- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02146014
Effects of Transcranial Direct Current Stimulation on Cigarette Addiction
Effects of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Cigarette Smoking
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DF
-
Brasília, DF, Brazil, 71910-900
- Hospital Universitário de Brasília- HUB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- smokers
Exclusion Criteria:
- use of psychoactive drugs
- age above 70
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transcranial Direct Current Stimulation
These subjects will receive real 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.
|
|
Placebo Comparator: Sham tDCS
These subjects will receive sham transcranial direct current stimulation (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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Visual Analogue Scale of Cigarette Craving
Time Frame: Before and 7 days after treatment
|
Before and 7 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Visual Analogue Scale of Motivation to Quit Smoking
Time Frame: Before and 7 days after intervention
|
Before and 7 days after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raphael Boechat-Barros, MD, University of Brasilia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAB-69168
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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