Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients
TMSCOCDEPEND
Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 10, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 22, 2010
September 1, 2010
2 years
December 10, 2010
December 21, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Minnesota Cocaine Craving Scale(MCCS)
Reduction on the scores of MCCS
2 months
Secondary Outcomes (1)
Barrat Impulsiveness Scale vers 11 ( BIS 11)
2 months
Study Arms (2)
Transcranial Magnetic Stimulation
ACTIVE COMPARATORCocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex.
Transcranial Magnetic Stimlation
SHAM COMPARATORcocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex
Interventions
5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
Eligibility Criteria
You may qualify if:
- Minimum age of 18
- Maximum age of 40
- Diagnostic of Cocaine addiction
- Willingly participate the study
You may not qualify if:
- Metallic Cerebral Implant
- History of Severe Brain trauma or injury
- Organic Brain Disease
- Severe Somatic Disease
- History of other actual or past psychiatric diagnostics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
São Paulo, São Paulo, 05403010, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip L Ribeiro, MD
Post Graduate Student Department of Brain Stimulation - IPQ - HC FMUSP
Central Study Contacts
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
December 10, 2010
First Posted
December 14, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2012
Study Completion
July 1, 2012
Last Updated
December 22, 2010
Record last verified: 2010-09