<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/NCT03832816</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00199386</org_study_id>
    <nct_id>NCT03832816</nct_id>
  </id_info>
  <brief_title>Behavioral and Physiological Effects of THC and CBD</brief_title>
  <official_title>Behavioral and Physiological Effects of delta9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      This study will evaluate physiological and behavioral responses to vaporized&#xD;
      delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research&#xD;
      Unit (BPRU). In this between-subjects study, participants will be randomized to complete 1 of&#xD;
      8 possible acute drug administration sessions in which participants will administer THC&#xD;
      alone, CBD alone, THC and CBD together, or placebo. Following drug administration,&#xD;
      participants will complete a performance session and complete a battery of questionnaires&#xD;
      assessing subjective drug effects, mood, affect, and mental state. Vital signs and hormone&#xD;
      levels will also be assessed before and after drug administration. The study will help the&#xD;
      investigators understand the individual and interactive effects of THC and CBD, the two most&#xD;
      common cannabis constituents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    cancellation of funding contract&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>placebo controlled, double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood cortisol levels</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood Adrenocorticotropic hormone (ACTH) levels</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Peak change in rate (in beats per minute)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Peak change in composite STAI score. Scale consists of 20 items assessing state anxiety levels; each item is on 4 point Likert scale ranging from 1 (not at all) to 4 (almost always). Items are summed to obtain a composite score which can range from 20 to 80 (higher scores indicate more anxiety).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mood state as assessed by the The Profile of Mood States (POMS)</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Peak change in total tension-anxiety sub-scale score for POMS. This sub-scale of the POMS consists of 9 items, each on a 4-point Likert scale ranging from 1 (not at all) to 4 (extremely) which are summed to create a total score of 9 to 36 (higher scores indicate more tension/anxiety).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Peak change in total positive affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Peak change in total negative affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective rating of &quot;Drug Effect&quot; as assessed via the Drug Effect Questionnaire</measure>
    <time_frame>Prior to drug exposure and for 4 hours post-exposure.</time_frame>
    <description>Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.</description>
  </primary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Distilled Water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaporized THC alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5mg pure THC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaporized low CBD alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50mg pure CBD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaporized medium CBD alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100mg pure CBD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaporized high CBD alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200mg pure CBD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaporized low CBD with THC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50mg pure CBD paired with 5mg THC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaporized medium CBD with THC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100mg pure CBD paired with 5mg THC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaporized high CBD with THC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200mg pure CBD paired with 5mg THC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo vapor (distilled water)</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>distilled water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaporized THC alone</intervention_name>
    <description>Acute exposure to vaporized THC</description>
    <arm_group_label>Vaporized THC alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaporized CBD alone</intervention_name>
    <description>Acute exposure to vaporized CBD</description>
    <arm_group_label>Vaporized high CBD alone</arm_group_label>
    <arm_group_label>Vaporized low CBD alone</arm_group_label>
    <arm_group_label>Vaporized medium CBD alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaporized CBD with THC</intervention_name>
    <description>Acute exposure to vaporized CBD with THC</description>
    <arm_group_label>Vaporized high CBD with THC</arm_group_label>
    <arm_group_label>Vaporized low CBD with THC</arm_group_label>
    <arm_group_label>Vaporized medium CBD with THC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have provided written informed consent&#xD;
&#xD;
          -  Be between the ages of 18 and 50&#xD;
&#xD;
          -  Be in good general health based on a physical examination, medical history, vital&#xD;
             signs, and screening urine and blood tests&#xD;
&#xD;
          -  Willingness to provide urine sample at the screening visit and again upon admission&#xD;
             for the experimental session&#xD;
&#xD;
          -  Test negative for recent drug or alcohol use at the screening visit and upon arrival&#xD;
             for each experimental session.&#xD;
&#xD;
          -  Not be pregnant or nursing (if female). All females must have a negative pregnancy&#xD;
             test at the screening visit and at clinic admission.&#xD;
&#xD;
          -  BMI 18-36&#xD;
&#xD;
          -  Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of&#xD;
             150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg&#xD;
&#xD;
          -  Occasional/Intermittent cannabis users.&#xD;
&#xD;
          -  Have not donated blood in the prior 30 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent non-medical use of psychoactive drugs;&#xD;
&#xD;
          -  History of or current evidence of significant medical or psychiatric illness&#xD;
&#xD;
          -  any condition (as determined by the study physician or investigator) that puts the&#xD;
             participant at greater risk.&#xD;
&#xD;
          -  Recent use of an over the counter (OTC), systemic or topical drug(s), herbal&#xD;
