<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/NCT04451863</url>
  </required_header>
  <id_info>
    <org_study_id>19-001519</org_study_id>
    <secondary_id>R01AT010762</secondary_id>
    <nct_id>NCT04451863</nct_id>
  </id_info>
  <brief_title>Analgesic and Subjective Effects of Terpenes</brief_title>
  <official_title>Analgesic and Subjective Effects of Terpenes Administered Alone and in Combination With THC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</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 research is to assess the analgesic and subjective effects of terpenes&#xD;
      administered alone and in combination of THC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall aim of this placebo-controlled study is to examine dose-dependent analgesia,&#xD;
      intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of&#xD;
      vaporized myrcene and beta-caryophyllene administered alone or with vaporized THC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 15, 2021</start_date>
  <completion_date type="Anticipated">March 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2024</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesia as measured using the Cold Pressor Test</measure>
    <time_frame>7 hours</time_frame>
    <description>Pain threshold and pain tolerance assessed using the Cold Pressor Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject-rated drug effects of abuse liability</measure>
    <time_frame>7 hours</time_frame>
    <description>Subject ratings of &quot;Good Drug Effect&quot; as measured using a visual analog scale (1-100 mm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject-rated drug effects of intoxication</measure>
    <time_frame>7 hours</time_frame>
    <description>Subject ratings of &quot;High&quot; as measured using a visual analog scale (1-100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective ratings of pain</measure>
    <time_frame>7 hours</time_frame>
    <description>Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test</description>
  </secondary_outcome>
  <number_of_arms>15</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Pain</condition>
  <condition>Abuse, Drug</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 mg THC, 0 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low strength THC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 mg THC, 0 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Higher strength THC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 mg THC, 0 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low strength myrcene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0 mg THC, 0.5 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High strength myrcene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0 mg THC, 12.0 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low strength BCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0 mg THC, 0 mg myrcene, 0.5 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High strength BCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 mg THC, 0 mg myrcene, 7.5 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low THC + Low myrcene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 mg THC, 0.5 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low THC + High myrcene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 mg THC, 12.0 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High THC + Low myrcerne</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 mg THC, 0.5 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High THC + High myrcene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 mg THC, 12.0 mg myrcene, 0 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low THC + Low BCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 mg THC, 0 mg myrcene, 0.5 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low THC + High BCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 mg THC, 0 mg myrcene, 7.5 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High THC + Low BCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 mg THC, 0 mg myrcene, 0.5 mg BCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High THC + High BCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 mg THC, 0 mg myrcene, 7.5 mg BCP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low THC</intervention_name>
    <description>Vaporized THC (5 mg)</description>
    <arm_group_label>Low THC + High BCP</arm_group_label>
    <arm_group_label>Low THC + High myrcene</arm_group_label>
    <arm_group_label>Low THC + Low BCP</arm_group_label>
    <arm_group_label>Low THC + Low myrcene</arm_group_label>
    <arm_group_label>Low strength THC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High THC</intervention_name>
    <description>Vaporized THC (15 mg)</description>
    <arm_group_label>High THC + High BCP</arm_group_label>
    <arm_group_label>High THC + High myrcene</arm_group_label>
    <arm_group_label>High THC + Low BCP</arm_group_label>
    <arm_group_label>High THC + Low myrcerne</arm_group_label>
    <arm_group_label>High strength BCP</arm_group_label>
    <arm_group_label>Higher strength THC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Myrcene</intervention_name>
    <description>Vaporized Myrcene (0.5 mg)</description>
    <arm_group_label>High THC + Low myrcerne</arm_group_label>
    <arm_group_label>Low THC + Low myrcene</arm_group_label>
    <arm_group_label>Low strength myrcene</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High Myrcene</intervention_name>
    <description>Vaporized Myrcene (12.0 mg)</description>
    <arm_group_label>High THC + High myrcene</arm_group_label>
    <arm_group_label>High strength myrcene</arm_group_label>
    <arm_group_label>Low THC + High myrcene</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Beta-Caryophyllene</intervention_name>
    <description>Vaporized Beta-Caryophyllene (0.5 mg)</description>
    <arm_group_label>High THC + Low BCP</arm_group_label>
    <arm_group_label>Low THC + Low BCP</arm_group_label>
    <arm_group_label>Low strength BCP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High Beta-Caryophyllene</intervention_name>
    <description>Vaporized Beta-Caryophyllene (7.5 mg)</description>
    <arm_group_label>High THC + High BCP</arm_group_label>
    <arm_group_label>High strength BCP</arm_group_label>
    <arm_group_label>Low THC + High BCP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Vaporized Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant female aged 21-55 years&#xD;
&#xD;
          -  Report non-medical use of cannabis 1-7 days per week over the 1 month prior to&#xD;
             screening&#xD;
&#xD;
          -  Not currently seeking treatment for cannabis use&#xD;
&#xD;
          -  Urine test positive for recent cannabis use&#xD;
&#xD;
          -  Have a Body Mass Index from 18.5 - 34kg/m2.&#xD;
&#xD;
          -  Able to perform all study procedures&#xD;
&#xD;
          -  Must be using a contraceptive method (hormonal or barrier methods)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine,&#xD;
             or mild CUD&#xD;
&#xD;
          -  Report using other illicit drugs in the prior 4 weeks&#xD;
&#xD;
          -  • If medical history, physical and psychiatric examination, or laboratory tests&#xD;
             performed during the screening process not within the normal range and / or reveal any&#xD;
             significant illness (e.g., hypertension) as judged by the study physician and to put&#xD;
             the participant at greater risk of experiencing adverse events due to completion of&#xD;
             study procedures.&#xD;
&#xD;
          -  Current licit use of cannabis primarily for medical purposes, prescription analgesics,&#xD;
             or any medications that may affect study outcomes&#xD;
&#xD;
          -  Current pain&#xD;
&#xD;
          -  Pregnancy is exclusionary due to the possible effects of the study medication on fetal&#xD;
             development.&#xD;
&#xD;
          -  History of an allergic reaction or adverse reaction to cannabis is exclusionary.&#xD;
&#xD;
          -  History of respiratory illness or current respiratory illness&#xD;
&#xD;
          -  History of seizure disorder or current seizure disorder&#xD;
&#xD;
          -  Insensitivity to the cold water stimulus of the Cold Pressor Test&#xD;
&#xD;
          -  Currently enrolled in another research protocol&#xD;
&#xD;
          -  Current major Axis 1 disorders (mood, anxiety, or psychotic disorder)&#xD;
&#xD;
          -  Not using a contraceptive method (hormonal or barrier methods)&#xD;
&#xD;
          -  The evaluating physician reviews all medical assessments along with medical history.&#xD;
             Any disorders that might make cannabis administration hazardous are exclusionary.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ziva Cooper, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ziva Cooper, PhD</last_name>
    <phone>310-206-9942</phone>
    <email>zcooper@mednet.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vincent Acebo</last_name>
    <phone>310-983-3417</phone>
    <email>vacebo@mednet.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ziva Cooper, Phd</last_name>
      <phone>310-206-9942</phone>
      <email>zcooper@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Vincent Acebo</last_name>
      <phone>310-983-3417</phone>
      <email>vacebo@mednet.ucla.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Ziva Cooper, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Ziva D. Cooper, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cannabis</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Pain</keyword>
  <keyword>THC</keyword>
  <keyword>Terpenes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caryophyllene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451863
org study id: 19-001519
secondary id: R01AT010762
nct id: NCT04451863
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this research is to assess the analgesic and subjective effects of terpenes
      administered alone and in combination of THC.
