<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/NCT03833583</url>
  </required_header>
  <id_info>
    <org_study_id>SMIN2712-P1</org_study_id>
    <secondary_id>HS# 18-01324, GCO# 18-1920</secondary_id>
    <nct_id>NCT03833583</nct_id>
  </id_info>
  <brief_title>tDCS to Reduce Craving in Cocaine Addiction</brief_title>
  <official_title>Transcranial Direct Current Stimulation (tDCS) to Reduce Craving in Cocaine Addiction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soterix Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Soterix Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in&#xD;
      which low level electrical currents are applied to the scalp in order to alter brain&#xD;
      function. In the present study, tDCS will be administered with the goal of assessing the&#xD;
      tolerability and feasibility of this approach to 1) reduce an individual's level of drug&#xD;
      craving and 2) provide evidence to support the use of this device by the patient for future&#xD;
      unsupervised stimulation in a non-clinical setting.&#xD;
&#xD;
      Research Questions:&#xD;
&#xD;
        -  Can tDCS be used successfully to train cocaine addicted individuals for&#xD;
           self-administration purposes?&#xD;
&#xD;
        -  Can active tDCS be used to decrease drug craving in individuals with cocaine use&#xD;
           disorders?&#xD;
&#xD;
        -  Does active tDCS outperform sham tDCS in reducing drug craving?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ultimate goal of this project is to develop a portable neuromodulatory intervention to&#xD;
      reduce craving in cocaine addiction. This proposed project is in response to NIH/NIDA's&#xD;
      solicitation titled &quot;Development of Portable Neuromodulatory Device for the Treatment of&#xD;
      Substance Use Disorders (SUDs).&quot; The present study aims to evaluate the tolerability and&#xD;
      feasibility of repeated administration of tDCS to reduce drug craving in individuals with&#xD;
      cocaine addiction, with the aim of using these data to support a phase II study and,&#xD;
      ultimately, support of approval of usage of this device without clinical supervision.&#xD;
&#xD;
      The specific objectives are:&#xD;
&#xD;
        1. Establish the feasibility and safety of using tDCS to reduce self-reported cravings in&#xD;
           individuals addicted to cocaine.&#xD;
&#xD;
        2. Train cocaine addicted individuals to self-administer tDCS (under supervision) to test&#xD;
           the feasibility of future home self-administration in this population.&#xD;
&#xD;
      Substance use disorders present a treatment challenge for clinicians, as well as a&#xD;
      socioeconomic burden on individuals and society at large. Cocaine use disorder occurs when&#xD;
      someone experiences clinically significant impairment caused by the recurrent use of cocaine,&#xD;
      including health problems, physical withdrawal with discontinuation of use,&#xD;
      persistent/escalating use, and failure to meet major personal, occupational, or educational&#xD;
      responsibilities. At present, no FDA approved medicines are available to treat cocaine&#xD;
      dependence, and behavioral therapy may be used to treat this addiction, though with limited&#xD;
      efficacy. Drug craving (strong obsessions about and/or irresistible urges or compulsions to&#xD;
      consume a drug) is a central driving force for perpetuation of substance use and subsequent&#xD;
      addiction, as well as relapse after abstinence. Currently, no treatments exist that are&#xD;
      targeted at reducing drug craving, which is intrusive and distressing to patients. The&#xD;
      prefrontal cortex (PFC) plays an important role inhibiting these intrusive cravings. However,&#xD;
      decades of data have shown that PFC activity is impaired in addictions. In this study, our&#xD;
      goal is to increase PFC activity with non-invasive neuromodulation. Given the role of the PFC&#xD;
      in the processing and regulation of craving behavior, this brain region is a key target for&#xD;
      brain stimulation.&#xD;
&#xD;
      This study will recruit individuals with a diagnosis of cocaine use disorder (per DSM-5&#xD;
      criteria) who are receiving treatment for their substance use disorder at Samaritan Daytop&#xD;
      Village (SDV) and other similar treatment facilities (e.g., Phoenix House, Mount Sinai's&#xD;
      network of hospitals and clinics). Patients will be randomly assigned to receive either&#xD;
      active or sham (placebo) tDCS. Participants will receive 20 minutes of stimulation per tDCS&#xD;
      day, three days per week for five weeks.&#xD;
&#xD;
      Interviews and neuropsychological testing will be conducted, and self-reported drug craving&#xD;
      and addiction severity questionnaires will be used. Follow up cognitive and behavioral&#xD;
      assessments will be conducted over a period of 12 months post tDCS stimulation. In addition,&#xD;
      participants will be asked to perform EEG, cognitive tasks, and collection of a blood sample&#xD;
      to assess genetic/epigenetic patterns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</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>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)</measure>
    <time_frame>Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)</time_frame>
    <description>Craving for cocaine will be assessed with a brief scale composed of 5 items (1, 2, 4, 5, and 13) from the Obsessive-Compulsive Cocaine Scale (OCCS; Vorspan et al., 2012).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Depression symptoms from Baseline (Ham-D score)</measure>
    <time_frame>Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)</time_frame>
    <description>Depression symptoms will be assessed by the Hamilton Rating Scale for Depression (24 item version, HAM-D; Hamilton, 1960).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety symptoms from Baseline (HAM-A score)</measure>
    <time_frame>Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)</time_frame>
    <description>Anxiety symptoms will be assessed by the Hamilton Rating Scale for Anxiety (HAM-A; Hamilton, 1959).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life from Baseline (WHOQOL-BREF score)</measure>
    <time_frame>Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)</time_frame>
    <description>An abbreviated instrument of cross-culturally valid assessment of quality of life of the World Health Organization (WHOQOL-BREF) with 26 questions (WHOQOL Group, 1998; Skevington et al., 2004) yields 4 domains (physical health, psychological, social relationships, and environment) and 2 individually scored items regarding overall perception of quality of life (Q1) and health (Q2). The 4 domain scores are scaled in a way that higher scores stand for higher quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Cocaine Use Disorder</condition>
  <condition>Cocaine Dependence</condition>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Soterix Medical mini-CT tDCS stimulator</intervention_name>
    <description>Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation.&#xD;
Stimulation will last 20 minutes per day, three days per week, for 5 weeks</description>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-5 diagnosis of cocaine use disorder&#xD;
&#xD;
          -  Ability to understand the risks/benefits of the study, provide informed consent and&#xD;
             perform tasks as per protocol&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  For females of childbearing capacity, current use of a medically acceptable form of&#xD;
             birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past history of a major neurological disorder (e.g. mental retardation,&#xD;
             Parkinson's disease, Lewy body disease, Huntington's disease, MS, ALS, stroke,&#xD;
             delirium tremens) or seizures, including those symptoms associated with periods of&#xD;
             cocaine withdrawal or abstinence&#xD;
&#xD;
          -  History of Axis I disorder, other than substance use disorder, that is associated with&#xD;
             psychotic symptoms (e.g. schizophrenia) or neurodevelopmental disorder (e.g., autism)&#xD;
&#xD;
          -  Use of medications (current or in the past 6 months) with known CNS effects or which&#xD;
             may alter cerebral function, except psychotropics for depression/anxiety/PTSD (e.g.&#xD;
             SSRIs)&#xD;
&#xD;
          -  Clinically significant unstable medical illness or infection (e.g. HIV, hepatitis,&#xD;
             etc.)&#xD;
&#xD;
          -  Presence of contraindicated metallic implants or devices which may be impacted by&#xD;
             electrical stimulation (e.g. cardiac pacemaker/defibrillator, medication pump,&#xD;
             cochlear implant, implanted brain stimulator)&#xD;
&#xD;
          -  Head trauma with loss of consciousness for more than 30 minutes&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abhishek Datta, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soterix Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>NARC Program</last_name>
      <phone>855-795-4837</phone>
      <email>narc@mssm.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jaimie Gowatsky, MA</last_name>
      <email>jaimie.gowatsky@mssm.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Rita Z Goldstein, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nelly Alia-Klein, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Muhammad A Parvaz, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://soterixmedical.com/</url>
    <description>Soterix Medical</description>
  </link>
  <link>
    <url>https://icahn.mssm.edu/research/narc</url>
    <description>Neuropsychoimaging of Addiction and Related Conditions (NARC) Research Program, Icahn School of Medicine at Mount Sinai</description>
  </link>
  <reference>
    <citation>Batista EK, Klauss J, Fregni F, Nitsche MA, Nakamura-Palacios EM. A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. Int J Neuropsychopharmacol. 2015 Jun 10;18(12):pyv066. doi: 10.1093/ijnp/pyv066.</citation>
    <PMID>26065432</PMID>
  </reference>
  <reference>
    <citation>Agarwal S, Pawlak N, Cucca A, Sharma K, Dobbs B, Shaw M, Charvet L, Biagioni M. Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson's disease: An open-label study. J Clin Neurosci. 2018 Nov;57:51-57. doi: 10.1016/j.jocn.2018.08.037. Epub 2018 Sep 5.</citation>
    <PMID>30193898</PMID>
  </reference>
  <reference>
    <citation>Charvet LE, Dobbs B, Shaw MT, Bikson M, Datta A, Krupp LB. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. Mult Scler. 2018 Nov;24(13):1760-1769. doi: 10.1177/1352458517732842. Epub 2017 Sep 22.</citation>
    <PMID>28937310</PMID>
  </reference>
  <reference>
    <citation>Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583. Epub 2017 Feb 22.</citation>
    <PMID>28225155</PMID>
  </reference>
  <reference>
    <citation>Moeller SJ, Zilverstand A, Konova AB, Kundu P, Parvaz MA, Preston-Campbell R, Bachi K, Alia-Klein N, Goldstein RZ. Neural Correlates of Drug-Biased Choice in Currently Using and Abstinent Individuals With Cocaine Use Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 May;3(5):485-494. doi: 10.1016/j.bpsc.2017.11.001. Epub 2017 Nov 11.</citation>
    <PMID>29735157</PMID>
  </reference>
  <reference>
    <citation>Parvaz MA, Moeller SJ, Malaker P, Sinha R, Alia-Klein N, Goldstein RZ. Abstinence reverses EEG-indexed attention bias between drug-related and pleasant stimuli in cocaine-addicted individuals. J Psychiatry Neurosci. 2016 Jul 19;41(5):150358. doi: 10.1503/jpn.150358. Online ahead of print.</citation>
    <PMID>27434467</PMID>
  </reference>
  <reference>
    <citation>Parvaz MA, Moeller SJ, Goldstein RZ. Incubation of Cue-Induced Craving in Adults Addicted to Cocaine Measured by Electroencephalography. JAMA Psychiatry. 2016 Nov 1;73(11):1127-1134. doi: 10.1001/jamapsychiatry.2016.2181.</citation>
    <PMID>27603142</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <keyword>tDCS</keyword>
  <keyword>Brain Stimulation</keyword>
  <keyword>Cocaine Addiction</keyword>
  <keyword>Drug Craving</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03833583
org study id: SMIN2712-P1
secondary id: HS# 18-01324, GCO# 18-1920
nct id: NCT03833583
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in
      which low level electrical currents are applied to the scalp in order to alter brain
      function. In the present study, tDCS will be administered with the goal of assessing the
      tolerability and feasibility of this approach to 1) reduce an individual's level of drug
      craving and 2) provide evidence to support the use of this device by the patient for future
      unsupervised stimulation in a non-clinical setting.

