<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/NCT03253926</url>
  </required_header>
  <id_info>
    <org_study_id>7475</org_study_id>
    <nct_id>NCT03253926</nct_id>
  </id_info>
  <brief_title>Effect of Lorcaserin on Cannabis Withdrawal and Self-administration</brief_title>
  <official_title>Effect of Lorcaserin on Cannabis Withdrawal and Self-administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</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>New York State Psychiatric Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators are interested in testing how lorcaserin influences the&#xD;
      effects of cannabis in a human laboratory model of cannabis use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have&#xD;
      developed a laboratory model to investigate the effects of potential treatment medications on&#xD;
      cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non&#xD;
      treatment-seeking cannabis smokers. In this study, the investigators are interested in&#xD;
      testing how lorcaserin influences the effects of cannabis in a human laboratory model of&#xD;
      cannabis use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cannabis Self-administration</measure>
    <time_frame>14 days</time_frame>
    <description>Number of cannabis puffs participant chooses to smoke.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Cannabis Use</condition>
  <arm_group>
    <arm_group_label>Lorcaserin + Marijuana</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Marijuana</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorcaserin</intervention_name>
    <description>Lorcaserin 10mg BID</description>
    <arm_group_label>Lorcaserin + Marijuana</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule BID</description>
    <arm_group_label>Placebo + Marijuana</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Marijuana</intervention_name>
    <description>Smoked marijuana cigarette</description>
    <arm_group_label>Lorcaserin + Marijuana</arm_group_label>
    <arm_group_label>Placebo + Marijuana</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current cannabis use&#xD;
&#xD;
          -  Able to give informed consent and perform study procedures&#xD;
&#xD;
          -  Women practicing an effective form of birth control&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any clinically significant medical diagnoses&#xD;
&#xD;
          -  History of heart disease and cardiac risk factors, severe chronic obstructive&#xD;
             pulmonary disease, uncontrolled hypertension, or diabetes&#xD;
&#xD;
          -  Current parole or probation&#xD;
&#xD;
          -  Certain psychiatric diagnoses&#xD;
&#xD;
          -  Current pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>July 2022</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <results_first_submitted>May 31, 2022</results_first_submitted>
  <results_first_submitted_qc>July 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 26, 2022</results_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</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>Margaret Haney</investigator_full_name>
    <investigator_title>Professor of Neurobiology (in Psychiatry) at CUMC</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03253926/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 29, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03253926/SAP_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03253926/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled in this study comprising two 13-day inpatient phases, each of which was preceded by two medication administration outpatient days to achieve steady-state levels prior to key behavioral measures. Each phase tested a different medication condition (lorcaserin 10 mg or placebo BID) in a within-subject design, with at least one medication-free week between phases to allow for medication clearance.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Lorcaserin + Marijuana First, Then Placebo + Marijuana</title>
          <description>Lorcaserin: Lorcaserin 10mg or 0mg BID&#xD;
Marijuana: Smoked marijuana cigarette</description>
        </group>
        <group group_id="P2">
          <title>Placebo + Marijuana First, Then Lorcaserin + Marijuana</title>
          <description>Lorcaserin: Lorcaserin 10mg or 0mg BID&#xD;
Marijuana: Smoked marijuana cigarette</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lorcaserin + Marijuana</title>
          <description>Lorcaserin: Lorcaserin 10mg or 0mg BID&#xD;
Marijuana: Smoked marijuana cigarette</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="30.9" spread="7.7"/>
                  </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="11"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cannabis Self-administration</title>
        <description>Number of cannabis puffs participant chooses to smoke.</description>
        <time_frame>14 days</time_frame>
        <population>Participants were randomly counterbalanced into each condition, such that all participants contributed to all conditions.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorcaserin + Marijuana</title>
            <description>Lorcaserin: Lorcaserin 10mg BID&#xD;
Marijuana: Smoked marijuana cigarette</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Marijuana</title>
            <description>Placebo: Placebo capsule BID&#xD;
Marijuana: Smoked marijuana cigarette</description>
          </group>
        </group_list>
        <measure>
          <title>Cannabis Self-administration</title>
          <description>Number of cannabis puffs participant chooses to smoke.</description>
          <population>Participants were randomly counterbalanced into each condition, such that all participants contributed to all conditions.</population>
          <units>puffs of cannabis chosen</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cannabis relapse: choice of cannabis puffs following 3 days of abstinence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" spread="1"/>
                    <measurement group_id="O2" value="9.2" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cannabis abstinence initiation: choice of cannabis puffs following 0 days of abstinence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" spread="1"/>
                    <measurement group_id="O2" value="7.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lorcaserin + Marijuana</title>
          <description>Lorcaserin: Lorcaserin 10mg BID&#xD;
Marijuana: Smoked marijuana cigarette</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Marijuana</title>
          <description>Placebo: Placebo capsule BID&#xD;
Marijuana: Smoked marijuana cigarette</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gastrointestinal upset</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Body pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Anxiety/Jittery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Eye dryness/discomfort</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Trouble sleeping</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </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>
    <limitations_and_caveats>There are several limitations to consider in the current study. First, given the study length, only one dose of lorcaserin was tested, though it was the FDA-approved therapeutic dose for obesity and the dose shown to reduce tobacco cigarette use in a clinical study targeting this population. Second, the sample comprised mostly men, limiting the generalizability of our conclusions.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Margaret Haney</name_or_title>
      <organization>New York State Psychiatric Institute</organization>
      <phone>646-774-6153</phone>
      <email>mh235@cumc.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/NCT03253926
org study id: 7475
nct id: NCT03253926
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
In this study, the investigators are interested in testing how lorcaserin influences the
      effects of cannabis in a human laboratory model of cannabis use.
In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have
      developed a laboratory model to investigate the effects of potential treatment medications on
      cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non
      treatment-seeking cannabis smokers. In this study, the investigators are interested in
      testing how lorcaserin influences the effects of cannabis in a human laboratory model of
      cannabis use.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Cannabis Self-administration
time frame: 14 days
description: Number of cannabis puffs participant chooses to smoke.
arm group label: Lorcaserin + Marijuana
arm group type: Experimental
arm group label: Placebo + Marijuana
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Lorcaserin
description: Lorcaserin 10mg BID
arm group label: Lorcaserin + Marijuana
intervention type: Drug
intervention name: Placebo
description: Placebo capsule BID
arm group label: Placebo + Marijuana
intervention type: Drug
intervention name: Marijuana
description: Smoked marijuana cigarette
arm group label: Lorcaserin + Marijuana
arm group label: Placebo + Marijuana
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Margaret Haney
investigator title: Professor of Neurobiology (in Psychiatry) at CUMC
mesh term: Marijuana Abuse
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There are several limitations to consider in the current study. First, given the study length, only one dose of lorcaserin was tested, though it was the FDA-approved therapeutic dose for obesity and the dose shown to reduce tobacco cigarette use in a clinical study targeting this population. Second, the sample comprised mostly men, limiting the generalizability of our conclusions.
point of contact: 