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

Study Overview
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Brief Summary
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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.

Detailed Description
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reduction of the rating impulsivity

Official Title
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Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Procedure: Transcranial Magnetic Stimulation
* Procedure: Placebo TMS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994). 20 days or less withdrawal 18-35 years old. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization). Fixed residential address in Sao Paulo Exclusion criteria: Other Mental Disorders (DSM IV, 1994; SCID-P, 1994). organic brain disease, neurosurgery to implant metal clip or epilepsy. severe uncontrolled clinical comorbidity. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day. Changes clinically significant laboratory findings. 13 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. Mandate that mandating the judicial treatment for cocaine dependence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TMS<br>active rTMS delivered to the left dorsolateral prefrontal cortex | Procedure: Transcranial Magnetic Stimulation<br>* ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex<br>* Other names: TMS;|
| Placebo Comparator: Placebo TMS<br>PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex | Procedure: Placebo TMS<br>* PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex<br>* Other names: TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Short PROMIS Questionnaire | The SPQ is a 160-question paper that counsellors and researchers can use to measure an individual's level of addictive tendency in each of sixteen distinct behavioural areas. Will be applied at the following times: T0 (weeks 0 - immediately prior to the rTMS) T1 (4 weeks, after four weeks of treatment with rTMS) and T2 (8 weeks, four weeks after completing treatment). The improvement rate of 10% or more, will be our primary measure of efficacy. T0 ( | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, Cocaine, impulsivity, rating scale