Status:
UNKNOWN
Transcranial Magnetic Stimulation for Cocaine Addiction
Lead Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Conditions:
Cocaine Dependence
Substance Use Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Background: Cocaine use disorders (CUD) is a complex brain disorder, involving several brain areas and neurocircuits. Effective treatments for CUD are still needed. Repetitive transcranial magnetic st...
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce craving in cocaine addicts. However, the efficacy of rTMS in treating cocaine addiction has not been evaluated in double-bl...
Eligibility Criteria
Inclusion
- 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
- 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;
- Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures;
- Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient;
- For female patients: Pregnancy/breastfeeding.
- Subjects who have contraindications to MRI. Some of the exclusions are:
- Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity as these make having an MRI unsafe.
- Unable to lie flat on the back for the expected length of the experiment (50 minutes).
- Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis.
- Uncomfortable being in a small space for the expected length of the experiment (50 minutes).
- Non-removable body piercing or tattoo posing MRI risk
- Pregnancy
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03333460
Start Date
October 1 2017
End Date
December 1 2020
Last Update
November 7 2017
Active Locations (2)
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1
Department of Neuroscience, Imaging and Clinical Sciences
Chieti, Italy, 66100
2
La Promessa ONLUS
Rome, Italy, 00192