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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01259362
First received: December 10, 2010
Last updated: December 21, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Cocaine Addiction
Treatment
Transcranial Magnetic Stimilation
 Procedure: Transcranial Magnetic Stimulation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Minnesota Cocaine Craving Scale(MCCS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Reduction on the scores of MCCS


Secondary Outcome Measures:
  • Barrat Impulsiveness Scale vers 11 ( BIS 11) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Reduction of scores of BIS 11.


Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259362

Contacts
Contact: Philip L Ribeiro, MD 551130698159 philipribeiro@usp.br

Locations
Brazil
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     philipribeiro@usp.br    
Sub-Investigator: Philip L Ribeiro, MD            
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Philip L Ribeiro, MD Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP
  More Information

No publications provided

Responsible Party: Philip Leite Ribeiro, Department and Institute of Psychiatry, General Hospital University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01259362     History of Changes
Other Study ID Numbers: PLRIBEIRO1
Study First Received: December 10, 2010
Last Updated: December 21, 2010
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013