<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/NCT03276221</url>
  </required_header>
  <id_info>
    <org_study_id>1K23DA042946</org_study_id>
    <nct_id>NCT03276221</nct_id>
  </id_info>
  <brief_title>Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents</brief_title>
  <official_title>Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use a randomized controlled design to test whether 30 days of cannabis&#xD;
      abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive&#xD;
      functioning. Non-using controls will also be enrolled to determine the clinical significance&#xD;
      of any cognitive improvements with abstinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 5-year randomized, longitudinal trial of cannabis abstinence designed to determine&#xD;
      (1) if performance improves with abstinence beyond that observed with continued cannabis use,&#xD;
      and if so, (2) when during abstinence cognitive improvement occurs, and (3) whether&#xD;
      performance in abstinent individuals &quot;returns&quot; to performance levels observed in non-using&#xD;
      peers. We hypothesized that abstinent adolescent cannabis users would have more&#xD;
      neurocognitive improvement over four weeks compared to non-abstinent cannabis users, and&#xD;
      performance would continuously improve throughout four weeks of abstinence. We will recruit&#xD;
      210 adolescents with and without regular cannabis use. Eligible cannabis users will be&#xD;
      randomized to either a contingency management intervention which will incentivize 4 weeks of&#xD;
      cannabis abstinence (n = 70), or non-contingent monitoring with no abstinence requirement (n&#xD;
      = 70). All participants (including non-users; n = 70) will complete cognitive assessments,&#xD;
      toxicology testing, self-report questionnaires and semi-structured mood and substance use&#xD;
      interviews during the 4-week study as well as one 30-day follow-up visit. Abstinence will be&#xD;
      indexed by decreasing levels of cannabis metabolites in urine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">November 9, 2022</completion_date>
  <primary_completion_date type="Actual">November 9, 2022</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>Cannabis users are randomized either to 30 days of cannabis abstinence or 30 days of monitoring with no abstinence requirement. Non-users are not randomized.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Memory Measured with the CANTAB</measure>
    <time_frame>From Baseline to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Attention Measured with the CANTAB</measure>
    <time_frame>From Baseline to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Executive Functioning Measured with the CANTAB</measure>
    <time_frame>From Baseline to 30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Cannabis Use</condition>
  <condition>Cognitive Change</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Abstinent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of cannabis users are agree to remain abstinent from cannabis use for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monitoring</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of cannabis users are not asked to change their cannabis use behavior.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Users</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is a group of adolescents with little to no cannabis use history and is non-randomized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Abstinence</intervention_name>
    <description>Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.</description>
    <arm_group_label>Abstinent</arm_group_label>
    <other_name>Contingency Management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria:&#xD;
&#xD;
          -  Male and female adolescents from the Boston area who are between the ages of 13 and 19&#xD;
             (inclusive);&#xD;
&#xD;
          -  Have a parent or legal guardian who is able and willing to provide written informed&#xD;
             consent for the active study phase (if under the age of 18);&#xD;
&#xD;
          -  Competent and willing to provide written informed assent for the active study phase&#xD;
             (if under the age of 18);&#xD;
&#xD;
          -  Competent and able to provide written informed consent (if age 18 or older)&#xD;
&#xD;
          -  Able to communicate in English language&#xD;
&#xD;
          -  Able to commit to 9 study visits in approximately 60 days&#xD;
&#xD;
        Cannabis-Using Group Inclusion Criteria:&#xD;
&#xD;
          -  Use of cannabis at least once per week on most weeks&#xD;
&#xD;
          -  Cannabis use reported within 7 days of both baseline visits&#xD;
&#xD;
        Non-Using Group Inclusion Criteria:&#xD;
&#xD;
        - Use of cannabis less than 5 times in lifetime&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          -  In the opinion of the investigator, not able to safely participate in this study&#xD;
             because of any medical or psychological issues (e.g. psychosis) that might compromise&#xD;
             their safety.&#xD;
&#xD;
        Non-Using Group Exclusion Criteria:&#xD;
&#xD;
          -  No cannabis use in the past year&#xD;
&#xD;
          -  No cannabis use before age 16&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Randi M Schuster, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Randi Melissa Schuster</investigator_full_name>
    <investigator_title>Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <!-- 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/NCT03276221
org study id: 1K23DA042946
nct id: NCT03276221
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will use a randomized controlled design to test whether 30 days of cannabis
      abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive
      functioning. Non-using controls will also be enrolled to determine the clinical significance
      of any cognitive improvements with abstinence.
This is a 5-year randomized, longitudinal trial of cannabis abstinence designed to determine
      (1) if performance improves with abstinence beyond that observed with continued cannabis use,
      and if so, (2) when during abstinence cognitive improvement occurs, and (3) whether
      performance in abstinent individuals "returns" to performance levels observed in non-using
      peers. We hypothesized that abstinent adolescent cannabis users would have more
      neurocognitive improvement over four weeks compared to non-abstinent cannabis users, and
      performance would continuously improve throughout four weeks of abstinence. We will recruit
      210 adolescents with and without regular cannabis use. Eligible cannabis users will be
      randomized to either a contingency management intervention which will incentivize 4 weeks of
      cannabis abstinence (n = 70), or non-contingent monitoring with no abstinence requirement (n
      = 70). All participants (including non-users; n = 70) will complete cognitive assessments,
      toxicology testing, self-report questionnaires and semi-structured mood and substance use
      interviews during the 4-week study as well as one 30-day follow-up visit. Abstinence will be
      indexed by decreasing levels of cannabis metabolites in urine.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cannabis users are randomized either to 30 days of cannabis abstinence or 30 days of monitoring with no abstinence requirement. Non-users are not randomized.
primary purpose: Other
masking: None (Open Label)
measure: Change in Memory Measured with the CANTAB
time frame: From Baseline to 30 days
measure: Change in Attention Measured with the CANTAB
time frame: From Baseline to 30 days
measure: Change in Executive Functioning Measured with the CANTAB
time frame: From Baseline to 30 days
arm group label: Abstinent
arm group type: Active Comparator
description: This group of cannabis users are agree to remain abstinent from cannabis use for 30 days.
arm group label: Monitoring
arm group type: No Intervention
description: This group of cannabis users are not asked to change their cannabis use behavior.
arm group label: Non-Users
arm group type: No Intervention
description: This is a group of adolescents with little to no cannabis use history and is non-randomized.
intervention type: Behavioral
intervention name: Abstinence
description: Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.
arm group label: Abstinent
other name: Contingency Management
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Randi M Schuster, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Randi Melissa Schuster
investigator title: Fellow
mesh term: Marijuana Abuse