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

Primary Purpose

Cocaine Addiction, Treatment, Transcranial Magnetic Stimilation

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation
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 Addiction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimlation

Arm Description

Cocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.

cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex

Outcomes

Primary Outcome Measures

Minnesota Cocaine Craving Scale(MCCS)
Reduction on the scores of MCCS

Secondary Outcome Measures

Barrat Impulsiveness Scale vers 11 ( BIS 11)
Reduction of scores of BIS 11.

Full Information

First Posted
December 10, 2010
Last Updated
December 21, 2010
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01259362
Brief Title
Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients
Acronym
TMSCOCDEPEND
Official Title
Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina
Study Type
Interventional

2. Study Status

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction, Treatment, Transcranial Magnetic Stimilation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
Cocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.
Arm Title
Transcranial Magnetic Stimlation
Arm Type
Sham Comparator
Arm Description
cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
rTMS, Cocaine Addiction, Cocaine Addiction Treatment
Intervention Description
5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS, Cocaine Addiction, Sham Stimulation
Intervention Description
Cocaine addicted will receive 20 sham TMSr
Primary Outcome Measure Information:
Title
Minnesota Cocaine Craving Scale(MCCS)
Description
Reduction on the scores of MCCS
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Barrat Impulsiveness Scale vers 11 ( BIS 11)
Description
Reduction of scores of BIS 11.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip L Ribeiro, MD
Phone
551130698159
Email
philipribeiro@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip L Ribeiro, MD
Organizational Affiliation
Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip L Ribeiro, md
Phone
551130698159
Email
philipribeiro@usp.br
First Name & Middle Initial & Last Name & Degree
Philip L Ribeiro, MD

12. IPD Sharing Statement

Learn more about this trial

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

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