      Research Questions:

        -  Can tDCS be used successfully to train cocaine addicted individuals for
           self-administration purposes?

        -  Can active tDCS be used to decrease drug craving in individuals with cocaine use
           disorders?

        -  Does active tDCS outperform sham tDCS in reducing drug craving?
The ultimate goal of this project is to develop a portable neuromodulatory intervention to
      reduce craving in cocaine addiction. This proposed project is in response to NIH/NIDA's
      solicitation titled "Development of Portable Neuromodulatory Device for the Treatment of
      Substance Use Disorders (SUDs)." The present study aims to evaluate the tolerability and
      feasibility of repeated administration of tDCS to reduce drug craving in individuals with
      cocaine addiction, with the aim of using these data to support a phase II study and,
      ultimately, support of approval of usage of this device without clinical supervision.

      The specific objectives are:

        1. Establish the feasibility and safety of using tDCS to reduce self-reported cravings in
           individuals addicted to cocaine.

        2. Train cocaine addicted individuals to self-administer tDCS (under supervision) to test
           the feasibility of future home self-administration in this population.

      Substance use disorders present a treatment challenge for clinicians, as well as a
      socioeconomic burden on individuals and society at large. Cocaine use disorder occurs when
      someone experiences clinically significant impairment caused by the recurrent use of cocaine,
      including health problems, physical withdrawal with discontinuation of use,
      persistent/escalating use, and failure to meet major personal, occupational, or educational
      responsibilities. At present, no FDA approved medicines are available to treat cocaine
      dependence, and behavioral therapy may be used to treat this addiction, though with limited
      efficacy. Drug craving (strong obsessions about and/or irresistible urges or compulsions to
      consume a drug) is a central driving force for perpetuation of substance use and subsequent
      addiction, as well as relapse after abstinence. Currently, no treatments exist that are
      targeted at reducing drug craving, which is intrusive and distressing to patients. The
      prefrontal cortex (PFC) plays an important role inhibiting these intrusive cravings. However,
      decades of data have shown that PFC activity is impaired in addictions. In this study, our
      goal is to increase PFC activity with non-invasive neuromodulation. Given the role of the PFC
      in the processing and regulation of craving behavior, this brain region is a key target for
      brain stimulation.

      This study will recruit individuals with a diagnosis of cocaine use disorder (per DSM-5
      criteria) who are receiving treatment for their substance use disorder at Samaritan Daytop
      Village (SDV) and other similar treatment facilities (e.g., Phoenix House, Mount Sinai's
      network of hospitals and clinics). Patients will be randomly assigned to receive either
      active or sham (placebo) tDCS. Participants will receive 20 minutes of stimulation per tDCS
      day, three days per week for five weeks.

      Interviews and neuropsychological testing will be conducted, and self-reported drug craving
      and addiction severity questionnaires will be used. Follow up cognitive and behavioral
      assessments will be conducted over a period of 12 months post tDCS stimulation. In addition,
      participants will be asked to perform EEG, cognitive tasks, and collection of a blood sample
      to assess genetic/epigenetic patterns.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)
description: Craving for cocaine will be assessed with a brief scale composed of 5 items (1, 2, 4, 5, and 13) from the Obsessive-Compulsive Cocaine Scale (OCCS; Vorspan et al., 2012).
measure: Change in Depression symptoms from Baseline (Ham-D score)
time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)
description: Depression symptoms will be assessed by the Hamilton Rating Scale for Depression (24 item version, HAM-D; Hamilton, 1960).
measure: Change in Anxiety symptoms from Baseline (HAM-A score)
time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)
description: Anxiety symptoms will be assessed by the Hamilton Rating Scale for Anxiety (HAM-A; Hamilton, 1959).
measure: Change in Quality of Life from Baseline (WHOQOL-BREF score)
time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (every three months for up to 1 year)
description: An abbreviated instrument of cross-culturally valid assessment of quality of life of the World Health Organization (WHOQOL-BREF) with 26 questions (WHOQOL Group, 1998; Skevington et al., 2004) yields 4 domains (physical health, psychological, social relationships, and environment) and 2 individually scored items regarding overall perception of quality of life (Q1) and health (Q2). The 4 domain scores are scaled in a way that higher scores stand for higher quality of life.
arm group label: Active tDCS
arm group type: Experimental
description: Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
intervention type: Device
intervention name: Soterix Medical mini-CT tDCS stimulator
description: Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation.
Stimulation will last 20 minutes per day, three days per week, for 5 weeks
arm group label: Active tDCS
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Abhishek Datta, PhD
role: Principal Investigator
affiliation: Soterix Medical
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
url: https://soterixmedical.com/
description: Soterix Medical
url: https://icahn.mssm.edu/research/narc
description: Neuropsychoimaging of Addiction and Related Conditions (NARC) Research Program, Icahn School of Medicine at Mount Sinai
citation: Batista EK, Klauss J, Fregni F, Nitsche MA, Nakamura-Palacios EM. A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. Int J Neuropsychopharmacol. 2015 Jun 10;18(12):pyv066. doi: 10.1093/ijnp/pyv066.
PMID: 26065432
citation: Agarwal S, Pawlak N, Cucca A, Sharma K, Dobbs B, Shaw M, Charvet L, Biagioni M. Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson's disease: An open-label study. J Clin Neurosci. 2018 Nov;57:51-57. doi: 10.1016/j.jocn.2018.08.037. Epub 2018 Sep 5.
PMID: 30193898
citation: Charvet LE, Dobbs B, Shaw MT, Bikson M, Datta A, Krupp LB. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. Mult Scler. 2018 Nov;24(13):1760-1769. doi: 10.1177/1352458517732842. Epub 2017 Sep 22.
PMID: 28937310
citation: Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583. Epub 2017 Feb 22.
PMID: 28225155
citation: Moeller SJ, Zilverstand A, Konova AB, Kundu P, Parvaz MA, Preston-Campbell R, Bachi K, Alia-Klein N, Goldstein RZ. Neural Correlates of Drug-Biased Choice in Currently Using and Abstinent Individuals With Cocaine Use Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 May;3(5):485-494. doi: 10.1016/j.bpsc.2017.11.001. Epub 2017 Nov 11.
PMID: 29735157
citation: Parvaz MA, Moeller SJ, Malaker P, Sinha R, Alia-Klein N, Goldstein RZ. Abstinence reverses EEG-indexed attention bias between drug-related and pleasant stimuli in cocaine-addicted individuals. J Psychiatry Neurosci. 2016 Jul 19;41(5):150358. doi: 10.1503/jpn.150358. Online ahead of print.
PMID: 27434467
citation: Parvaz MA, Moeller SJ, Goldstein RZ. Incubation of Cue-Induced Craving in Adults Addicted to Cocaine Measured by Electroencephalography. JAMA Psychiatry. 2016 Nov 1;73(11):1127-1134. doi: 10.1001/jamapsychiatry.2016.2181.
PMID: 27603142
responsible party type: Sponsor
mesh term: Cocaine-Related Disorders
mesh term: Behavior, Addictive
sharing ipd: No