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Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence (TMSCOCAINE)

This study is currently recruiting participants.
Verified August 2010 by University of Sao Paulo General Hospital
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01397266
First received: May 13, 2011
Last updated: July 18, 2011
Last verified: August 2010
History of Changes
  Purpose

In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.


Condition Intervention Phase
Cocaine Dependence
 Procedure: Transcranial Magnetic Stimulation
Procedure: Placebo TMS
 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: Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • The Short PROMIS Questionnaire [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    The SPQ is a 160-question paper that counsellors and researchers can use to measure an individual's level of addictive tendency in each of sixteen distinct behavioural areas. Will be applied at the following times:

    T0 (weeks 0 - immediately prior to the rTMS) T1 (4 weeks, after four weeks of treatment with rTMS) and T2 (8 weeks, four weeks after completing treatment).

    The improvement rate of 10% or more, will be our primary measure of efficacy. T0 (



Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active TMS
active rTMS delivered to the left dorsolateral prefrontal cortex
 Procedure: Transcranial Magnetic Stimulation
ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex
Other Name: TMS
Placebo Comparator: Placebo TMS
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
 Procedure: Placebo TMS
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
Other Name: TMS

Detailed Description:

reduction of the rating impulsivity

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
  2. 20 days or less withdrawal
  3. 18-35 years old.
  4. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
  5. Fixed residential address in Sao Paulo

Exclusion criteria:

  1. Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
  2. organic brain disease, neurosurgery to implant metal clip or epilepsy.
  3. severe uncontrolled clinical comorbidity.
  4. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
  5. Changes clinically significant laboratory findings. 13
  6. Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.
  7. Mandate that mandating the judicial treatment for cocaine dependence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397266

Contacts
Contact: Ádan Jardim +551130698159

Locations
Brazil
Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School Recruiting
São Paulo, Brazil
Contact: Ádan P JArdim     55 11 30698159        
Principal Investigator: Ádan P Jardim            
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Adan Jardim University of Sao Paulo General Hospital
  More Information

No publications provided

Responsible Party: Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence, USaoPauloGH
ClinicalTrials.gov Identifier: NCT01397266     History of Changes
Other Study ID Numbers: 1339/09
Study First Received: May 13, 2011
Last Updated: July 18, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Transcranial Magnetic Stimulation
Cocaine
impulsivity
rating scale

Additional relevant MeSH terms:
Impulsive Behavior
Cocaine-Related Disorders
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 17, 2013