Bilateral Prefrontal Modulation in Crack-cocaine Addiction
Condition: Drug Addiction; Executive Dysfunction
MeSH terms: Substance-Related Disorders; Behavior, Addictive
Intervention: transcranial Direct Current Stimulation
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sham-controlled double-blind randomized clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: crack-cocaine addiction; tDCS; dlPFC; craving; cognition

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.
    

Eligibility criteria:

        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;