Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients

NCT ID: NCT01259362

Last Updated: 2010-12-22

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-07-31

Brief Summary

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Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing craving and extending the abstinence period of this patients during treatment.

The aim of this study is to evaluate reduction if craving and other parameters related to addiction within this group of patients through a treatment with transcranial magnetic stimulation.

Detailed Description

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Patients are going to submitted do a course of rTMS of one month, each session up to 15 minutes.

After the rTMS they are going to be offered cognitive therapy to prevent relapse.

The area stimulated is the dorso-lateral prefrontal cortex. This technique was employed in previous studies and the risks are insignificant.

Conditions

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Cocaine Addiction Treatment Transcranial Magnetic Stimilation

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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Transcranial Magnetic Stimulation

Cocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.

Transcranial Magnetic Stimlation

cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

Cocaine addicted will receive 20 sham TMSr

Interventions

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Transcranial Magnetic Stimulation

5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.

Intervention Type PROCEDURE

Transcranial Magnetic Stimulation

Cocaine addicted will receive 20 sham TMSr

Intervention Type PROCEDURE

Other Intervention Names

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rTMS Cocaine Addiction Cocaine Addiction Treatment TMS Cocaine Addiction Sham Stimulation

Eligibility Criteria

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Inclusion Criteria

* Minimum age of 18
* Maximum age of 40
* Diagnostic of Cocaine addiction
* Willingly participate the study

Exclusion Criteria

* Metallic Cerebral Implant
* History of Severe Brain trauma or injury
* Organic Brain Disease
* Severe Somatic Disease
* History of other actual or past psychiatric diagnostics
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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Department and Institute of Psychiatry, General Hospital University of Sao Paulo

Principal Investigators

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Philip L Ribeiro, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP

Locations

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Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Philip L Ribeiro, MD

Role: CONTACT

Phone: 551130698159

Email: [email protected]

Facility Contacts

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Philip L Ribeiro, md

Role: primary

Other Identifiers

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PLRIBEIRO1

Identifier Type: -

Identifier Source: org_study_id