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

Treatment Clinical Trial

— TMSCOCDEPEND  

Official title:

Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01259362
• Other study ID #: PLRIBEIRO1
• Status: Recruiting
• Phase: Phase 2
• First received: December 10, 2010
• Last updated: December 21, 2010
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: September 2010
• Source: University of Sao Paulo General Hospital
• Contact: Philip L Ribeiro, MD
• Phone: 551130698159
• Email: philipribeiro[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Addiction
• Transcranial Magnetic Stimilation
• Treatment

Intervention

Procedure:
• Transcranial Magnetic Stimulation
5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
• Transcranial Magnetic Stimulation
Cocaine addicted will receive 20 sham TMSr

Locations

Country	Name	City	State
Brazil	Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minnesota Cocaine Craving Scale(MCCS)	Reduction on the scores of MCCS	2 months	No
Secondary	Barrat Impulsiveness Scale vers 11 ( BIS 11)	Reduction of scores of BIS 11.	2 months	No