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

December 21, 2010 updated by: University of Sao Paulo General Hospital

Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403010
        • Recruiting
        • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
        • Contact:
        • Sub-Investigator:
          • Philip L Ribeiro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcranial Magnetic Stimulation
Cocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.
Procedure: Transcranial Magnetic Stimulation
5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
Other Names:
  • rTMS
  • Cocaine Addiction
  • Cocaine Addiction Treatment
Procedure: Transcranial Magnetic Stimulation
Cocaine addicted will receive 20 sham TMSr
Other Names:
  • TMS
  • Sham Stimulation
  • Cocaine Addiction
Sham Comparator: Transcranial Magnetic Stimlation
cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex
Procedure: Transcranial Magnetic Stimulation
5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
Other Names:
  • rTMS
  • Cocaine Addiction
  • Cocaine Addiction Treatment
Procedure: Transcranial Magnetic Stimulation
Cocaine addicted will receive 20 sham TMSr
Other Names:
  • TMS
  • Sham Stimulation
  • Cocaine Addiction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minnesota Cocaine Craving Scale(MCCS)
Time Frame: 2 months
Reduction on the scores of MCCS
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barrat Impulsiveness Scale vers 11 ( BIS 11)
Time Frame: 2 months
Reduction of scores of BIS 11.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Philip L Ribeiro, MD, Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

December 22, 2010

Last Update Submitted That Met QC Criteria

December 21, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLRIBEIRO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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