Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT06189690

Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder

Led by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente · Updated on 2024-01-03

102

Participants Needed

1

Research Sites

307 weeks

Total Duration

On this page

Sponsors

I

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Lead Sponsor

N

National Council of Science and Technology, Mexico

Collaborating Sponsor

AI-Summary

What this Trial Is About

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-blind placebo-controlled phase consisting of 20 rTMS sessions and a long-term phase, consisting of 2 weekly sessions for 12 weeks. Participants will be clinically assessed pre-treatment (T0), after 20-sessions phase (T1) and after 12-weeks phase (T2) by an interview about psychiatric symptoms. Also, blood will be obtained in the same T0, T1 and T2 to peripheral levels of BDNF determination. Cognitive state will be measured at the same time-points (T0, T1, T2) by paper-pencil and computerized neuropsychological assessment. Researchers will compare active rTMS versus placebo 5 Hz-rTMS on described variables. Additionally, a comparative group (without rTMS intervention) will be included to equivalently measure described variables during periods without cocaine consumption.

CONDITIONS

Official Title

Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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 threshold.
  • 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 provoke 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Instituto Nacional de Psiquiatría Ramón de la Fuente M.

Mexico City, Tlalpan, Mexico, 14370

Actively Recruiting

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Research Team

E

Erik D. Morelos-Santana, Ph D. Candidate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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