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

Primary Purpose

Cocaine Dependence

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Placebo TMS
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Transcranial Magnetic Stimulation, Cocaine, impulsivity, rating scale

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active TMS

Placebo TMS

Arm Description

active rTMS delivered to the left dorsolateral prefrontal cortex

PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Outcomes

Primary Outcome Measures

The Short PROMIS Questionnaire
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 (

Secondary Outcome Measures

Full Information

First Posted
May 13, 2011
Last Updated
July 18, 2011
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01397266
Brief Title
Study of the Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence
Acronym
TMSCOCAINE
Official Title
Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
reduction of the rating impulsivity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Transcranial Magnetic Stimulation, Cocaine, impulsivity, rating scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TMS
Arm Type
Active Comparator
Arm Description
active rTMS delivered to the left dorsolateral prefrontal cortex
Arm Title
Placebo TMS
Arm Type
Placebo Comparator
Arm Description
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex
Intervention Type
Procedure
Intervention Name(s)
Placebo TMS
Other Intervention Name(s)
TMS
Intervention Description
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
Primary Outcome Measure Information:
Title
The Short PROMIS Questionnaire
Description
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 (
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994). 20 days or less withdrawal 18-35 years old. If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization). Fixed residential address in Sao Paulo Exclusion criteria: Other Mental Disorders (DSM IV, 1994; SCID-P, 1994). organic brain disease, neurosurgery to implant metal clip or epilepsy. severe uncontrolled clinical comorbidity. use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day. Changes clinically significant laboratory findings. 13 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. Mandate that mandating the judicial treatment for cocaine dependence
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ádan Jardim
Phone
+551130698159
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adan Jardim
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ádan P JArdim
Phone
55 11 30698159
First Name & Middle Initial & Last Name & Degree
Ádan P Jardim

12. IPD Sharing Statement

Learn more about this trial

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

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