<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/NCT01697709</url>
  </required_header>
  <id_info>
    <org_study_id>6623</org_study_id>
    <secondary_id>1R01DA031826</secondary_id>
    <nct_id>NCT01697709</nct_id>
  </id_info>
  <brief_title>Quetiapine Pharmacotherapy for Cannabis Dependence</brief_title>
  <acronym>QUEST</acronym>
  <official_title>Quetiapine Pharmacotherapy for Cannabis Dependence</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>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite a benign public perception, marijuana use disorders represent a significant public&#xD;
      health problem. The development of safe and effective pharmacotherapies for marijuana&#xD;
      dependence is an important unmet public health need. Quetiapine, an effective atypical&#xD;
      antipsychotic that acts by blocking serotonin type 2A, dopamine type 2, histamine type 1, and&#xD;
      adrenergic receptors, is a promising treatment for substance use disorders. In animal models,&#xD;
      quetiapine blocks the enhancement of reward by cocaine, which is likely due to its actions on&#xD;
      both dopamine and non-dopamine neurotransmission. Clinical studies of quetiapine have shown&#xD;
      benefit for the treatment of alcohol and cocaine use disorders.&#xD;
&#xD;
      Conceptually, the clinically prominent effects of quetiapine, namely sedation, anxiolysis,&#xD;
      mood stabilization and appetite stimulation, are a good match for the symptoms of marijuana&#xD;
      withdrawal. Most importantly, an open-label dose-finding study of quetiapine for the&#xD;
      treatment of marijuana dependence conducted by our research group determined that quetiapine&#xD;
      was well-tolerated and associated with reductions in marijuana use indicating that it is a&#xD;
      promising agent deserving of further study in marijuana-dependent outpatients.&#xD;
&#xD;
      The proposed research project is a randomized double-blind placebo-controlled clinical trial&#xD;
      to evaluate the efficacy of quetiapine for the treatment of marijuana dependence over a&#xD;
      12-week period. All participants will receive Medical Management, a medication adherence&#xD;
      focused psychosocial intervention that facilitates compliance with study medication and other&#xD;
      study procedures, promotes abstinence from marijuana and other substances, and encourages&#xD;
      mutual-support group attendance. All participants will receive voucher incentives for&#xD;
      compliance with study visit attendance, returning study medication bottles, and completing&#xD;
      other study procedures, with the objective of achieving a highly compliant sample. The goal&#xD;
      of this phase II clinical trial is to build on our promising open-label pilot study results&#xD;
      and examine the efficacy of quetiapine on participants' marijuana consumption under&#xD;
      placebo-controlled double-blind conditions using an abstinence-initiation model, where&#xD;
      participants will be using marijuana regularly at study entry, reduce their use, and then&#xD;
      achieve abstinence. The specific aims of the projects are to determine whether quetiapine is&#xD;
      superior to placebo in 1) reducing marijuana use and 2) achieving abstinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a 12-week randomized double-blind placebo-controlled clinical trial, we will evaluate the&#xD;
      efficacy of quetiapine for the treatment of marijuana dependence in 150 outpatients.&#xD;
      Participants will be randomly assigned to treatment under double-blind conditions with either&#xD;
      a fixed dosing schedule of quetiapine or placebo. All participants will receive Medical&#xD;
      Management, a medication adherence focused psychosocial intervention that facilitates&#xD;
      compliance with study medication and other study procedures, and promotes abstinence from&#xD;
      marijuana and other substances. All participants will receive progressive voucher incentives&#xD;
      for compliance with study visit attendance and completing other study procedures, with the&#xD;
      objective of achieving a highly compliant sample.&#xD;
&#xD;
      The results of a dose-finding pilot study of quetiapine for the treatment of marijuana&#xD;
      dependence (see Preliminary Studies) suggests that the ideal dosing for the proposed project&#xD;
      is a single 300 mg dose every evening, achieved after a gradual three-week titration.&#xD;
      Clinical experience with this medication for treatment of marijuana dependence indicates that&#xD;
      a gradual upward titration of dose is advisable to maximize tolerability and that morning&#xD;
      dosing was poorly tolerated. Quetiapine (immediate release formulation) will be administered&#xD;
      in 25 and 100 mg capsules; placebo capsules will appear identical to the quetiapine capsules.&#xD;
      Participants in both treatment arms will take the same number of pills on the same schedule.&#xD;
      Study medication will be dispensed on a weekly basis starting with the baseline visit.&#xD;
      Quetiapine will be titrated over a three-week period to the target dose of 300 mg or the&#xD;
      maximum tolerated dose. The research psychiatrist will make dose reductions for tolerability&#xD;
      if necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">April 30, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2017</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study</measure>
    <time_frame>12 weeks or length of participants involvement</time_frame>
    <description>The median daily dollar value of marijuana used averaged over a one-week period for each of the 12 weeks as recorded by the Timeline Followback method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Stratified by Marijuana Abstinence Days Per Week</measure>
    <time_frame>12 weeks or length of participation</time_frame>
    <description>The number of abstinent days per week over the 12 weeks of study as recorded by the Timeline Followback method. High Use group defined as 0-2 abstinent days per week, Medium Use Group as 3-5 abstinent days per week and Low Use Group as 6-7 abstinent days per week.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Cannabis Dependence</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>quetiapine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quetiapine treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Quetiapine</intervention_name>
    <description>Quetiapine pharmacotherapy for cannabis dependence</description>
    <arm_group_label>quetiapine</arm_group_label>
    <other_name>Seroquel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo capsules</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Matched Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meets DSM-IV-TR criteria for current marijuana dependence&#xD;
&#xD;
          2. Reports using marijuana an average of 5 days per week over the past 28 days&#xD;
&#xD;
          3. Between the ages of 18 and 60&#xD;
&#xD;
          4. Able to provide informed consent and comply with study procedures&#xD;
&#xD;
          5. Seeking treatment for cannabis dependence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar&#xD;
             disorder.&#xD;
&#xD;
          2. Current DSM-IV criteria for any other psychiatric disorder that may, according to&#xD;
             investigator's judgment, require either pharmacological or non-pharmacological&#xD;
             intervention over the course of the study.&#xD;
&#xD;
          3. Patients prescribed psychotropic medications.&#xD;
&#xD;
          4. History of allergic reaction, intolerance, or hypersensitivity to Quetiapine.&#xD;
&#xD;
          5. Pregnancy, lactation, or failure to use adequate contraceptive methods in female&#xD;
             patients who are currently engaging in sexual activity with men.&#xD;
&#xD;
          6. Unstable medical conditions, such as poorly controlled hypertension which might make&#xD;
             participation hazardous.&#xD;
&#xD;
          7. Diabetes (whether controlled or not), meeting criteria for metabolic syndrome as&#xD;
             defined by the NCEP (any 3 of the following: a. obesity [waist circumference &gt; 40&#xD;
             inches], b. hyperglycemia [fasting glucose &gt; 100 mg/dl or Rx], c. dyslipidemia [TG &gt;&#xD;
             150 mg/dl or Rx], d. dyslipidemia [HDL cholesterol; 40 mg/dl (male), 50 mg/dl (female)&#xD;
             or Rx], e. hypertension [130 mmHg systolic or &gt; 85 mmHg diastolic or Rx]. Participants&#xD;
             with a BMI &gt; 35 will be excluded.&#xD;
&#xD;
          8. Current DSM-IV diagnosis of an alcohol or substance use disorder (abuse or dependence)&#xD;
             other than marijuana or nicotine dependence.&#xD;
&#xD;
          9. Positive confirmed result on urine toxicology screen.&#xD;
&#xD;
         10. Are legally mandated to participate in a substance use disorder treatment program.&#xD;
&#xD;
         11. Increased risk for suicide.&#xD;
&#xD;
         12. QTc prolongation (screening electrocardiogram with Qtc &gt; 450 msec for men, QTc &gt; 470&#xD;
             msec for women) or history of QTc prolongation or using concomitant medications which&#xD;
             prolong QTc interval.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John J Mariani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University/NYSPI</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>
  <link>
    <url>http://www.stars.columbia.edu</url>
    <description>Study web site</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>January 17, 2019</results_first_submitted>
  <results_first_submitted_qc>January 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2019</results_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</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>John Mariani MD</investigator_full_name>
    <investigator_title>research psychiatrist</investigator_title>
  </responsible_party>
  <keyword>cannabis</keyword>
  <keyword>marijuana</keyword>
  <keyword>pharmacotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quetiapine Fumarate</mesh_term>
  </intervention_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 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT01697709/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>November 7, 2011</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT01697709/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Patients were randomized to one of the treatment arms at time of enrollment</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo medication&#xD;
Placebo: placebo capsules</description>
        </group>
        <group group_id="P2">
          <title>Quetiapine</title>
          <description>Quetiapine treatment&#xD;
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo medication&#xD;
Placebo: placebo capsules</description>
        </group>
        <group group_id="B2">
          <title>Quetiapine</title>
          <description>Quetiapine treatment&#xD;
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
            <count group_id="B2" value="66"/>
            <count group_id="B3" value="130"/>
          </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="33.1" spread="8.7"/>
                    <measurement group_id="B2" value="32.7" spread="9.5"/>
                    <measurement group_id="B3" value="32.9" spread="9.1"/>
                  </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="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="102"/>
                  </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="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>mood/anxiety disorder</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marijuana using days past 28 days</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.8" spread="2.1"/>
                    <measurement group_id="B2" value="26.4" spread="2.5"/>
                    <measurement group_id="B3" value="26.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study</title>
        <description>The median daily dollar value of marijuana used averaged over a one-week period for each of the 12 weeks as recorded by the Timeline Followback method</description>
        <time_frame>12 weeks or length of participants involvement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo medication&#xD;
Placebo: placebo capsules</description>
          </group>
          <group group_id="O2">
            <title>Quetiapine</title>
            <description>Quetiapine treatment&#xD;
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence</description>
          </group>
        </group_list>
        <measure>
          <title>Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study</title>
          <description>The median daily dollar value of marijuana used averaged over a one-week period for each of the 12 weeks as recorded by the Timeline Followback method</description>
          <units>dollars</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.00" lower_limit="5.42" upper_limit="21.25"/>
                    <measurement group_id="O2" value="7.00" lower_limit="3.18" upper_limit="12.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.00" lower_limit="2.86" upper_limit="22.00"/>
                    <measurement group_id="O2" value="8.00" lower_limit="3.02" upper_limit="12.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.14" lower_limit="2.64" upper_limit="17.69"/>
                    <measurement group_id="O2" value="5.86" lower_limit="3.29" upper_limit="11.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.43" lower_limit="1.61" upper_limit="16.25"/>
                    <measurement group_id="O2" value="5.71" lower_limit="2.57" upper_limit="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.43" lower_limit="1.07" upper_limit="17.86"/>
                    <measurement group_id="O2" value="4.29" lower_limit="1.43" upper_limit="9.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.71" lower_limit="0.96" upper_limit="13.82"/>
                    <measurement group_id="O2" value="4.11" lower_limit="1.32" upper_limit="9.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.70" lower_limit="1.03" upper_limit="12.59"/>
                    <measurement group_id="O2" value="3.57" lower_limit="1.43" upper_limit="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" lower_limit="1.12" upper_limit="12.26"/>
                    <measurement group_id="O2" value="3.43" lower_limit="1.18" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.43" lower_limit="1.03" upper_limit="11.96"/>
                    <measurement group_id="O2" value="3.00" lower_limit="1.43" upper_limit="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.35" lower_limit="0.00" upper_limit="12.32"/>
                    <measurement group_id="O2" value="2.86" lower_limit="0.29" upper_limit="5.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.21" lower_limit="0.00" upper_limit="11.79"/>
                    <measurement group_id="O2" value="2.86" lower_limit="0.00" upper_limit="5.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.00" upper_limit="12.29"/>
                    <measurement group_id="O2" value="2.14" lower_limit="0.00" upper_limit="5.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Stratified by Marijuana Abstinence Days Per Week</title>
        <description>The number of abstinent days per week over the 12 weeks of study as recorded by the Timeline Followback method. High Use group defined as 0-2 abstinent days per week, Medium Use Group as 3-5 abstinent days per week and Low Use Group as 6-7 abstinent days per week.</description>
        <time_frame>12 weeks or length of participation</time_frame>
        <population>participants were included in the weekly analysis who were still active in the trial at each given week.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo medication&#xD;
Placebo: placebo capsules</description>
          </group>
          <group group_id="O2">
            <title>Quetiapine</title>
            <description>Quetiapine treatment&#xD;
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Stratified by Marijuana Abstinence Days Per Week</title>
          <description>The number of abstinent days per week over the 12 weeks of study as recorded by the Timeline Followback method. High Use group defined as 0-2 abstinent days per week, Medium Use Group as 3-5 abstinent days per week and Low Use Group as 6-7 abstinent days per week.</description>
          <population>participants were included in the weekly analysis who were still active in the trial at each given week.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>high use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>medium use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>over 12 weeks of study or length of participation</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo medication&#xD;
Placebo: placebo capsules</description>
        </group>
        <group group_id="E2">
          <title>Quetiapine</title>
          <description>Quetiapine treatment&#xD;
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence</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="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="34" subjects_at_risk="64"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <description>&gt;130 or &gt; 85</description>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="64"/>
                <counts group_id="E2" events="36" subjects_affected="36" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Dyslipidemia</sub_title>
                <description>TG &gt;150mg</description>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="64"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <description>&gt;100 mg</description>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="64"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>drowsiness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="64"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="66"/>
              </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>john mariani. MD</name_or_title>
      <organization>NYSPI</organization>
      <phone>212-923-3031</phone>
      <email>John.mariani@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/NCT01697709
org study id: 6623
secondary id: 1R01DA031826
nct id: NCT01697709
lead sponsor: 
collaborator: 
has dmc: Yes
Despite a benign public perception, marijuana use disorders represent a significant public
      health problem. The development of safe and effective pharmacotherapies for marijuana
      dependence is an important unmet public health need. Quetiapine, an effective atypical
      antipsychotic that acts by blocking serotonin type 2A, dopamine type 2, histamine type 1, and
      adrenergic receptors, is a promising treatment for substance use disorders. In animal models,
      quetiapine blocks the enhancement of reward by cocaine, which is likely due to its actions on
      both dopamine and non-dopamine neurotransmission. Clinical studies of quetiapine have shown
      benefit for the treatment of alcohol and cocaine use disorders.

