N/A N=49 Randomized Triple-blind Treatment

Bilateral Prefrontal Modulation in Alcoholism

Drug Addiction · Executive Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT02091284 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Craving — 5.522; 3.818; 4.391; 4.136 scores — p=< 0.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: transcranial Direct Current Stimulation (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Federal University of Espirito Santo
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Craving	5.522; 3.818; 4.391; 4.136; 3.348; 3.545	< 0.01 sig

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02091284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.