Clinical Trials Directory

Trials / Completed

CompletedNCT02091167

Bilateral Prefrontal Modulation in Crack-cocaine Addiction

Prefrontal Modulation by Repetitive Bilateral Transcranial Direct Current Stimulation (tDCS) in Crack-cocaine Addicted Inpatients.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Federal University of Espirito Santo · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

In this study, eligible crack-cocaine addicted inpatients recruited from specialized clinics for substance abuse disorder treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 3x7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of crack-cocaine was examined before (baseline), during and after the end of the tDCS treatment. Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change clinical, cognitive and brain function in crack-cocaine addiction and these would be long-lasting effects.

Detailed description

Before (baseline) and after tDCS or sham-tDCS treatment, subjects were examined: (1) clinically, regarding craving (obsessive compulsive scale) and relapses to the drug use. They were followed-up for clinical examination at least 60 days after treatment.

Conditions

Interventions

TypeNameDescription
DEVICEtranscranial Direct Current StimulationDirect currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.

Timeline

Start date
2013-11-01
Primary completion
2018-07-01
Completion
2018-07-01
First posted
2014-03-19
Last updated
2019-06-24
Results posted
2019-06-24

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT02091167. Inclusion in this directory is not an endorsement.