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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

May 13, 2011
July 18, 2011
March 2010
January 2012   (final data collection date for primary outcome measure)
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 (
Same as current
Complete list of historical versions of study NCT01397266 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence
Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.

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.

reduction of the rating impulsivity
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Dependence
  • Procedure: Transcranial Magnetic Stimulation
    ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex
    Other Name: TMS
  • Procedure: Placebo TMS
    PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
    Other Name: TMS
  • Active Comparator: Active TMS
    active rTMS delivered to the left dorsolateral prefrontal cortex
    Intervention: Procedure: Transcranial Magnetic Stimulation
  • Placebo Comparator: Placebo TMS
    PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
    Intervention: Procedure: Placebo TMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2013
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
No
Contact: Ádan Jardim +551130698159
Brazil
 
NCT01397266
1339/09
No
Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence, USaoPauloGH
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Adan Jardim University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP