<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/NCT03809546</url>
  </required_header>
  <id_info>
    <org_study_id>IDT</org_study_id>
    <nct_id>NCT03809546</nct_id>
  </id_info>
  <brief_title>Individual Differences in Drug Response</brief_title>
  <acronym>IDT</acronym>
  <official_title>Differential Female Response to Δ9-tetrahydrocannabinol (THC): The Influence of Estradiol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Females are increasingly using cannabis, yet remain underrepresented in preclinical and&#xD;
      clinical cannabinoid research. This female-specific research plan will test the effects of&#xD;
      two recreationally relevant doses of oral THC and placebo in healthy females at two phases of&#xD;
      the menstrual cycle. Acute oral THC will be administered in a double-blind and&#xD;
      counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses&#xD;
      of estradiol and progesterone and self-reported responses. The main hypothesis is circulating&#xD;
      estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response.&#xD;
      The rationale for the presented work is to better understand the risks of cannabis use, in&#xD;
      order to maximize possible medical potential and minimize public health risks. The expected&#xD;
      outcome of this work is a deeper understanding of how circulating estradiol levels may&#xD;
      associate with response to THC and how the physiological response is associated with the&#xD;
      subjective response. Uncovering the individual differences in response to THC will allow for&#xD;
      more preventive action against cannabis-induced anxiety, paranoia, and psychosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <phase>Early 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Profile of Mood States (POMS)</measure>
    <time_frame>End of session (Baseline - time 0 or pre-capsule, post-capsule)</time_frame>
    <description>The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State Anxiety Inventory</measure>
    <time_frame>End of session (Baseline - time 0 or pre-capsule, post-capsule)</time_frame>
    <description>This scale measures both trait and state anxiety levels and will be administered separately. Responses for 20 trait anxiety symptom items are recorded on a 4-point Likert scale from &quot;almost never&quot; (1) to &quot;almost always&quot; (4). Range of scores is 20-80, the higher score indicating greater trait anxiety. This measure will be used to obtain baseline trait ratings of anxiety during the orientation session. The state scale contains 20 items to measure state anxiety symptoms. Participants indicate the intensity of their state feelings on a 4-point scale from &quot;not at all&quot; (1) to &quot;very much so&quot; (4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate Variability and Thoracic Impedance</measure>
    <time_frame>End of session (Baseline - time 0 or pre-capsule, post-capsule)</time_frame>
    <description>ECG and thoracic impedance measures will be amplified and processed by an integrated Mindware Bionex system (Mindware, Gahanna, OH). Respiratory sinus arrhythmia will be analyzed from the data as the measure of parasympathetic cardiac control. Pre-ejection period will be analyzed from the data as the measure of sympathetic cardiac control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drug Effects Questionnaire</measure>
    <time_frame>End of session (Baseline - time 0 or pre-capsule, post-capsule)</time_frame>
    <description>This questionnaire consists of 5 visual analogue scales measuring subjective drug effects. Participants indicate their response on a scale of 0-100: &quot;Do you feel any drug effect?&quot; (rated from &quot;none at all&quot; to &quot;a lot&quot;), &quot;Do you like the effects you are feeling now?&quot; (rated from &quot;not at all&quot; to &quot;very much&quot;), &quot;Do you dislike the effects you are feeling now?&quot; (rated from &quot;not at all&quot; to &quot;very much&quot;), &quot;Are you high?&quot; (rated from &quot;not at all&quot; to &quot;very much&quot;), and &quot;Would you like more of what you consumed, right now?&quot; (rated from &quot;not at all&quot; to &quot;very much&quot;). This measure will be used as another manipulation check to ensure the drug produced subjective effects, but it is not be specific to a certain drug class.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Differential Female Response to Δ9-tetrahydrocannabinol (THC)</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>7.5 mg THC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>15 mg THC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dronabinol</intervention_name>
    <description>THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).</description>
    <arm_group_label>15 mg THC</arm_group_label>
    <arm_group_label>7.5 mg THC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dextrose</intervention_name>
    <description>We are administering dextrose to health volunteers for our placebo group</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-35 years old, females (N=60)&#xD;
&#xD;
          -  Body Mass Index 19-26&#xD;
&#xD;
          -  High school education, fluent in English&#xD;