             supplement(s), or vitamin(s) which, in the opinion of the investigator or sponsor,&#xD;
             will interfere with the study result or the safety of the subject.&#xD;
&#xD;
          -  Recent use of a prescription medication (with the exception of hormonal birth control&#xD;
             prescriptions) which, in the opinion of the investigator or sponsor, will interfere&#xD;
             with the study result or the safety of the subject. This includes any medication&#xD;
             metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.&#xD;
&#xD;
          -  Recent use of hemp seeds or hemp oil.&#xD;
&#xD;
          -  Recent use of dronabinol (Marinol).&#xD;
&#xD;
          -  History of clinically significant cardiac arrhythmias or vasospastic disease (e.g.,&#xD;
             Prinzmetal's angina).&#xD;
&#xD;
          -  Recently enrolled in another clinical trial or have recently received any drug as part&#xD;
             of a research study.&#xD;
&#xD;
          -  Epilepsy or a history of seizures.&#xD;
&#xD;
          -  Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI&#xD;
             and have current sequela from prior brain injury, as determined by the study physician&#xD;
&#xD;
          -  Individuals with anemia&#xD;
&#xD;
          -  5th grade reading level or lower.&#xD;
&#xD;
          -  Clinically relevant anxiety.&#xD;
&#xD;
          -  Individuals who are night shift workers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elise Weerts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ryan Vandrey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Behavioral Pharmacology Research Unit</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>August 1, 2019</last_update_submitted>
  <last_update_submitted_qc>August 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cortisol</keyword>
  <keyword>ACTH</keyword>
  <keyword>Heart rate</keyword>
  <keyword>delta9-Tetrahydrocannabinol</keyword>
  <keyword>cannabidiol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dronabinol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03832816
org study id: IRB00199386
nct id: NCT03832816
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate physiological and behavioral responses to vaporized
      delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research
      Unit (BPRU). In this between-subjects study, participants will be randomized to complete 1 of
      8 possible acute drug administration sessions in which participants will administer THC
      alone, CBD alone, THC and CBD together, or placebo. Following drug administration,
      participants will complete a performance session and complete a battery of questionnaires
      assessing subjective drug effects, mood, affect, and mental state. Vital signs and hormone
      levels will also be assessed before and after drug administration. The study will help the
      investigators understand the individual and interactive effects of THC and CBD, the two most
      common cannabis constituents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
masking description: placebo controlled, double-blind
measure: Change in blood cortisol levels
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured
measure: Change in blood Adrenocorticotropic hormone (ACTH) levels
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured
measure: Change in heart rate
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Peak change in rate (in beats per minute)
measure: Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI)
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Peak change in composite STAI score. Scale consists of 20 items assessing state anxiety levels; each item is on 4 point Likert scale ranging from 1 (not at all) to 4 (almost always). Items are summed to obtain a composite score which can range from 20 to 80 (higher scores indicate more anxiety).
measure: Change in Mood state as assessed by the The Profile of Mood States (POMS)
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Peak change in total tension-anxiety sub-scale score for POMS. This sub-scale of the POMS consists of 9 items, each on a 4-point Likert scale ranging from 1 (not at all) to 4 (extremely) which are summed to create a total score of 9 to 36 (higher scores indicate more tension/anxiety).
measure: Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Peak change in total positive affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
measure: Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Peak change in total negative affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
measure: Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire
time frame: Prior to drug exposure and for 4 hours post-exposure.
description: Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
arm group label: Placebo
arm group type: Placebo Comparator
description: Distilled Water
arm group label: Vaporized THC alone
arm group type: Experimental
description: 5mg pure THC
arm group label: Vaporized low CBD alone
arm group type: Experimental
description: 50mg pure CBD
arm group label: Vaporized medium CBD alone
arm group type: Experimental
description: 100mg pure CBD
arm group label: Vaporized high CBD alone
arm group type: Experimental
description: 200mg pure CBD
arm group label: Vaporized low CBD with THC
arm group type: Experimental
description: 50mg pure CBD paired with 5mg THC
arm group label: Vaporized medium CBD with THC
arm group type: Experimental
description: 100mg pure CBD paired with 5mg THC
arm group label: Vaporized high CBD with THC
arm group type: Experimental
description: 200mg pure CBD paired with 5mg THC
intervention type: Drug
intervention name: Placebo
description: Placebo vapor (distilled water)
arm group label: Placebo
other name: distilled water
intervention type: Drug
intervention name: Vaporized THC alone
description: Acute exposure to vaporized THC
arm group label: Vaporized THC alone
intervention type: Drug
intervention name: Vaporized CBD alone
description: Acute exposure to vaporized CBD
arm group label: Vaporized high CBD alone
arm group label: Vaporized low CBD alone
arm group label: Vaporized medium CBD alone
intervention type: Drug
intervention name: Vaporized CBD with THC
description: Acute exposure to vaporized CBD with THC
arm group label: Vaporized high CBD with THC
arm group label: Vaporized low CBD with THC
arm group label: Vaporized medium CBD with THC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elise Weerts, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Ryan Vandrey, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dronabinol