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

July 18, 2011 updated by: University of Sao Paulo General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

reduction of the rating impulsivity

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ádan Jardim
  • Phone Number: +551130698159

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
        • Contact:
          • Ádan P JArdim
          • Phone Number: 55 11 30698159
        • Principal Investigator:
          • Ádan P Jardim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Short PROMIS Questionnaire
Time Frame: 2 months

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 (
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Adan Jardim, University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

July 19, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1339/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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