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

NCT ID: NCT01397266

Last Updated: 2011-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-07-31

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

Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active TMS

active rTMS delivered to the left dorsolateral prefrontal cortex

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex

Placebo TMS

PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Group Type PLACEBO_COMPARATOR

Placebo TMS

Intervention Type PROCEDURE

PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Interventions

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Transcranial Magnetic Stimulation

ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex

Intervention Type PROCEDURE

Placebo TMS

PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Intervention Type PROCEDURE

Other Intervention Names

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TMS TMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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USaoPauloGH

Principal Investigators

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Adan Jardim

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Ádan Jardim

Role: CONTACT

+551130698159

Facility Contacts

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Ádan P JArdim

Role: primary

55 11 30698159

Other Identifiers

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1339/09

Identifier Type: -

Identifier Source: org_study_id

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