&#xD;
          -  Occasional cannabis users ( &lt;11 times in past 30 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of daily cannabis use&#xD;
&#xD;
          -  Past or present severe substance use disorder&#xD;
&#xD;
          -  Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia&#xD;
&#xD;
          -  Past year major depression&#xD;
&#xD;
          -  Current or past Post Traumatic Stress Disorder&#xD;
&#xD;
          -  Attention Deficit Hyperactivity Disorder&#xD;
&#xD;
          -  Cardiovascular illness, high blood pressure, abnormal electrocardiagram&#xD;
&#xD;
          -  Current medications (NO hormonal birth control or intrauterine device)&#xD;
&#xD;
          -  Pregnant or planning to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisa Pabon</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dronabinol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 6, 2022</submitted>
    <returned>March 16, 2023</returned>
  </pending_results>
  <!-- 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/NCT03809546
org study id: IDT
nct id: NCT03809546
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Females are increasingly using cannabis, yet remain underrepresented in preclinical and
      clinical cannabinoid research. This female-specific research plan will test the effects of
      two recreationally relevant doses of oral THC and placebo in healthy females at two phases of
      the menstrual cycle. Acute oral THC will be administered in a double-blind and
      counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses
      of estradiol and progesterone and self-reported responses. The main hypothesis is circulating
      estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response.
      The rationale for the presented work is to better understand the risks of cannabis use, in
      order to maximize possible medical potential and minimize public health risks. The expected
      outcome of this work is a deeper understanding of how circulating estradiol levels may
      associate with response to THC and how the physiological response is associated with the
      subjective response. Uncovering the individual differences in response to THC will allow for
      more preventive action against cannabis-induced anxiety, paranoia, and psychosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Profile of Mood States (POMS)
time frame: End of session (Baseline - time 0 or pre-capsule, post-capsule)
description: The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument
measure: State Anxiety Inventory
time frame: End of session (Baseline - time 0 or pre-capsule, post-capsule)
description: This scale measures both trait and state anxiety levels and will be administered separately. Responses for 20 trait anxiety symptom items are recorded on a 4-point Likert scale from "almost never" (1) to "almost always" (4). Range of scores is 20-80, the higher score indicating greater trait anxiety. This measure will be used to obtain baseline trait ratings of anxiety during the orientation session. The state scale contains 20 items to measure state anxiety symptoms. Participants indicate the intensity of their state feelings on a 4-point scale from "not at all" (1) to "very much so" (4).
measure: Heart Rate Variability and Thoracic Impedance
time frame: End of session (Baseline - time 0 or pre-capsule, post-capsule)
description: ECG and thoracic impedance measures will be amplified and processed by an integrated Mindware Bionex system (Mindware, Gahanna, OH). Respiratory sinus arrhythmia will be analyzed from the data as the measure of parasympathetic cardiac control. Pre-ejection period will be analyzed from the data as the measure of sympathetic cardiac control.
measure: Drug Effects Questionnaire
time frame: End of session (Baseline - time 0 or pre-capsule, post-capsule)
description: This questionnaire consists of 5 visual analogue scales measuring subjective drug effects. Participants indicate their response on a scale of 0-100: "Do you feel any drug effect?" (rated from "none at all" to "a lot"), "Do you like the effects you are feeling now?" (rated from "not at all" to "very much"), "Do you dislike the effects you are feeling now?" (rated from "not at all" to "very much"), "Are you high?" (rated from "not at all" to "very much"), and "Would you like more of what you consumed, right now?" (rated from "not at all" to "very much"). This measure will be used as another manipulation check to ensure the drug produced subjective effects, but it is not be specific to a certain drug class.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: 7.5 mg THC
arm group type: Active Comparator
arm group label: 15 mg THC
arm group type: Active Comparator
intervention type: Drug
intervention name: Dronabinol
description: THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
arm group label: 15 mg THC
arm group label: 7.5 mg THC
intervention type: Drug
intervention name: dextrose
description: We are administering dextrose to health volunteers for our placebo group
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elisa Pabon
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dronabinol
sharing ipd: No
submitted: June 6, 2022
returned: March 16, 2023