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Completed

NCT Number: NCT02091167

Bilateral Prefrontal Modulation in Crack-cocaine Addiction

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.

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Key information

Conditions

Drug Addiction Chemically-Induced Disorders Executive Dysfunction Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Espírito Santo

Vitória, ES - Espírito Santo, 29060-720, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients between the age of 18 and 60 years;
  • met criteria for crack-cocaine dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), 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 than crack-cocaine;
  • unstable mental or medical disorder or substance abuse or addiction other than crack-cocaine dependence, except nicotine and/or caffeine;
  • a diagnosis of epilepsy, convulsions;
  • 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;

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Direct 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.

Other names: tDCS

Primary outcomes

  1. Craving

    Time frame: Five applications: once in the week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fith 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.

  2. Relapses

    Time frame: 30 and 60 days after discharge from clinics

    A use relapse was defined as the first episode of return to the previous uncontrolled pattern of crack-cocaine use (rocks per day). Information about relapse were gathered directly when patients regularly returned to the hospital for clinical follow-up after their discharge and/or by self-report or reports of family members by telephone calls.

Sponsors and collaborators

Lead sponsor

Federal University of Espirito Santo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Harvard Medical School (HMS and HSDM)
  • University of Göttingen

Registry information

Official study title

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

Acronym: tDCS_CRACK

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2014
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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