Effect of rTMS on Neurotrophines Levels in CUD (BDNFcoca)
Cocaine Use, Cocaine Dependence, Cocaine Abuse
About this trial
This is an interventional basic science trial for Cocaine Use focused on measuring rTMS, BDNF, proBDNF, Cocaine Use Disorder
Eligibility Criteria
Inclusion Criteria (for CUD patient): Current diagnosis of cocaine use disorder (from moderate to severe), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5); Abstinence from cocaine for at least 48 hrs. Exclusion Criteria (for CUD patient): Current DSM-5 diagnosis of substance and/or alcohol use disorders other than nicotine; Current DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder; Use in the past 4 weeks of any medication with known pro-convulsant action; or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers); Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes; Inclusion Criteria (for HC): 1. 18-65 years Exclusion Criteria (for CUD patient): Current DSM-5 diagnosis of substance use disorders other than nicotine; Current DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
Sites / Locations
- ITAB
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Sham Comparator
No Intervention
Active rTMS (15 Hz)
Sham rTMS
Healthy Control
Active stimulation of LDLPFC (15 Hz; 100% of RMT; 40 trains with 60 stimuli per train; inter-train interval of 15 second, total duration 13 minutes). Each session will be repeated twice/daily for 10 consecutive days for 2 weeks, during the continued treatment phase. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).
A pre-programmed software set sham stimulation by a staff member that will not be involved in data collection and analysis. The sham condition will match the number of pulses delivered during the 15Hz session and will use the same coil placement but the intensity of stimulation will be set a 3% of the RMT so to ensure that the participant will feel similar scalp sensations experienced by participants receiving active rTMS, but brain tissue will not be stimulated. Device: MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).
Subject without diagnosis of Cocaine Use Disorder or other major psychiatric disorder.