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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01259362
First received: December 10, 2010
Last updated: December 21, 2010
Last verified: September 2010

December 10, 2010
December 21, 2010
March 2010
March 2012   (final data collection date for primary outcome measure)
Minnesota Cocaine Craving Scale(MCCS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Reduction on the scores of MCCS
MINNESOTA COCAINE CRAVING SCALE [ Time Frame: 2 MONTHS ] [ Designated as safety issue: No ]
REDUCTION ON THE SCORES OF MINNESOTA COCAINE CRAVING SCALE.
Complete list of historical versions of study NCT01259362 on ClinicalTrials.gov Archive Site
Barrat Impulsiveness Scale vers 11 ( BIS 11) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Reduction of scores of BIS 11.
BARRAT IMPULSIVENESS SCALE 11 [ Time Frame: 2 MONTHS ] [ Designated as safety issue: No ]
REDUCTION OF SCORES OF BIS 11.
Not Provided
Not Provided
 
Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients
Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Cocaine Addiction
  • Treatment
  • Transcranial Magnetic Stimilation
  • Procedure: Transcranial Magnetic Stimulation
    5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
    Other Names:
    • rTMS
    • Cocaine Addiction
    • Cocaine Addiction Treatment
  • Procedure: Transcranial Magnetic Stimulation
    Cocaine addicted will receive 20 sham TMSr
    Other Names:
    • TMS
    • Cocaine Addiction
    • Sham Stimulation
  • Active Comparator: Transcranial Magnetic Stimulation
    Cocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.
    Intervention: Procedure: Transcranial Magnetic Stimulation
  • Sham Comparator: Transcranial Magnetic Stimlation
    cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex
    Intervention: Procedure: Transcranial Magnetic Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact: Philip L Ribeiro, MD 551130698159 philipribeiro@usp.br
Brazil
 
NCT01259362
PLRIBEIRO1
No
Philip Leite Ribeiro, Department and Institute of Psychiatry, General Hospital University of Sao Paulo
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Philip L Ribeiro, MD Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP
University of Sao Paulo General Hospital
September 2010

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