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

Overview

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.

Full Title of Study: “Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2012

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.

Interventions

  • Procedure: Transcranial Magnetic Stimulation
    • 5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
  • Procedure: Transcranial Magnetic Stimulation
    • Cocaine addicted will receive 20 sham TMSr

Arms, Groups and Cohorts

  • Active Comparator: Transcranial Magnetic Stimulation
    • Cocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.
  • Sham Comparator: Transcranial Magnetic Stimlation
    • cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo General Hospital
  • Provider of Information About this Clinical Study
    • Philip Leite Ribeiro, Department and Institute of Psychiatry, General Hospital University of Sao Paulo
  • Overall Official(s)
    • Philip L Ribeiro, MD, Principal Investigator, Post Graduate Student Department of Brain Stimulation – IPQ – HC FMUSP
  • Overall Contact(s)
    • Philip L Ribeiro, MD, 551130698159, philipribeiro@usp.br

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