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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02146014
Other study ID # TAB-69168
Secondary ID
Status Completed
Phase N/A
First received May 13, 2014
Last updated May 28, 2016
Start date May 2010
Est. completion date December 2015

Study information

Verified date May 2016
Source University of Brasilia
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- smokers

Exclusion Criteria:

- use of psychoactive drugs

- age above 70

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Placebo
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.
Device:
Transcranial Direct Current Stimulation
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.

Locations

Country Name City State
Brazil Hospital Universitário de Brasília- HUB Brasília DF

Sponsors (1)

Lead Sponsor Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Visual Analogue Scale of Cigarette Craving Before and 7 days after treatment No
Secondary Change in Visual Analogue Scale of Motivation to Quit Smoking Before and 7 days after intervention No
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