      Conceptually, the clinically prominent effects of quetiapine, namely sedation, anxiolysis,
      mood stabilization and appetite stimulation, are a good match for the symptoms of marijuana
      withdrawal. Most importantly, an open-label dose-finding study of quetiapine for the
      treatment of marijuana dependence conducted by our research group determined that quetiapine
      was well-tolerated and associated with reductions in marijuana use indicating that it is a
      promising agent deserving of further study in marijuana-dependent outpatients.

      The proposed research project is a randomized double-blind placebo-controlled clinical trial
      to evaluate the efficacy of quetiapine for the treatment of marijuana dependence over a
      12-week period. All participants will receive Medical Management, a medication adherence
      focused psychosocial intervention that facilitates compliance with study medication and other
      study procedures, promotes abstinence from marijuana and other substances, and encourages
      mutual-support group attendance. All participants will receive voucher incentives for
      compliance with study visit attendance, returning study medication bottles, and completing
      other study procedures, with the objective of achieving a highly compliant sample. The goal
      of this phase II clinical trial is to build on our promising open-label pilot study results
      and examine the efficacy of quetiapine on participants' marijuana consumption under
      placebo-controlled double-blind conditions using an abstinence-initiation model, where
      participants will be using marijuana regularly at study entry, reduce their use, and then
      achieve abstinence. The specific aims of the projects are to determine whether quetiapine is
      superior to placebo in 1) reducing marijuana use and 2) achieving abstinence.
In a 12-week randomized double-blind placebo-controlled clinical trial, we will evaluate the
      efficacy of quetiapine for the treatment of marijuana dependence in 150 outpatients.
      Participants will be randomly assigned to treatment under double-blind conditions with either
      a fixed dosing schedule of quetiapine or placebo. All participants will receive Medical
      Management, a medication adherence focused psychosocial intervention that facilitates
      compliance with study medication and other study procedures, and promotes abstinence from
      marijuana and other substances. All participants will receive progressive voucher incentives
      for compliance with study visit attendance and completing other study procedures, with the
      objective of achieving a highly compliant sample.

      The results of a dose-finding pilot study of quetiapine for the treatment of marijuana
      dependence (see Preliminary Studies) suggests that the ideal dosing for the proposed project
      is a single 300 mg dose every evening, achieved after a gradual three-week titration.
      Clinical experience with this medication for treatment of marijuana dependence indicates that
      a gradual upward titration of dose is advisable to maximize tolerability and that morning
      dosing was poorly tolerated. Quetiapine (immediate release formulation) will be administered
      in 25 and 100 mg capsules; placebo capsules will appear identical to the quetiapine capsules.
      Participants in both treatment arms will take the same number of pills on the same schedule.
      Study medication will be dispensed on a weekly basis starting with the baseline visit.
      Quetiapine will be titrated over a three-week period to the target dose of 300 mg or the
      maximum tolerated dose. The research psychiatrist will make dose reductions for tolerability
      if necessary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
time frame: 12 weeks or length of participants involvement
description: The median daily dollar value of marijuana used averaged over a one-week period for each of the 12 weeks as recorded by the Timeline Followback method
measure: Number of Participants Stratified by Marijuana Abstinence Days Per Week
time frame: 12 weeks or length of participation
description: The number of abstinent days per week over the 12 weeks of study as recorded by the Timeline Followback method. High Use group defined as 0-2 abstinent days per week, Medium Use Group as 3-5 abstinent days per week and Low Use Group as 6-7 abstinent days per week.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo medication
arm group label: quetiapine
arm group type: Experimental
description: Quetiapine treatment
intervention type: Drug
intervention name: Quetiapine
description: Quetiapine pharmacotherapy for cannabis dependence
arm group label: quetiapine
other name: Seroquel
intervention type: Drug
intervention name: Placebo
description: placebo capsules
arm group label: Placebo
other name: Matched Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John J Mariani, MD
role: Principal Investigator
affiliation: Columbia University/NYSPI
facility: 
country: United States
url: http://www.stars.columbia.edu
description: Study web site
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: John Mariani MD
investigator title: research psychiatrist
mesh term: Marijuana Abuse
mesh term: Quetiapine Fumarate
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 