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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01259362
Recruitment Status : Unknown
Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : December 14, 2010
Last Update Posted : December 22, 2010
Information provided by:
University of Sao Paulo General Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Treatment Transcranial Magnetic Stimilation Procedure: Transcranial Magnetic Stimulation Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina
Study Start Date : March 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Sham Comparator: Transcranial Magnetic Stimlation
cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex
Procedure: Transcranial Magnetic Stimulation
Cocaine addicted will receive 20 sham TMSr
Other Names:
  • TMS
  • Cocaine Addiction
  • Sham Stimulation

Primary Outcome Measures :
  1. Minnesota Cocaine Craving Scale(MCCS) [ Time Frame: 2 months ]
    Reduction on the scores of MCCS

Secondary Outcome Measures :
  1. Barrat Impulsiveness Scale vers 11 ( BIS 11) [ Time Frame: 2 months ]
    Reduction of scores of BIS 11.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01259362

Contact: Philip L Ribeiro, MD 551130698159

Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school Recruiting
Sao Paulo, SP, Brazil, 05403010
Contact: Philip L Ribeiro, md    551130698159   
Sub-Investigator: Philip L Ribeiro, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Principal Investigator: Philip L Ribeiro, MD Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP

Responsible Party: Philip Leite Ribeiro, Department and Institute of Psychiatry, General Hospital University of Sao Paulo Identifier: NCT01259362     History of Changes
Other Study ID Numbers: PLRIBEIRO1
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents