xml: <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/NCT05978167</url>
    </required_header>
    <id_info>
      <org_study_id>GCO 20-2707</org_study_id>
      <secondary_id>R21DA054281</secondary_id>
      <nct_id>NCT05978167</nct_id>
    </id_info>
    <brief_title>Targeting Drug Memories With Methylphenidate</brief_title>
    <official_title>Targeting Neural, Behavioral and Pharmacological Mechanisms of Drug Memories in Drug Addiction With Methylphenidate</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</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>
        This study aims to identify the neural, behavioral, and pharmacological mechanisms promoting&#xD;
        diminished expression of drug-related memories in human drug addiction. In this fMRI study&#xD;
        with a within-subjects placebo-controlled double-blind cross-over design, oral&#xD;
        methylphenidate (20 mg) or placebo will be administered to individuals with cocaine use&#xD;
        disorders (CUD) to peak during the retrieval of a drug-cue memory before extinction; in&#xD;
        addition to fMRI activations, skin conductance responses (SCR, acquired simultaneously) will&#xD;
        serve as the psychophysiological indicators of memory modification. Assessments of&#xD;
        interference with the return of drug-cue memories via SCR and craving will be conducted the&#xD;
        day following MRI. This pharmocologically-enhanced behavioral approach to decreasing drug&#xD;
        memories and craving in iCUD could ultimately be used to develop effective cue-exposure&#xD;
        therapies for drug addiction. Procedures include MRI, blood draw, questionnaires and&#xD;
        interviews, skin conductance response measures, and behavioral tasks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cue-exposure therapy has not proven efficacious in reducing relapse in drug addiction,&#xD;
        illuminating the need for alternative strategies. Here researchers will test the neural&#xD;
        correlates of two strategies, encompassing behavioral and pharmacological approaches, aimed&#xD;
        to interfere with the return of drug memories in individuals with cocaine use disorders.&#xD;
        Results may pave the way towards enhancing the efficacy of cue-exposure therapy in reducing&#xD;
        cue-induced craving and relapse in drug addiction (generalizable across drugs of&#xD;
        abuse/behavioral addictions).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>fMRI blood-oxygenation level dependent (BOLD) signal</measure>
      <time_frame>Day 1</time_frame>
      <description>fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>fMRI blood-oxygenation level dependent (BOLD) signal</measure>
      <time_frame>Day 7</time_frame>
      <description>fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Skin Conductance Responses (SCR)</measure>
      <time_frame>24 hours after each neuroimaging session</time_frame>
      <description>Measure of changes to skin conductance responses in response to retrieval of drug-cue memory. The conductance is measured by placing two electrodes on the fingers and passing a small, 0.5 V electric charge between the two points. An increase in the skin conductance response (SCR) reflects heightened arousal in response to the drug-cue memory, changes in which are monitored following exposure to the drug cues.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Craving</measure>
      <time_frame>24 hours after each neuroimaging session</time_frame>
      <description>Measure of changes to craving in response to retrieval of drug-cue memory. Self-reported cue-induced craving in response to drug cues will be assessed.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Substance Use Disorder</condition>
    <condition>Cocaine Use Disorder</condition>
    <arm_group>
      <arm_group_label>Methylphenidate then Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>20 mg of methylphenidate then matching placebo pill.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo then Methylphenidate</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Matching placebo pill then 20 mg of methylphenidate.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Methylphenidate</intervention_name>
      <description>Oral administration of 20 mg Methylphenidate</description>
      <arm_group_label>Methylphenidate then Placebo</arm_group_label>
      <arm_group_label>Placebo then Methylphenidate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Memory reconsolidation</intervention_name>
      <description>Retrieval of drug-cue memories before extinction.</description>
      <arm_group_label>Methylphenidate then Placebo</arm_group_label>
      <arm_group_label>Placebo then Methylphenidate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching placebo pill</description>
      <arm_group_label>Methylphenidate then Placebo</arm_group_label>
      <arm_group_label>Placebo then Methylphenidate</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Ability to understand and give informed consent&#xD;
  &#xD;
            -  Males and females 26-50 years of age&#xD;
  &#xD;
            -  DSM-V diagnosis for CUD or otherwise problematic cocaine use as clinically determined&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  DSM-5 diagnosis for schizophrenia or developmental disorder (e.g., autism)&#xD;
  &#xD;
            -  Head trauma with loss of consciousness&#xD;
  &#xD;
            -  History of neurological disease of central origin including seizures&#xD;
  &#xD;
            -  Cardiovascular disease including high blood pressure and/or other medical conditions,&#xD;
               including metabolic, endocrinological, oncological or autoimmune diseases, and&#xD;
               infectious diseases including Hepatitis B and C or HIV/AIDS&#xD;
  &#xD;
            -  Metal implants or other MR contraindications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>26 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rita Z Goldstein, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Natalie E McClain, BA</last_name>
      <phone>5023034101</phone>
      <email>natalie.mcclain@mssm.edu</email>
    </overall_contact>
    <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>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 18, 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Rita Goldstein</investigator_full_name>
      <investigator_title>Chief of Research</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methylphenidate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to rita.goldstein@mssm.edu. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978167
  org study id: GCO 20-2707
  secondary id: R21DA054281
  nct id: NCT05978167
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study aims to identify the neural, behavioral, and pharmacological mechanisms promoting
        diminished expression of drug-related memories in human drug addiction. In this fMRI study
        with a within-subjects placebo-controlled double-blind cross-over design, oral
        methylphenidate (20 mg) or placebo will be administered to individuals with cocaine use
        disorders (CUD) to peak during the retrieval of a drug-cue memory before extinction; in
        addition to fMRI activations, skin conductance responses (SCR, acquired simultaneously) will
        serve as the psychophysiological indicators of memory modification. Assessments of
        interference with the return of drug-cue memories via SCR and craving will be conducted the
        day following MRI. This pharmocologically-enhanced behavioral approach to decreasing drug
        memories and craving in iCUD could ultimately be used to develop effective cue-exposure
        therapies for drug addiction. Procedures include MRI, blood draw, questionnaires and
        interviews, skin conductance response measures, and behavioral tasks.
  Cue-exposure therapy has not proven efficacious in reducing relapse in drug addiction,
        illuminating the need for alternative strategies. Here researchers will test the neural
        correlates of two strategies, encompassing behavioral and pharmacological approaches, aimed
        to interfere with the return of drug memories in individuals with cocaine use disorders.
        Results may pave the way towards enhancing the efficacy of cue-exposure therapy in reducing
        cue-induced craving and relapse in drug addiction (generalizable across drugs of
        abuse/behavioral addictions).
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: fMRI blood-oxygenation level dependent (BOLD) signal
  time frame: Day 1
  description: fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.
  measure: fMRI blood-oxygenation level dependent (BOLD) signal
  time frame: Day 7
  description: fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.
  measure: Skin Conductance Responses (SCR)
  time frame: 24 hours after each neuroimaging session
  description: Measure of changes to skin conductance responses in response to retrieval of drug-cue memory. The conductance is measured by placing two electrodes on the fingers and passing a small, 0.5 V electric charge between the two points. An increase in the skin conductance response (SCR) reflects heightened arousal in response to the drug-cue memory, changes in which are monitored following exposure to the drug cues.
  measure: Craving
  time frame: 24 hours after each neuroimaging session
  description: Measure of changes to craving in response to retrieval of drug-cue memory. Self-reported cue-induced craving in response to drug cues will be assessed.
  arm group label: Methylphenidate then Placebo
  arm group type: Experimental
  description: 20 mg of methylphenidate then matching placebo pill.
  arm group label: Placebo then Methylphenidate
  arm group type: Placebo Comparator
  description: Matching placebo pill then 20 mg of methylphenidate.
  intervention type: Drug
  intervention name: Methylphenidate
  description: Oral administration of 20 mg Methylphenidate
  arm group label: Methylphenidate then Placebo
  arm group label: Placebo then Methylphenidate
  intervention type: Behavioral
  intervention name: Memory reconsolidation
  description: Retrieval of drug-cue memories before extinction.
  arm group label: Methylphenidate then Placebo
  arm group label: Placebo then Methylphenidate
  intervention type: Drug
  intervention name: Placebo
  description: Matching placebo pill
  arm group label: Methylphenidate then Placebo
  arm group label: Placebo then Methylphenidate
  criteria: 
  gender: All
  minimum age: 26 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Rita Z Goldstein, PhD
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Natalie E McClain, BA
  phone: 5023034101
  email: natalie.mcclain@mssm.edu
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Rita Goldstein
  investigator title: Chief of Research
  mesh term: Substance-Related Disorders
  mesh term: Methylphenidate
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
  ipd info type: Study Protocol
  ipd time frame: Immediately following publication. No end date.
  ipd access criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to rita.goldstein@mssm.edu. To gain access, data requestors will need to sign a data access agreement.