Bilateral Prefrontal Modulation in Crack-cocaine Addiction (tDCS_CRACK)

Federal University of Espirito Santo

Status and phase: Completed; Phase 2

Conditions: Executive Dysfunction; Drug Addiction

Treatments: Device: transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02091167

tDCS CRACK CEP_UFES 384281

CNPq_ 475232/2013-5 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups

real tDCS

Experimental group

Description:

Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).

Treatment:

Device: transcranial Direct Current Stimulation

sham-tDCS

Sham Comparator group

Description:

Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.

Treatment:

Device: transcranial Direct Current Stimulation