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

NCT01397266 | Unknown Phase 2

• 1 other identifier: 1339/09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

Transcranial Magnetic Stimulation; Cocaine; impulsivity; rating scale

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active TMS

ACTIVE COMPARATOR

active rTMS delivered to the left dorsolateral prefrontal cortex

Procedure: Transcranial Magnetic Stimulation

Placebo TMS

PLACEBO COMPARATOR

PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Procedure: Placebo TMS

Interventions

Transcranial Magnetic Stimulation PROCEDURE

ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex

Also known as: TMS

Active TMS

Placebo TMS PROCEDURE

PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Also known as: TMS

Placebo TMS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
• days or less withdrawal
• years old.
• If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
• Fixed residential address in Sao Paulo

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Cocaine-Related Disorders; Impulsive Behavior

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Adan Jardim

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ádan Jardim

CONTACT

+551130698159

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: July 19, 2011
• Study Start: March 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2013
• Last Updated: July 19, 2011

Record last verified: 2010-08

Locations

BR (1)