<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/NCT02994875</url>
  </required_header>
  <id_info>
    <org_study_id>1510016617</org_study_id>
    <secondary_id>1K01DA039299-01A1</secondary_id>
    <nct_id>NCT02994875</nct_id>
  </id_info>
  <brief_title>Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence</brief_title>
  <official_title>Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</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>Yale University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this research is to identify the functional neural mechanisms (as assessed&#xD;
      using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained&#xD;
      individuals with cocaine dependence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this research is to identify the functional neural mechanisms (as assessed&#xD;
      using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained&#xD;
      individuals with cocaine dependence. Specifically, this application proposes to conduct a&#xD;
      randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects&#xD;
      of 7-day NAC administration (2400mg/day) on the neural networks engaged during response&#xD;
      inhibition (Go/No-Go task) and affective (emotion-regulation task) processes among&#xD;
      cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">September 2020</completion_date>
  <primary_completion_date type="Actual">September 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in neural network engagement measured using functional magnetic resonance imaging</measure>
    <time_frame>4 weeks</time_frame>
    <description>The primary outcome measure for this study is change (NAC versus placebo) in neural network engagement during fMRI task performance.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cocaine Dependence</condition>
  <arm_group>
    <arm_group_label>Placebo First</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo - Participants will receive placebo for one week. Following a two-week washout period, they will receive NAC for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAC First</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>N-acetylcysteine - Participants will receive NAC for one week. Following a two-week washout period, they will receive placebo for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>N-acetylcysteine</intervention_name>
    <description>NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.</description>
    <arm_group_label>NAC First</arm_group_label>
    <other_name>NAC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sugar pill</description>
    <arm_group_label>Placebo First</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. enrollment in the APT methadone program and maintained on a stable dose of methadone&#xD;
             for ≥ 2 weeks&#xD;
&#xD;
          2. males or females, aged 18-65&#xD;
&#xD;
          3. confirmed DSM-IV diagnosis of current cocaine use disorder as assessed at the&#xD;
             screening assessment&#xD;
&#xD;
          4. for women of a child-bearing age, acceptable birth control method&#xD;
&#xD;
          5. ability to commit to 4 weeks of study participation plus 1-month follow-up&#xD;
&#xD;
          6. willingness to be randomized to NAC or placebo&#xD;
&#xD;
          7. eligibility for MRI scanning and willingness to participate in MRI scanning.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Do not meet DSM-IV criteria for cocaine-use disorder.&#xD;
&#xD;
          2. Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar&#xD;
             disorder, or exhibit significant current suicidal or homicidal plans and intent such&#xD;
             that hospitalization is required.&#xD;
&#xD;
          3. Meet DSM-IV criteria for current alcohol or other substance-use disorder dependence&#xD;
             (with the exceptions of nicotine, cocaine and opioids).&#xD;
&#xD;
          4. Have previously taken or currently take NAC.&#xD;
&#xD;
          5. Have asthma (due to possible complications with NAC).&#xD;
&#xD;
          6. Cannot commit to 4-weeks of study participation or are unwilling to accept&#xD;
             randomization.&#xD;
&#xD;
          7. Have any contraindications for MRI scanning (e.g., pregnancy, color-blindness,&#xD;
             claustrophobia, metal implants that could interfere with MRI, any other&#xD;
             contraindication to scanning).&#xD;
&#xD;
          8. Have lab work (complete blood count, urinalysis, liver function tests, thyroid&#xD;
             function tests) suggesting the presence of any abnormalities or have a significant or&#xD;
             unstable medical illness.&#xD;
&#xD;
          9. Are women who are pregnant or of a child-bearing age who do not agree to adequate&#xD;
             contraception to prevent pregnancy during the study period.&#xD;
&#xD;
         10. Are not fluent in English.&#xD;
&#xD;
         11. Do not have at least a 6th grade reading level.&#xD;
&#xD;
         12. Cannot provide written, informed consent.&#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>Sarah Yip, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02994875
org study id: 1510016617
secondary id: 1K01DA039299-01A1
nct id: NCT02994875
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The objective of this research is to identify the functional neural mechanisms (as assessed
      using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained
      individuals with cocaine dependence.
The objective of this research is to identify the functional neural mechanisms (as assessed
      using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained
      individuals with cocaine dependence. Specifically, this application proposes to conduct a
      randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects
      of 7-day NAC administration (2400mg/day) on the neural networks engaged during response
      inhibition (Go/No-Go task) and affective (emotion-regulation task) processes among
      cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in neural network engagement measured using functional magnetic resonance imaging
time frame: 4 weeks
description: The primary outcome measure for this study is change (NAC versus placebo) in neural network engagement during fMRI task performance.
arm group label: Placebo First
arm group type: Placebo Comparator
description: Placebo - Participants will receive placebo for one week. Following a two-week washout period, they will receive NAC for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications
arm group label: NAC First
arm group type: Active Comparator
description: N-acetylcysteine - Participants will receive NAC for one week. Following a two-week washout period, they will receive placebo for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications
intervention type: Dietary Supplement
intervention name: N-acetylcysteine
description: NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.
arm group label: NAC First
other name: NAC
intervention type: Other
intervention name: Placebo
description: Sugar pill
arm group label: Placebo First
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sarah Yip, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cocaine-Related Disorders
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine
sharing ipd: Undecided