<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02986438</url>
  </required_header>
  <id_info>
    <org_study_id>IC16036.0</org_study_id>
    <nct_id>NCT02986438</nct_id>
  </id_info>
  <brief_title>Treatment With Transcranial Magnetic Stimulation for Cocaine Addiction: Clinical Response and Functional Connectivity.</brief_title>
  <acronym>TMS_COC_CONN</acronym>
  <official_title>Effects of Transcranial Magnetic Stimulation on Functional Connectivity and Response to Treatment of Cocaine Dependent Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the short and long term clinical and cognitive&#xD;
      effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz&#xD;
      frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to&#xD;
      examine possible changes in brain structure and functional connectivity associated with this&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce craving in&#xD;
      cocaine addicts in the short term. However, there are no studies on the long term clinical&#xD;
      and cognitive effects of sustained rTMS therapy. Moreover, clinical improvement or decline&#xD;
      could be related to long term changes in brain structure and function. The purpose of this&#xD;
      study is to investigate the short and long term clinical and cognitive effects of repetitive&#xD;
      Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz frequencies on the left&#xD;
      dorsolateral prefrontal cortex in cocaine dependent patients and to examine possible changes&#xD;
      in brain structure and functional connectivity associated with this intervention. For this&#xD;
      purpose the investigators will recruit cocaine dependent patients and stimulate them using&#xD;
      rTMS with a acute intervention (twice a day for 2 weeks) and a maintenance intervention&#xD;
      (twice a week for 3 months). The investigators will follow the patients to determine clinical&#xD;
      outcome. The investigators will also measure clinical, cognitive and brain structural and&#xD;
      functional connectivity to asses changes related to the intervention in the short and long&#xD;
      term (measurements at: baseline, 2 weeks and 3 months).&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      The projects consists of: Screening Visit, Part 1 and Part 2.&#xD;
&#xD;
      First, there will be a screening visit, where a clinical interview will be conducted and&#xD;
      tests will be applied to select study participants who meet the inclusion and exclusion&#xD;
      criteria.&#xD;
&#xD;
      Baseline clinical, cognitive and neuroimaging data will be acquired. The cognitive and&#xD;
      neuroimaging data will be exploratory, to be associated with the outcome measures. Part 1 of&#xD;
      the study entails the determination of the rTMS target frequency (5 or 10 Hz) for Part 2&#xD;
      (long term stimulation). In Part 1, all participants will be randomly assigned to one of the&#xD;
      four treatment legs with rTMS (10Hz, 10Hz-Sham, 5Hz, 5Hz-Sham). Participants will receive 20&#xD;
      sessions of rTMS (intervention or sham), twice per day for 10 consecutive days. Each session&#xD;
      lasts approximately 35 minutes.&#xD;
&#xD;
      At 2 weeks, the investigators will evaluate the short term effect of treatment by measuring&#xD;
      clinical, cognitive and neuroimaging changes and select which frequency of stimulation is the&#xD;
      most effective in terms of clinical improvement, but also in terms of the rate of secondary&#xD;
      effects. Our hypothesis is that 5 Hz is as effective as 10 Hz without the high rate of&#xD;
      secondary effects (i.e. seizures).&#xD;
&#xD;
      In Part 2 of the study, the sham groups will end and they will be invited to the treatment&#xD;
      condition although they data not will be considered for later phases. Here the maintenance&#xD;
      phase starts (long term), where rTMS will be performed twice a week for 12 months using the&#xD;
      target frequency (5 or 10 Hz). Clinical, cognitive and neuroimaging data will be acquired at&#xD;
      2 weeks and 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Double-blind randomized control trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cocaine Craving (CCQ)</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>The craving will be measured using a craving questionnaire for cocaine validated in Mexican population (Cocaine Craving Questionnaire or CCQ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cocaine Craving (VAS)</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>The craving will be measured using a 100 mm visual analogue scales (VAS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cocaine Urine Test</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Frequency of cocaine use will be measured using reagent strips from Instant View drug screening (&gt; 300 ng/mL). Results are Positive or Negative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Psychopathological Symptoms</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Measured by the 90 Symptoms Questionnaire (SCL-90).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Depression</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Measured by Hamilton Depression Rating Scale (HDRS) (21 items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Anxiety</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Measured by Hamilton Anxiety Rating Scale (HARS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Drug Consumption and Related Problems</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Measured by the Addiction Severity Index (ASI-lite).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Sleep Quality: PSQI</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Measured by the Pittsburgh Sleep Quality Index (PSQI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Impulsivity</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Measured by the Barrat Impulsivity Scale-11 (BIS-11).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lapse rate</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Lapse is defined as at least one consumption event not in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse rate</measure>
    <time_frame>Baseline, 2 weeks, 3 months</time_frame>
    <description>Relapse is defined as consumption events in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cocaine-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Active rTMS frequency at 5 Hz</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham rTMS frequency at 5 Hz</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive Transcranial Magnetic Stimulation</intervention_name>
    <description>The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral.&#xD;
Each patient will receive consistent treatment in 2 sessions a day for 10 consecutive business days in the first two weeks, then receive 2 weekly sessions, until the year of treatment is completed. Each session will consist of the application of 30 trains of 10 seconds duration separated by intervals of one minute, at a fixed frequency (5Hz or 10Hz), to 100% of the motor threshold.</description>
    <arm_group_label>Active rTMS frequency at 5 Hz</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive Transcranial Magnetic Stimulation (Sham)</intervention_name>
    <description>The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral with a coil that allows simulated stimulation (Coil AP).&#xD;
This condition will only last two weeks.</description>
    <arm_group_label>Sham rTMS frequency at 5 Hz</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age of eighteen and maximum of fifty years.&#xD;
&#xD;
          -  Cocaine users for at least 1 year, currently using at least 3 times a week, with&#xD;
             abstinence periods continuing to be less than one month in the last year.&#xD;
&#xD;
          -  The reading level of at least 6th grade of primary (equivalent to fifth grade of&#xD;
             elementary school).&#xD;
&#xD;
          -  The ability to give a valid informed consent.&#xD;
&#xD;
          -  Right-handed (in order to control by cerebral laterality in Neuroimaging).&#xD;
&#xD;
          -  If the subject is female and of childbearing age, she agrees to use a medically&#xD;
             acceptable form of contraception, and to not become pregnant during the duration of&#xD;
             the study. A woman is considered to have potential for pregnancy, unless she is&#xD;
             postmenopause or surgically sterilized. Female patients of childbearing potential&#xD;
             should use either: (1) contraceptive pill or hormone preparation IUD or deposit (ring,&#xD;
             injection, implant); And / or (2) a barrier method of contraception, such as the&#xD;
             diaphragm, spermicide sponge, or a condom.&#xD;
&#xD;
        Contraceptive measures will be reviewed with the female subjects at each visit prior to the&#xD;
        rTMS treatment.&#xD;
&#xD;
          -  Self-report of experiencing cocaine craving when exposed to cocaine-associated cues.&#xD;
&#xD;
          -  Body mass index less or equal to 30, allowing them to safely enter the Magnetic&#xD;
             Resonance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal or first-degree family history of any clinically defined neurological&#xD;
             disorder, including organic brain disease, epilepsy, brain events, brain injury, or&#xD;
             multiple sclerosis; Or personal history of previous neurosurgery or traumatic brain&#xD;
             injury that have produced loss of consciousness.&#xD;
&#xD;
          -  Cardiac pacemakers, neural stimulators, implantable defibrillators, implanted&#xD;
             medication pumps, intracardiac lines, or acute, unstable heart disease, with&#xD;
             intracranial implants (eg, aneurysm clips, leads, stimulators, cochlear implants, or&#xD;
             electrodes) or with any other Metallic object inside or near the head that can not be&#xD;
             safely removed.&#xD;
&#xD;
          -  Screw metal or metallic projectiles into the head or body.&#xD;
&#xD;
          -  Current use of any investigational drug or any anti-proconvulsant drug such as&#xD;
             tricyclic or neuroleptic antidepressants (which reduce the seizure threshold).&#xD;
&#xD;
          -  Increased intracranial pressure (decreasing seizure threshold).&#xD;
&#xD;
          -  History of schizophrenia, bipolar disorder, mania or hypomania.&#xD;
&#xD;
          -  History of myocardial infarction, angina pectoris, congestive heart failure,&#xD;
             cardiomyopathy, cerebrovascular events or transient ischemic attack, or any heart&#xD;
             condition currently under medical care.&#xD;
&#xD;
          -  Women with reproductive potential who do not use an acceptable form of contraception&#xD;
             pregnant or who are lactating.&#xD;
&#xD;
          -  Any history of seizures.&#xD;
&#xD;
          -  The current dependence (DSM-V criteria) on substances other than cocaine and / or&#xD;
             nicotine.&#xD;
&#xD;
          -  Claustrophobia making them unable to tolerate lying inside the MRI scanner.&#xD;
&#xD;
          -  History of HIV infection or HIV antibody test positive (Due to potential&#xD;
             neuroinfection).&#xD;
&#xD;
        These data will be corroborated by a screening visit where the following instruments will&#xD;
        be used:&#xD;
&#xD;
        Clinical Interview. Self-applicable demographic questionnaire. Mini International&#xD;
        Neuropsychiatric Interview (MINI-Plus). Structured clinical interview for DSM Axis II, self&#xD;
        report (SCID-II).&#xD;
&#xD;
        Elimination criteria:&#xD;
&#xD;
        The participation of all participants during the study will be suspended if:&#xD;
&#xD;
          -  They express their desire to stop participating.&#xD;
&#xD;
          -  They present abnormal radiological findings that require more attention outside the&#xD;
             study to ensure the health of the participant.&#xD;
&#xD;
          -  Worsening of clinical condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo A Garza-Villarreal, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Nacional Autonoma de Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ruth Alcala-Lozano, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Psiquiatria &quot;Ramon de la Fuente Muñiz&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruth Alcala-Lozano, MD, MSc</last_name>
    <phone>+52(55)41605065</phone>
    <email>ruthalcala_@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto Nacional de Psiquiatría &quot;Ramón de la Fuente Muñiz&quot;</name>
      <address>
        <city>Mexico City</city>
        <zip>14370</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruth Alcala, MD, MSc</last_name>
      <phone>+52(55)41605065</phone>
      <email>ruthalcala_@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente</investigator_affiliation>
    <investigator_full_name>Jorge J. González Olvera</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cocaine</keyword>
  <keyword>Addiction</keyword>
  <keyword>rTMS</keyword>
  <keyword>fMRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the main publications by the group are released, all data (clinical, cognitive and neuroimaging) will be uploaded to an online open server such as LONI or OpenfMRI, for example.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02986438
org study id: IC16036.0
nct id: NCT02986438
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to investigate the short and long term clinical and cognitive
      effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz
      frequencies on the left dorsolateral prefrontal cortex in cocaine dependent patients and to
      examine possible changes in brain structure and functional connectivity associated with this
      intervention.
Repetitive transcranial magnetic stimulation (rTMS) has been shown to reduce craving in
      cocaine addicts in the short term. However, there are no studies on the long term clinical
      and cognitive effects of sustained rTMS therapy. Moreover, clinical improvement or decline
      could be related to long term changes in brain structure and function. The purpose of this
      study is to investigate the short and long term clinical and cognitive effects of repetitive
      Transcranial Magnetic Stimulation (rTMS) at 5 Hz and/or 10 Hz frequencies on the left
      dorsolateral prefrontal cortex in cocaine dependent patients and to examine possible changes
      in brain structure and functional connectivity associated with this intervention. For this
      purpose the investigators will recruit cocaine dependent patients and stimulate them using
      rTMS with a acute intervention (twice a day for 2 weeks) and a maintenance intervention
      (twice a week for 3 months). The investigators will follow the patients to determine clinical
      outcome. The investigators will also measure clinical, cognitive and brain structural and
      functional connectivity to asses changes related to the intervention in the short and long
      term (measurements at: baseline, 2 weeks and 3 months).

      Procedure:

      The projects consists of: Screening Visit, Part 1 and Part 2.

      First, there will be a screening visit, where a clinical interview will be conducted and
      tests will be applied to select study participants who meet the inclusion and exclusion
      criteria.

      Baseline clinical, cognitive and neuroimaging data will be acquired. The cognitive and
      neuroimaging data will be exploratory, to be associated with the outcome measures. Part 1 of
      the study entails the determination of the rTMS target frequency (5 or 10 Hz) for Part 2
      (long term stimulation). In Part 1, all participants will be randomly assigned to one of the
      four treatment legs with rTMS (10Hz, 10Hz-Sham, 5Hz, 5Hz-Sham). Participants will receive 20
      sessions of rTMS (intervention or sham), twice per day for 10 consecutive days. Each session
      lasts approximately 35 minutes.

