Status:
RECRUITING
Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder
Lead Sponsor:
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study aims to explore the effect of 5-Hz rTMS over the left dorsolateral prefrontal cortex on the BDNF, craving and cognitive function. This study will be longitudinal, with a short-term double-b...
Detailed Description
Brain derived neurotrophic factor (BDNF) is a widely explored neurotrophin in preclinical models of cocaine addiction with relevant phase and region dependent dynamics along addictive cycle. In humans...
Eligibility Criteria
Inclusion
- Current cocaine use disorder according to the Diagnostic and statistical manual of mental disorders (DSM 5).
- Cocaine crack or powder use for at least 12 months with a frequency of 3 times or more per week, with abstinence periods shorter than 1 year for the last year.
- Primary school completed.
Exclusion
- Personal or first degree family history of any neurological disorder including, but not limited to, organic brain syndrome, epilepsy, brain injuries, multiple sclerosis, conditions that increase intracranial pressure.
- Personal history of brain surgery or traumatic brain injury.
- Comorbilities that could represent a risk of neuroinfection or increased convulsive threshoid.
- Other than alcohol, tobacco or marijuana substance use disorder.
- If the patient does not meet the safety criteria for rTMS.
- Current use of any medication that might provoque seizures or any anticonvulsant drugs.
- Personal history of schizophrenia, mania/hypomania or OCD.
- Personal history of myocardial infarction, angina, congestive heart failure, cerebrovascular events, transient ischemic attack or any other heart condition currently undergoing medical treatment.
- Personal history of seizures or detection of paroxysmal EEG activity.
Key Trial Info
Start Date :
January 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06189690
Start Date
January 6 2022
End Date
December 1 2027
Last Update
January 3 2024
Active Locations (1)
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1
Instituto Nacional de Psiquiatría Ramón de la Fuente M.
Mexico City, Tlalpan, Mexico, 14370