We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259362
First Posted: December 14, 2010
Last Update Posted: December 22, 2010
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.
Information provided by:
University of Sao Paulo General Hospital
  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
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

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • Barrat Impulsiveness Scale vers 11 ( BIS 11) [ Time Frame: 2 months ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 10, 2010
First Posted: December 14, 2010
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
Cocaine
Anesthetics, Local
Anesthetics
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