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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01397266
Acronym
TMSCOCAINE
Enrollment
20
Registered
2011-07-19
Start date
2010-03-31
Completion date
2013-07-31
Last updated
2011-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Dependence

Keywords

Transcranial Magnetic Stimulation, Cocaine, impulsivity, rating scale

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.

Detailed description

reduction of the rating impulsivity

Interventions

PROCEDURETranscranial Magnetic Stimulation

ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex

PROCEDUREPlacebo TMS

PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Short PROMIS Questionnaire2 monthsThe 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 (

Countries

Brazil

Contacts

Primary ContactÁdan Jardim
+551130698159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026