The overall aim of this placebo-controlled study is to examine dose-dependent analgesia,
      intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of
      vaporized myrcene and beta-caryophyllene administered alone or with vaporized THC.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Analgesia as measured using the Cold Pressor Test
time frame: 7 hours
description: Pain threshold and pain tolerance assessed using the Cold Pressor Test
measure: Subject-rated drug effects of abuse liability
time frame: 7 hours
description: Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
measure: Subject-rated drug effects of intoxication
time frame: 7 hours
description: Subject ratings of "High" as measured using a visual analog scale (1-100 mm)
measure: Subjective ratings of pain
time frame: 7 hours
description: Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test
arm group label: Placebo
arm group type: Placebo Comparator
description: 0 mg THC, 0 mg myrcene, 0 mg BCP
arm group label: Low strength THC
arm group type: Active Comparator
description: 5 mg THC, 0 mg myrcene, 0 mg BCP
arm group label: Higher strength THC
arm group type: Active Comparator
description: 15 mg THC, 0 mg myrcene, 0 mg BCP
arm group label: Low strength myrcene
arm group type: Active Comparator
description: 0 mg THC, 0.5 mg myrcene, 0 mg BCP
arm group label: High strength myrcene
arm group type: Active Comparator
description: 0 mg THC, 12.0 mg myrcene, 0 mg BCP
arm group label: Low strength BCP
arm group type: Active Comparator
description: 0 mg THC, 0 mg myrcene, 0.5 mg BCP
arm group label: High strength BCP
arm group type: Active Comparator
description: 15 mg THC, 0 mg myrcene, 7.5 mg BCP
arm group label: Low THC + Low myrcene
arm group type: Active Comparator
description: 5 mg THC, 0.5 mg myrcene, 0 mg BCP
arm group label: Low THC + High myrcene
arm group type: Active Comparator
description: 5 mg THC, 12.0 mg myrcene, 0 mg BCP
arm group label: High THC + Low myrcerne
arm group type: Active Comparator
description: 15 mg THC, 0.5 mg myrcene, 0 mg BCP
arm group label: High THC + High myrcene
arm group type: Active Comparator
description: 15 mg THC, 12.0 mg myrcene, 0 mg BCP
arm group label: Low THC + Low BCP
arm group type: Active Comparator
description: 5 mg THC, 0 mg myrcene, 0.5 mg BCP
arm group label: Low THC + High BCP
arm group type: Active Comparator
description: 5 mg THC, 0 mg myrcene, 7.5 mg BCP
arm group label: High THC + Low BCP
arm group type: Active Comparator
description: 15 mg THC, 0 mg myrcene, 0.5 mg BCP
arm group label: High THC + High BCP
arm group type: Active Comparator
description: 15 mg THC, 0 mg myrcene, 7.5 mg BCP
intervention type: Drug
intervention name: Low THC
description: Vaporized THC (5 mg)
arm group label: Low THC + High BCP
arm group label: Low THC + High myrcene
arm group label: Low THC + Low BCP
arm group label: Low THC + Low myrcene
arm group label: Low strength THC
intervention type: Drug
intervention name: High THC
description: Vaporized THC (15 mg)
arm group label: High THC + High BCP
arm group label: High THC + High myrcene
arm group label: High THC + Low BCP
arm group label: High THC + Low myrcerne
arm group label: High strength BCP
arm group label: Higher strength THC
intervention type: Drug
intervention name: Low Myrcene
description: Vaporized Myrcene (0.5 mg)
arm group label: High THC + Low myrcerne
arm group label: Low THC + Low myrcene
arm group label: Low strength myrcene
intervention type: Drug
intervention name: High Myrcene
description: Vaporized Myrcene (12.0 mg)
arm group label: High THC + High myrcene
arm group label: High strength myrcene
arm group label: Low THC + High myrcene
intervention type: Drug
intervention name: Low Beta-Caryophyllene
description: Vaporized Beta-Caryophyllene (0.5 mg)
arm group label: High THC + Low BCP
arm group label: Low THC + Low BCP
arm group label: Low strength BCP
intervention type: Drug
intervention name: High Beta-Caryophyllene
description: Vaporized Beta-Caryophyllene (7.5 mg)
arm group label: High THC + High BCP
arm group label: High strength BCP
arm group label: Low THC + High BCP
intervention type: Drug
intervention name: Placebo
description: Vaporized Placebo
arm group label: Placebo
criteria: 
gender: All
gender based: Yes
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ziva Cooper, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Ziva Cooper, PhD
phone: 310-206-9942
email: zcooper@mednet.ucla.edu
last name: Vincent Acebo
phone: 310-983-3417
email: vacebo@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Ziva D. Cooper, PhD
investigator title: Associate Professor
mesh term: Substance-Related Disorders
mesh term: Caryophyllene
sharing ipd: No