search
Back to results

Effects of Transcranial Direct Current Stimulation on Cigarette Addiction

Primary Purpose

Addiction

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
Transcranial Direct Current Stimulation
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring cigarette smoking, smoking

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • smokers

Exclusion Criteria:

  • use of psychoactive drugs
  • age above 70

Sites / Locations

  • Hospital Universitário de Brasília- HUB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transcranial Direct Current Stimulation

Sham tDCS

Arm Description

These subjects will receive real transcranial direct current stimulation.

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

Outcomes

Primary Outcome Measures

Change in Visual Analogue Scale of Cigarette Craving

Secondary Outcome Measures

Change in Visual Analogue Scale of Motivation to Quit Smoking

Full Information

First Posted
May 13, 2014
Last Updated
May 28, 2016
Sponsor
University of Brasilia
search

1. Study Identification

Unique Protocol Identification Number
NCT02146014
Brief Title
Effects of Transcranial Direct Current Stimulation on Cigarette Addiction
Official Title
Effects of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Cigarette Smoking
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction
Keywords
cigarette smoking, smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
These subjects will receive real transcranial direct current stimulation.
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm Description
These subjects will receive sham transcranial direct current stimulation (placebo)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale of Cigarette Craving
Time Frame
Before and 7 days after treatment
Secondary Outcome Measure Information:
Title
Change in Visual Analogue Scale of Motivation to Quit Smoking
Time Frame
Before and 7 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: smokers Exclusion Criteria: use of psychoactive drugs age above 70
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Boechat-Barros, MD
Organizational Affiliation
University of Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário de Brasília- HUB
City
Brasília
State/Province
DF
ZIP/Postal Code
71910-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29434547
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Transcranial Direct Current Stimulation on Cigarette Addiction

We'll reach out to this number within 24 hrs