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Bilateral Prefrontal Modulation in Alcoholism

Not Applicable
Completed
Conditions
Drug Addiction
Executive Dysfunction
Registration Number
NCT02091284
Lead Sponsor
Federal University of Espirito Santo
Brief Summary

In this study, eligible alcoholic inpatients recruited from a specialized clinic for addiction 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, 5 x 7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of alcohol 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 craving in alcoholism and this would be a long-lasting effect.

Detailed Description

Before (baseline) and after tDCS or sham-tDCS treatment, subjects were clinically examined regarding craving (obsessive compulsive drinking scale) and they were followed-up for relapses at least 3 months after treatment.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
49
Inclusion Criteria
  • patients between the age of 18 and 60 years;
  • met criteria for alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), as determined by clinical evaluation;
  • in stable clinical condition with no need for inpatient care;
  • able to read, write, and speak Portuguese; and
  • no severe withdrawal signs or symptoms at baseline.
Exclusion Criteria
  • a condition of intoxication or withdrawal due to a substance other alcohol;
  • unstable mental or medical disorder or substance abuse or addiction other than alcohol dependence, except nicotine and/or caffeine;
  • a diagnosis of epilepsy, convulsions, or delirium tremens during abstinence from alcohol;
  • a previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol;
  • any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants;
  • suspected pregnancy for female participants;
  • any contraindication for magnetic resonance procedures such as electronic implants, metal implants, claustrophobia, or permanent make-up or tattoo received within the previous 3 months;
  • the presence of vascular, traumatic, inflammatory, or tumor injuries detectable by CT examination.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
CravingFive applications: first week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fifth week, after the end of the tDCS treatment.

Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Federal University of Espírito Santo

🇧🇷

Vitória, ES - Espírito Santo, Brazil

Federal University of Espírito Santo
🇧🇷Vitória, ES - Espírito Santo, Brazil

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