

  • Mean number of cigarettes a day one week after tDCS

    1 week

  • Craving at 3 months follow-up

    3 months

  • Affect 3 months after tDCS

    3 months

  • Craving one week after tDCS

    1 week

  • Affect one week after tDCS

    1 week

  • +8 more secondary outcomes

Study Arms (2)

Real transcranial Direct Current Stimulation

EXPERIMENTAL

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.

Device: tDCS

Sham tDCS

SHAM COMPARATOR

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

Device: tDCS

Interventions

tDCSDEVICE

tDCS is an electrical brain stimulation method

Also known as: transcranial direct current stimulation
Real transcranial Direct Current StimulationSham tDCS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus University

Rotterdam, South Holland, 3000 DR, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 32979429DERIVED

  • 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.

    PMID: 32442205DERIVED

MeSH Terms

Conditions

Behavior, AddictiveSmoking

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 23, 2017

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)