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Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence (TMSCOCAINE)

U

University of Sao Paulo General Hospital

Status and phase

Unknown
Phase 2

Conditions

Cocaine Dependence

Treatments

Procedure: Placebo TMS
Procedure: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01397266
1339/09

Details and patient eligibility

About

In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.

Full description

reduction of the rating impulsivity

Enrollment

20 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
  2. 20 days or less withdrawal
  3. 18-35 years old.
  4. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
  5. Fixed residential address in Sao Paulo

Exclusion criteria

  1. Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
  2. organic brain disease, neurosurgery to implant metal clip or epilepsy.
  3. severe uncontrolled clinical comorbidity.
  4. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
  5. Changes clinically significant laboratory findings. 13
  6. Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.
  7. Mandate that mandating the judicial treatment for cocaine dependence

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Active TMS
Active Comparator group
Description:
active rTMS delivered to the left dorsolateral prefrontal cortex
Treatment:
Procedure: Transcranial Magnetic Stimulation
Placebo TMS
Placebo Comparator group
Description:
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
Treatment:
Procedure: Placebo TMS

Trial contacts and locations

1

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Central trial contact

Ádan Jardim

Data sourced from clinicaltrials.gov

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