<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/NCT03786224</url>
  </required_header>
  <id_info>
    <org_study_id>2018P001848</org_study_id>
    <nct_id>NCT03786224</nct_id>
  </id_info>
  <brief_title>Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence</brief_title>
  <official_title>Pilot Trial on the Efficacy of Contingency Management for Six Months of Cannabis Abstinence Among 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 is a critically important first-of-its-kind investigation of the potential&#xD;
      research utility of using contingency management to examine long-term changes in cannabis use&#xD;
      with six months of abstinence. These pilot data will inform a later trial which will focus on&#xD;
      testing the longitudinal relationships between adolescent cognition and cannabis use,&#xD;
      questions of high and growing public health significance given adolescents' increased access&#xD;
      to cannabis with legalization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Continuous abstinence via progressive declines in urine THCCOOH</measure>
    <time_frame>Six months</time_frame>
    <description>Cannabis abstinence will be indexed by progressively decreasing quantitative levels of 11-nor-delta-9-THC-9-carboxylic acid (THCCOOH), the primary cannabis metabolite, in urine. Residual cannabinoid excretion will be differentiated from new cannabis exposure using a statistical model developed by Schwilke and colleagues (2011). This model was empirically derived from urine CN-THCCOOH concentration ratios of consecutively collected specimen pairs (current specimen/prior specimen). This model takes into account the time between collection of specimens, which enhances the accuracy of prediction of new cannabis use. This formula yields an expected CN-THCCOOH ratio associated with specimen pairs during abstinence, and observed ratios that exceed this expected value are interpreted as new cannabis use.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cannabis Use</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Abstinent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Contingency Management</intervention_name>
    <description>Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.</description>
    <arm_group_label>Abstinent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female adolescents actively enrolled in a middle or high school in the Boston&#xD;
             area who are between the ages of 13 and 19 (inclusive);&#xD;
&#xD;
          -  Average use of cannabis at least 3 times per week during the 3 months prior to study&#xD;
             enrollment;&#xD;
&#xD;
          -  Cannabis use reported within 7 days of study enrollment;&#xD;
&#xD;
          -  No immediate plan to discontinue cannabis use;&#xD;
&#xD;
          -  Have a parent or legal guardian who is competent and willing to provide written&#xD;
             informed 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 willing to provide written informed consent (if age 18 or older);&#xD;
&#xD;
          -  Able to communicate in English language;&#xD;
&#xD;
          -  Have a parent/guardian who can communicate in English language;&#xD;
&#xD;
          -  Able to commit to 27 study visits in approximately 6 months;&#xD;
&#xD;
          -  Able to safely participate in the protocol and appropriate for outpatient level of&#xD;
             care, in the opinion of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Any severe developmental delays (including, but not limited to, Autism Spectrum Disorder,&#xD;
        Intellectual Disability, and Down Syndrome).&#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>
  <overall_contact>
    <last_name>Randi M Schuster, PhD</last_name>
    <phone>617-643-6673</phone>
    <email>Rschuster@mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Randi M Schuster, PhD</last_name>
      <phone>617-643-6673</phone>
      <email>Rschuster@mgh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Randi M Schuster, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</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>Assistant Professor</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/NCT03786224
org study id: 2018P001848
nct id: NCT03786224
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a critically important first-of-its-kind investigation of the potential
      research utility of using contingency management to examine long-term changes in cannabis use
      with six months of abstinence. These pilot data will inform a later trial which will focus on
      testing the longitudinal relationships between adolescent cognition and cannabis use,
      questions of high and growing public health significance given adolescents' increased access
      to cannabis with legalization.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Continuous abstinence via progressive declines in urine THCCOOH
time frame: Six months
description: Cannabis abstinence will be indexed by progressively decreasing quantitative levels of 11-nor-delta-9-THC-9-carboxylic acid (THCCOOH), the primary cannabis metabolite, in urine. Residual cannabinoid excretion will be differentiated from new cannabis exposure using a statistical model developed by Schwilke and colleagues (2011). This model was empirically derived from urine CN-THCCOOH concentration ratios of consecutively collected specimen pairs (current specimen/prior specimen). This model takes into account the time between collection of specimens, which enhances the accuracy of prediction of new cannabis use. This formula yields an expected CN-THCCOOH ratio associated with specimen pairs during abstinence, and observed ratios that exceed this expected value are interpreted as new cannabis use.
arm group label: Abstinent
arm group type: Experimental
intervention type: Behavioral
intervention name: Contingency Management
description: Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.
arm group label: Abstinent
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
last name: Randi M Schuster, PhD
phone: 617-643-6673
email: Rschuster@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Randi Melissa Schuster
investigator title: Assistant Professor
mesh term: Marijuana Abuse