      At 2 weeks, the investigators will evaluate the short term effect of treatment by measuring
      clinical, cognitive and neuroimaging changes and select which frequency of stimulation is the
      most effective in terms of clinical improvement, but also in terms of the rate of secondary
      effects. Our hypothesis is that 5 Hz is as effective as 10 Hz without the high rate of
      secondary effects (i.e. seizures).

      In Part 2 of the study, the sham groups will end and they will be invited to the treatment
      condition although they data not will be considered for later phases. Here the maintenance
      phase starts (long term), where rTMS will be performed twice a week for 12 months using the
      target frequency (5 or 10 Hz). Clinical, cognitive and neuroimaging data will be acquired at
      2 weeks and 3 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind randomized control trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Cocaine Craving (CCQ)
time frame: Baseline, 2 weeks, 3 months
description: The craving will be measured using a craving questionnaire for cocaine validated in Mexican population (Cocaine Craving Questionnaire or CCQ).
measure: Change in Cocaine Craving (VAS)
time frame: Baseline, 2 weeks, 3 months
description: The craving will be measured using a 100 mm visual analogue scales (VAS).
measure: Change in Cocaine Urine Test
time frame: Baseline, 2 weeks, 3 months
description: Frequency of cocaine use will be measured using reagent strips from Instant View drug screening (> 300 ng/mL). Results are Positive or Negative.
measure: Changes in Psychopathological Symptoms
time frame: Baseline, 2 weeks, 3 months
description: Measured by the 90 Symptoms Questionnaire (SCL-90).
measure: Changes in Depression
time frame: Baseline, 2 weeks, 3 months
description: Measured by Hamilton Depression Rating Scale (HDRS) (21 items).
measure: Changes in Anxiety
time frame: Baseline, 2 weeks, 3 months
description: Measured by Hamilton Anxiety Rating Scale (HARS).
measure: Changes in Drug Consumption and Related Problems
time frame: Baseline, 2 weeks, 3 months
description: Measured by the Addiction Severity Index (ASI-lite).
measure: Changes in Sleep Quality: PSQI
time frame: Baseline, 2 weeks, 3 months
description: Measured by the Pittsburgh Sleep Quality Index (PSQI).
measure: Changes in Impulsivity
time frame: Baseline, 2 weeks, 3 months
description: Measured by the Barrat Impulsivity Scale-11 (BIS-11).
measure: Lapse rate
time frame: Baseline, 2 weeks, 3 months
description: Lapse is defined as at least one consumption event not in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.
measure: Relapse rate
time frame: Baseline, 2 weeks, 3 months
description: Relapse is defined as consumption events in the same pattern as the baseline consumption. The report of self-consumption of cocaine and urine drug tests, with special attention to the presence of traces of cocaine.
arm group label: Active rTMS frequency at 5 Hz
arm group type: Active Comparator
description: 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.
arm group label: Sham rTMS frequency at 5 Hz
arm group type: Sham Comparator
description: 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.
intervention type: Device
intervention name: Repetitive Transcranial Magnetic Stimulation
description: The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral.
Each patient will receive consistent treatment in 2 sessions a day for 10 consecutive business days in the first two weeks, then receive 2 weekly sessions, until the year of treatment is completed. Each session will consist of the application of 30 trains of 10 seconds duration separated by intervals of one minute, at a fixed frequency (5Hz or 10Hz), to 100% of the motor threshold.
arm group label: Active rTMS frequency at 5 Hz
intervention type: Device
intervention name: Repetitive Transcranial Magnetic Stimulation (Sham)
description: The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral with a coil that allows simulated stimulation (Coil AP).
This condition will only last two weeks.
arm group label: Sham rTMS frequency at 5 Hz
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Eduardo A Garza-Villarreal, MD, PHD
role: Principal Investigator
affiliation: Universidad Nacional Autonoma de Mexico
last name: Ruth Alcala-Lozano, MD, MSc
role: Principal Investigator
affiliation: Instituto Nacional de Psiquiatria "Ramon de la Fuente Muñiz"
last name: Ruth Alcala-Lozano, MD, MSc
phone: +52(55)41605065
email: ruthalcala_@hotmail.com
facility: 
status: Recruiting
contact: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
investigator full name: Jorge J. González Olvera
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
sharing ipd: Yes
ipd description: After the main publications by the group are released, all data (clinical, cognitive and neuroimaging) will be uploaded to an online open server such as LONI or OpenfMRI, for example.