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

Cocaine Dependence Clinical Trial

— TMSCOCAINE  

Official title:

Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01397266
• Other study ID #: 1339/09
• Status: Recruiting
• Phase: Phase 2
• First received: May 13, 2011
• Last updated: July 18, 2011
• Start date: March 2010
• Est. completion date: July 2013

Study information

• Verified date: August 2010
• Source: University of Sao Paulo General Hospital
• Contact: Ádan Jardim
• Phone: +551130698159
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

reduction of the rating impulsivity

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 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 Dependence
• Cocaine-Related Disorders
• Impulsive Behavior

Intervention

Procedure:
• Transcranial Magnetic Stimulation
ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex
• Placebo TMS
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Locations

Country	Name	City	State
Brazil	Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School	São Paulo

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	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 (	2 months	No