RecruitingNot ApplicableNCT06189690

Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder

Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation on Serum Brain Derived Neurotrophic Factor and Clinical Variables in Cocaine Use Disorder

Sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Enrollment

102 participants

Start Date

Jan 6, 2022

Study Type

INTERVENTIONAL

Conditions

Cocaine Dependence

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-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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

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 Criteria9

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.

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Interventions

DEVICErTMS

Repetitive TMS will be administered by a MagPro R30 stimulator and an active/placebo MCF-B70 A/P coil. All participants will use two surface electrodes to simulate rTMS skin sensations near to stimulation site. rTMS/sham conditions will be double-blinded by a USB stick. The USB contains the information about rTMS/sham condition and this is not available to the stimulator operator. Parameters of rTMS were previously described.