NCT02146014

Brief Summary

Tobacco addiction is treatable with behavioral and pharmacological means, but results are often less than optimal. Transcranial direct current stimulation is a new non-invasive technique that applies weak electrical currents through the skull and has been shown to alter the excitability of certain brain areas. It is currently being tried in disorders where there is abnormal brain excitability, such as epilepsy and depression. A few studies have also been able to diminish drug craving, suggesting that brain excitability might also be altered in drug addiction. This study aims at non-invasively changing the excitability of certain brain areas-a procedure called neuromodulation- in order to help smokers quit smoking more easily.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

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

May 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

5.6 years

First QC Date

May 13, 2014

Last Update Submit

May 28, 2016

Conditions

Keywords

cigarette smoking, smoking

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analogue Scale of Cigarette Craving

    Before and 7 days after treatment

Secondary Outcomes (1)

  • Change in Visual Analogue Scale of Motivation to Quit Smoking

    Before and 7 days after intervention

Study Arms (2)

Transcranial Direct Current Stimulation

EXPERIMENTAL

These subjects will receive real transcranial direct current stimulation.

Device: Transcranial Direct Current Stimulation

Sham tDCS

PLACEBO COMPARATOR

These subjects will receive sham transcranial direct current stimulation (placebo)

Other: Placebo

Interventions

PlaceboOTHER

Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions. In the placebo group the current will be off.

Sham tDCS

Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions.

Transcranial Direct Current Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smokers

You may not qualify if:

  • use of psychoactive drugs
  • age above 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário de Brasília- HUB

Brasília, Federal District, 71910-900, Brazil

Location

Related Publications (1)

  • Vitor de Souza Brangioni MC, Pereira DA, Thibaut A, Fregni F, Brasil-Neto JP, Boechat-Barros R. Effects of Prefrontal Transcranial Direct Current Stimulation and Motivation to Quit in Tobacco Smokers: A Randomized, Sham Controlled, Double-Blind Trial. Front Pharmacol. 2018 Jan 26;9:14. doi: 10.3389/fphar.2018.00014. eCollection 2018.

MeSH Terms

Conditions

Behavior, AddictiveCigarette Smoking

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorTobacco SmokingSmokingTobacco Use

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Raphael Boechat-Barros, MD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

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
Dr.

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 23, 2014

Study Start

May 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations