<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/NCT03274440</url>
  </required_header>
  <id_info>
    <org_study_id># 7405</org_study_id>
    <nct_id>NCT03274440</nct_id>
  </id_info>
  <brief_title>Effects of Marijuana on Symptoms of OCD</brief_title>
  <acronym>ECOS</acronym>
  <official_title>Effects of Marijuana on Symptoms of Obsessive-Compulsive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot research study is to test whether certain components of the&#xD;
      marijuana plant, known as &quot;cannabinoids&quot;, may help to reduce symptoms in patients with OCD.&#xD;
      Specifically, patients enrolled in the study will smoke marijuana containing different&#xD;
      concentrations of 2 different cannabinoids, THC and CBD. Both of these agents act on the&#xD;
      brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD. Neither&#xD;
      compound is currently FDA-approved for treating OCD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior research suggests that certain areas of the brain are receptive to chemicals like those&#xD;
      found in the cannabis (marijuana) plant, known as cannabinoids, and that these regions may be&#xD;
      involved in anxiety disorders and OCD. More recent data shows that synthetic drugs that&#xD;
      target these systems may be helpful in conditions related to OCD like anxiety disorders and&#xD;
      Tourette's syndrome. Thus, these substances could also possibly be useful to treat OCD&#xD;
      symptoms. However, to date there has been little research regarding the role of cannabinoids&#xD;
      in OCD.&#xD;
&#xD;
      The purpose of this study is to examine the effects of different cannabinoids on OCD symptoms&#xD;
      in humans. To accomplish this in a laboratory setting, patients with OCD who are also&#xD;
      occasional cannabis users will receive different combinations of two of the most well-studied&#xD;
      cannabinoids, delta-9-tetrahydrocannabinol (THC, the main psychoactive component in cannabis)&#xD;
      and cannabidiol (CBD, another component of the cannabis plant). We will then measure acute&#xD;
      effects on OCD symptoms, anxiety, intoxication, and cardiovascular outcomes (i.e. blood&#xD;
      pressure and heart rate).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 29, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)</measure>
    <time_frame>Baseline was obtained at the beginning of each session. Then, change from baseline was measured following cannabis administration (minute 0) at minutes 20, 40, 60, 90, 120, and 180. This procedure was repeated for each of the 3 conditions.</time_frame>
    <description>An adapted version of the Yale-Brown Obsessive-Compulsive Scale (YBOCS) which measures change in OCD symptoms over short time frames (i.e., since the last assessment as opposed to over the past week). Total score is reported. Scores range from 0 (no symptoms) to 40 (severe symptoms).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spielberger State-Trait Anxiety Scale: State Version (STAI-S)</measure>
    <time_frame>Baseline obtained at the beginning of the session (Minutes 0), and then the scale was obtained at minutes 20, 40, 60, 90, 120, and 180 after cannabis administration.</time_frame>
    <description>A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>High THC/Low CBD Marijuana</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (&lt;1%) content.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low THC/High CBD Marijuana</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This condition involves the ingestion of marijuana with a low THC (&lt;1%) and high CBD (&gt;10%) content.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No THC/No CBD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This condition involves the ingestion of a placebo control with no THC and no CBD content.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabis</intervention_name>
    <description>THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
    <arm_group_label>High THC/Low CBD Marijuana</arm_group_label>
    <arm_group_label>Low THC/High CBD Marijuana</arm_group_label>
    <other_name>marijuana</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo control group, not receiving THC or CBD.</description>
    <arm_group_label>No THC/No CBD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-55&#xD;
&#xD;
          -  Physically healthy&#xD;
&#xD;
          -  Diagnosed with OCD&#xD;
&#xD;
          -  Current marijuana user&#xD;
&#xD;
          -  Women of childbearing potential must be using an effective form of birth control&#xD;
&#xD;
          -  Not currently taking psychotropic medications&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any significant medical condition that may increase the risk of&#xD;
             participation&#xD;
&#xD;
          -  Females who are pregnant or nursing&#xD;
&#xD;
          -  If female, not pregnant&#xD;
&#xD;
          -  Current or lifetime history of psychiatric disorders other than OCD that may increase&#xD;
             the risk of participation&#xD;
&#xD;
          -  Current substance use disorder&#xD;
&#xD;
          -  Severe depression or positive urine toxicology (other than THC) at screening, or any&#xD;
             adverse reaction to a cannabinoid&#xD;
&#xD;
          -  Patients who are seeking treatment for substance abuse&#xD;
&#xD;
          -  Patients who are planning to begin a course of cognitive-behavioral therapy within 8&#xD;
             weeks of beginning the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reilly Kayser, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York State Psychiatric Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>May 15, 2020</results_first_submitted>
  <results_first_submitted_qc>June 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2020</results_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Reilly R. Kayser</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>OCD</keyword>
  <keyword>Marijuana</keyword>
  <keyword>THC</keyword>
  <keyword>Cannabis</keyword>
  <keyword>CBD</keyword>
  <keyword>Cannabinoid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03274440/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were randomized to receive high THC/low CBD cannabis (&quot;THC&quot;), low THC/high CBD cannabis (&quot;CBD&quot;), and placebo cannabis (&quot;PBO&quot;). Total participants for each order were:&#xD;
Order A (THC, CBD, PBO) = 3 Order B (THC, PBO, CBD) = 2 Order C (CBD, THC, PBO) = 4 Order D (CBD, PBO, THC) = 1 Order E (PBO, THC, CBD) = 1 Order F (PBO, CBD, THC) = 3</recruitment_details>
      <pre_assignment_details>Participants who met study criteria and chose to participate were assigned to receive each of the three study conditions (high THC/low CBD; low THC/high CBD; placebo with no THC or CBD) in random order. All sessions were separated by at least 1 calendar week.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Order A</title>
          <description>Order A: THC, CBD, PBO.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
        </group>
        <group group_id="P2">
          <title>Order B</title>
          <description>Order B: THC, PBO, CBD.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
        </group>
        <group group_id="P3">
          <title>Order C</title>
          <description>Order C: CBD, THC, PBO.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
        </group>
        <group group_id="P4">
          <title>Order D</title>
          <description>Order D: CBD, PBO, THC.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
        </group>
        <group group_id="P5">
          <title>Order E</title>
          <description>Order E: PBO, THC, CBD.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
        </group>
        <group group_id="P6">
          <title>Order F</title>
          <description>Order F: PBO, CBD, THC.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Time commitment too great</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics for all study completers</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>In this within-subjects study, all participants received all three study drugs in random order. Demographic data is provided for all study participants together.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.8" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psychiatric Comorbidity</title>
          <description>Comorbid psychiatric conditions (other than OCD)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Major Depressive Disorder (MDD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Generalized Anxiety Disorder (GAD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Panic Disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication Status</title>
          <description>Number of patients taking psychotropic medication</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Selective Serotonin Reuptake Inhibitor (SSRI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unmedicated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cannabis use at time of enrollment</title>
          <description>Self-reported cannabis use (number of days per week) at time of enrollment</description>
          <units>days per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.8" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Yale-Brown Obsessive-Compulsive Scale (YBOCS)</title>
          <description>A scale measuring OCD symptom severity. Total score is reported and ranges from 0 (no symptoms) to 40 (severe symptoms). Scores &gt;16 are consistent with clinical OCD symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.1" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Speilberger State-Trait Anxiety Scale, Trait Version (STAI-T)</title>
          <description>A scale measuring trait anxiety. Total score is reported and ranges from 20 (no trait anxiety) to 80 (severe trait anxiety). The norm for adults is 34.9+/-9.2.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.5" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hamilton Depression Rating Scale, 17-Item (HDRS-17)</title>
          <description>A scale measuring depression symptoms. Total score is reported and ranges from 0 (no depression) to 52 (most severe depression).&#xD;
Anchors:&#xD;
0-7 = no depression 8-16 = mild depression 17-25 = moderate depression &gt;25 = severe depression</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.9" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)</title>
        <description>An adapted version of the Yale-Brown Obsessive-Compulsive Scale (YBOCS) which measures change in OCD symptoms over short time frames (i.e., since the last assessment as opposed to over the past week). Total score is reported. Scores range from 0 (no symptoms) to 40 (severe symptoms).</description>
        <time_frame>Baseline was obtained at the beginning of each session. Then, change from baseline was measured following cannabis administration (minute 0) at minutes 20, 40, 60, 90, 120, and 180. This procedure was repeated for each of the 3 conditions.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High THC/Low CBD Marijuana (Cannabis)</title>
            <description>This condition involves the ingestion of marijuana (cannabis) with a high THC (5-10%) and low CBD (&lt;1%) content.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
          </group>
          <group group_id="O2">
            <title>Low THC/High CBD Marijuana (Cannabis)</title>
            <description>This condition involves the ingestion of marijuana (cannabis) with a low THC (&lt;1%) and high CBD (&gt;10%) content.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
          </group>
          <group group_id="O3">
            <title>No THC/No CBD</title>
            <description>This condition involves the ingestion of a placebo control with no THC and no CBD content.&#xD;
Placebo: Placebo control group, not receiving THC or CBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)</title>
          <description>An adapted version of the Yale-Brown Obsessive-Compulsive Scale (YBOCS) which measures change in OCD symptoms over short time frames (i.e., since the last assessment as opposed to over the past week). Total score is reported. Scores range from 0 (no symptoms) to 40 (severe symptoms).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Minute 0 (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.45" spread="7.46"/>
                    <measurement group_id="O2" value="17.00" spread="8.07"/>
                    <measurement group_id="O3" value="17.09" spread="4.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.36" spread="10.15"/>
                    <measurement group_id="O2" value="11.55" spread="9.46"/>
                    <measurement group_id="O3" value="10.91" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.09" spread="6.82"/>
                    <measurement group_id="O2" value="11.64" spread="9.91"/>
                    <measurement group_id="O3" value="9.00" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.18" spread="5.90"/>
                    <measurement group_id="O2" value="11.18" spread="10.15"/>
                    <measurement group_id="O3" value="9.27" spread="3.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.00" spread="4.80"/>
                    <measurement group_id="O2" value="9.91" spread="7.62"/>
                    <measurement group_id="O3" value="12.18" spread="7.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 120</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.00" spread="5.44"/>
                    <measurement group_id="O2" value="9.64" spread="5.89"/>
                    <measurement group_id="O3" value="11.09" spread="6.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.18" spread="6.35"/>
                    <measurement group_id="O2" value="11.64" spread="10.12"/>
                    <measurement group_id="O3" value="10.00" spread="4.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Test for interaction effect between condition and time (includes all three groups and all time points)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.</non_inferiority_desc>
            <p_value>.577</p_value>
            <method>Linear mixed effects regression</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Test for main effect of time (includes all three groups and all time points)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>Linear mixed effects regression</method>
            <method_desc>F=10.50; df=6, 10</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Test for main effect of condition (includes all three groups and all time points)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.</non_inferiority_desc>
            <p_value>.72</p_value>
            <method>Linear mixed effects regression</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spielberger State-Trait Anxiety Scale: State Version (STAI-S)</title>
        <description>A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).</description>
        <time_frame>Baseline obtained at the beginning of the session (Minutes 0), and then the scale was obtained at minutes 20, 40, 60, 90, 120, and 180 after cannabis administration.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High THC/Low CBD Marijuana (Cannabis)</title>
            <description>This condition involves the ingestion of marijuana (cannabis) with a high THC (5-10%) and low CBD (&lt;1%) content.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
          </group>
          <group group_id="O2">
            <title>Low THC/High CBD Marijuana (Cannabis)</title>
            <description>This condition involves the ingestion of marijuana (cannabis) with a low THC (&lt;1%) and high CBD (&gt;10%) content.&#xD;
Cannabis: THC and CBD are &quot;cannabinoids&quot; which are found naturally in the marijuana plant. Both act on the brain's &quot;endocannabinoid system,&quot; which has been hypothesized to play a role in OCD.</description>
          </group>
          <group group_id="O3">
            <title>No THC/No CBD</title>
            <description>This condition involves the ingestion of a placebo control with no THC and no CBD content.&#xD;
Placebo: Placebo control group, not receiving THC or CBD.</description>
          </group>
        </group_list>
        <measure>
          <title>Spielberger State-Trait Anxiety Scale: State Version (STAI-S)</title>
          <description>A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Minute 0 (baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.18" spread="15.37"/>
                    <measurement group_id="O2" value="45.00" spread="14.30"/>
                    <measurement group_id="O3" value="42.27" spread="10.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.00" spread="21.37"/>
                    <measurement group_id="O2" value="37.55" spread="15.28"/>
                    <measurement group_id="O3" value="29.73" spread="7.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.00" spread="13.54"/>
                    <measurement group_id="O2" value="36.00" spread="15.63"/>
                    <measurement group_id="O3" value="29.36" spread="7.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.00" spread="10.49"/>
                    <measurement group_id="O2" value="36.82" spread="14.83"/>
                    <measurement group_id="O3" value="32.27" spread="9.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.91" spread="11.48"/>
                    <measurement group_id="O2" value="34.64" spread="10.56"/>
                    <measurement group_id="O3" value="35.91" spread="10.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 120</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.09" spread="12.47"/>
                    <measurement group_id="O2" value="35.18" spread="8.67"/>
                    <measurement group_id="O3" value="34.09" spread="9.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minute 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.18" spread="10.65"/>
                    <measurement group_id="O2" value="37.45" spread="15.64"/>
                    <measurement group_id="O3" value="32.45" spread="9.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Test for interaction between condition and time</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.</non_inferiority_desc>
            <p_value>.577</p_value>
            <method>Linear mixed effects regression</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Test for main effect of time</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>Linear mixed effects regression</method>
            <method_desc>F=7.00, df=6,10</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Test for main effect of condition</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo [PBO]), time point, and their interaction.</non_inferiority_desc>
            <p_value>.002</p_value>
            <method>Linear mixed effects regression</method>
            <method_desc>F=6.26, df=2, 10</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over the course of all 3 sessions, an average of 38 days.</time_frame>
      <desc>Participants in this preliminary study were randomized to receive high THC/low CBD cannabis (&quot;THC&quot;), low THC/high CBD cannabis (&quot;CBD&quot;), and inert placebo cannabis (&quot;PBO&quot;), in random order. The total number of participants who received each possible order is listed below:&#xD;
Order A (THC, CBD, PBO) = 2 Order B (THC, PBO, CBD) = 2 Order C (CBD, THC, PBO) = 4 Order D (CBD, PBO, THC) = 0 Order E (PBO, THC, CBD) = 1 Order F (PBO, CBD, THC) = 3</desc>
      <group_list>
        <group group_id="E1">
          <title>High THC/Low CBD Cannabis</title>
          <description>Adverse events after receiving High THC (5-10%)/Low CBD (&lt;1%) cannabis</description>
        </group>
        <group group_id="E2">
          <title>High CBD/Low THC Cannabis</title>
          <description>Adverse events after receiving Low THC (&lt;1%)/High CBD (5-10%) cannabis</description>
        </group>
        <group group_id="E3">
          <title>Placebo Cannabis</title>
          <description>Adverse events after receiving placebo (0% THC/ 0% CBD) cannabis</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Reilly Kayser</name_or_title>
      <organization>Columbia University/New York State Psychiatric Institute</organization>
      <phone>6467748118</phone>
      <email>reilly.kayser@nyspi.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03274440
org study id: # 7405
nct id: NCT03274440
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this pilot research study is to test whether certain components of the
      marijuana plant, known as "cannabinoids", may help to reduce symptoms in patients with OCD.
      Specifically, patients enrolled in the study will smoke marijuana containing different
      concentrations of 2 different cannabinoids, THC and CBD. Both of these agents act on the
      brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Neither
      compound is currently FDA-approved for treating OCD.
Prior research suggests that certain areas of the brain are receptive to chemicals like those
      found in the cannabis (marijuana) plant, known as cannabinoids, and that these regions may be
      involved in anxiety disorders and OCD. More recent data shows that synthetic drugs that
      target these systems may be helpful in conditions related to OCD like anxiety disorders and
      Tourette's syndrome. Thus, these substances could also possibly be useful to treat OCD
      symptoms. However, to date there has been little research regarding the role of cannabinoids
      in OCD.

      The purpose of this study is to examine the effects of different cannabinoids on OCD symptoms
      in humans. To accomplish this in a laboratory setting, patients with OCD who are also
      occasional cannabis users will receive different combinations of two of the most well-studied
      cannabinoids, delta-9-tetrahydrocannabinol (THC, the main psychoactive component in cannabis)
      and cannabidiol (CBD, another component of the cannabis plant). We will then measure acute
      effects on OCD symptoms, anxiety, intoxication, and cardiovascular outcomes (i.e. blood
      pressure and heart rate).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Yale-Brown Obsessive-Compulsive Challenge Scale (YBOC-CS)
time frame: Baseline was obtained at the beginning of each session. Then, change from baseline was measured following cannabis administration (minute 0) at minutes 20, 40, 60, 90, 120, and 180. This procedure was repeated for each of the 3 conditions.
description: An adapted version of the Yale-Brown Obsessive-Compulsive Scale (YBOCS) which measures change in OCD symptoms over short time frames (i.e., since the last assessment as opposed to over the past week). Total score is reported. Scores range from 0 (no symptoms) to 40 (severe symptoms).
measure: Spielberger State-Trait Anxiety Scale: State Version (STAI-S)
time frame: Baseline obtained at the beginning of the session (Minutes 0), and then the scale was obtained at minutes 20, 40, 60, 90, 120, and 180 after cannabis administration.
description: A scale measuring state (acute) anxiety. Total score is reported. Scores range from 20 (no state anxiety) to 80 (severe state anxiety).
arm group label: High THC/Low CBD Marijuana
arm group type: Experimental
description: This condition involves the ingestion of marijuana with a high THC (5-10%) and low CBD (<1%) content.
arm group label: Low THC/High CBD Marijuana
arm group type: Experimental
description: This condition involves the ingestion of marijuana with a low THC (<1%) and high CBD (>10%) content.
arm group label: No THC/No CBD
arm group type: Placebo Comparator
description: This condition involves the ingestion of a placebo control with no THC and no CBD content.
intervention type: Drug
intervention name: Cannabis
description: THC and CBD are "cannabinoids" which are found naturally in the marijuana plant. Both act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.
arm group label: High THC/Low CBD Marijuana
arm group label: Low THC/High CBD Marijuana
other name: marijuana
intervention type: Other
intervention name: Placebo
description: Placebo control group, not receiving THC or CBD.
arm group label: No THC/No CBD
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: No
last name: Reilly Kayser, M.D.
role: Principal Investigator
affiliation: New York State Psychiatric Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Reilly R. Kayser
investigator title: Resident
mesh term: Marijuana Abuse
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 