Phase
Condition
Stimulant Use Disorder
Treatment
N/AClinical Study ID
Ages 18-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, withabstinence 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 ofelementary 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 medicallyacceptable form of contraception, and to not become pregnant during the duration ofthe study. A woman is considered to have potential for pregnancy, unless she ispostmenopause or surgically sterilized. Female patients of childbearing potentialshould use either: (1) contraceptive pill or hormone preparation IUD or deposit (ring,injection, implant); And / or (2) a barrier method of contraception, such as thediaphragm, spermicide sponge, or a condom. Contraceptive measures will be reviewed with the female subjects at each visit prior to therTMS 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 MagneticResonance.
Exclusion
Exclusion Criteria:
Personal or first-degree family history of any clinically defined neurologicaldisorder, including organic brain disease, epilepsy, brain events, brain injury, ormultiple sclerosis; Or personal history of previous neurosurgery or traumatic braininjury that have produced loss of consciousness.
Cardiac pacemakers, neural stimulators, implantable defibrillators, implantedmedication pumps, intracardiac lines, or acute, unstable heart disease, withintracranial implants (eg, aneurysm clips, leads, stimulators, cochlear implants, orelectrodes) or with any other Metallic object inside or near the head that can not besafely removed.
Screw metal or metallic projectiles into the head or body.
Current use of any investigational drug or any anti-proconvulsant drug such astricyclic 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 heartcondition currently under medical care.
Women with reproductive potential who do not use an acceptable form of contraceptionpregnant or who are lactating.
Any history of seizures.
The current dependence (DSM-V criteria) on substances other than cocaine and / ornicotine.
Claustrophobia making them unable to tolerate lying inside the MRI scanner.
History of HIV infection or HIV antibody test positive (Due to potentialneuroinfection). These data will be corroborated by a screening visit where the following instruments willbe used: Clinical Interview. Self-applicable demographic questionnaire. Mini InternationalNeuropsychiatric Interview (MINI-Plus). Structured clinical interview for DSM Axis II, selfreport (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 thestudy to ensure the health of the participant.
Worsening of clinical condition.
Study Design
Study Description
Connect with a study center
Instituto Nacional de Psiquiatría "Ramón de la Fuente Muñiz"
Mexico City, 14370
MexicoActive - Recruiting
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