Treatment With Transcranial Magnetic Stimulation for Cocaine Addiction: Clinical Response and Functional Connectivity. (TMS_COC_CONN)
Cocaine-Related Disorders
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine, Addiction, rTMS, fMRI
Eligibility Criteria
Inclusion Criteria:
- Minimum age of eighteen and maximum of fifty years.
- Cocaine users for at least 1 year, currently using at least 3 times a week, with abstinence periods continuing to be less than one month in the last year.
- The reading level of at least 6th grade of primary (equivalent to fifth grade of elementary school).
- The ability to give a valid informed consent.
- Right-handed (in order to control by cerebral laterality in Neuroimaging).
- If the subject is female and of childbearing age, she agrees to use a medically acceptable form of contraception, and to not become pregnant during the duration of the study. A woman is considered to have potential for pregnancy, unless she is postmenopause or surgically sterilized. Female patients of childbearing potential should use either: (1) contraceptive pill or hormone preparation IUD or deposit (ring, injection, implant); And / or (2) a barrier method of contraception, such as the diaphragm, spermicide sponge, or a condom.
Contraceptive measures will be reviewed with the female subjects at each visit prior to the rTMS treatment.
- Self-report of experiencing cocaine craving when exposed to cocaine-associated cues.
- Body mass index less or equal to 30, allowing them to safely enter the Magnetic Resonance.
Exclusion Criteria:
- Personal or first-degree family history of any clinically defined neurological disorder, including organic brain disease, epilepsy, brain events, brain injury, or multiple sclerosis; Or personal history of previous neurosurgery or traumatic brain injury that have produced loss of consciousness.
- Cardiac pacemakers, neural stimulators, implantable defibrillators, implanted medication pumps, intracardiac lines, or acute, unstable heart disease, with intracranial implants (eg, aneurysm clips, leads, stimulators, cochlear implants, or electrodes) or with any other Metallic object inside or near the head that can not be safely removed.
- Screw metal or metallic projectiles into the head or body.
- Current use of any investigational drug or any anti-proconvulsant drug such as tricyclic or neuroleptic antidepressants (which reduce the seizure threshold).
- Increased intracranial pressure (decreasing seizure threshold).
- History of schizophrenia, bipolar disorder, mania or hypomania.
- History of myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, cerebrovascular events or transient ischemic attack, or any heart condition currently under medical care.
- Women with reproductive potential who do not use an acceptable form of contraception pregnant or who are lactating.
- Any history of seizures.
- The current dependence (DSM-V criteria) on substances other than cocaine and / or nicotine.
- Claustrophobia making them unable to tolerate lying inside the MRI scanner.
- History of HIV infection or HIV antibody test positive (Due to potential neuroinfection).
These data will be corroborated by a screening visit where the following instruments will be used:
Clinical Interview. Self-applicable demographic questionnaire. Mini International Neuropsychiatric Interview (MINI-Plus). Structured clinical interview for DSM Axis II, self report (SCID-II).
Elimination criteria:
The participation of all participants during the study will be suspended if:
- They express their desire to stop participating.
- They present abnormal radiological findings that require more attention outside the study to ensure the health of the participant.
- Worsening of clinical condition.
Sites / Locations
- Instituto Nacional de Psiquiatría "Ramón de la Fuente Muñiz"Recruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Active rTMS frequency at 5 Hz
Sham rTMS frequency at 5 Hz
The intervention will be Repetitive Transcranial Magnetic Stimulation. Each patient will receive treatment stimulation in the left dorsolateral prefrontal cortex (lDLPFC) with a frequency of 5 Hz, that includes 2 sessions per day for 10 consecutive business days for 2 weeks. Then a target frequency will be determined for the remaining of the study. If this arm's target frequency is chosen, then the participants will receive the maintenance intervention of 2 sessions per week for 12 months. Each session will consist of the application of rTMS at a frequency of 5Hz, to 100% of the motor threshold.
The intervention will be Repetitive Transcranial Magnetic Stimulation (Sham). rTMS will be used with a coil that allows simulated stimulation (Coil AP) at a frequency of 5 Hz, with the software necessary for the operator to remain blind to the stimulation condition. This arm will only last for 2 weeks.