<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/NCT03826368</url>
  </required_header>
  <id_info>
    <org_study_id>2018/07/17</org_study_id>
    <nct_id>NCT03826368</nct_id>
  </id_info>
  <brief_title>Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury</brief_title>
  <official_title>Evaluation of Hemp-Derived Botanical Dietary Supplementation to Promote Healthy Brain Function During Recovery From Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Real Time Diagnostics Ventures INC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Real Time Diagnostics Ventures INC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the proposed research is to evaluate adult subjects currently taking&#xD;
      phytocannabinoid Hemp-derived botanical supplements (HDS) during recovery from traumatic&#xD;
      brain injury. This study seeks to answer whether subjects taking HDS formulations experience&#xD;
      relief from self-reported symptoms or improved subjective well-being, sleep quality,&#xD;
      cognitive benefits, side effects and/or quantifiable changes in brain state neuronal activity&#xD;
      or stress biomarkers. We seek to answer whether regular users (once/week to multiple&#xD;
      uses/day) of HDS experience signs of dependence, addiction or physiological withdrawal. To&#xD;
      accomplish this we will use survey questions, quantitative EEG, cognitive testing and&#xD;
      salivary biomarkers to determine the effectiveness of self-initiated HDS administration. In&#xD;
      addition, we are interested in whether our objective measures allow us to understand why some&#xD;
      people are responders to HDS health benefits while others are not.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of initial funding after approval of study&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 13, 2020</start_date>
  <completion_date type="Actual">April 13, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 13, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom inventory</measure>
    <time_frame>Subjects complete the symptom inventory within 30 minutes of arriving to testing facility after signing the consent forms.</time_frame>
    <description>Sleep and broad symptom inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>qEEG frequency, brain region coherence assessment baseline measured once immediately after completion of symptom inventory at the testing facility.</measure>
    <time_frame>Subjects are assessed once immediately after completion of the symptom inventory lasting approximately 10 minutes.</time_frame>
    <description>Frequency power spectral analysis, coherence at baseline in control subjects and treatment group subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>qEEG frequency, brain region coherence assessment, pedaling RPM change measured during a 30-40 minute window after baseline testing.</measure>
    <time_frame>Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.</time_frame>
    <description>Frequency power spectral analysis, coherence before and after peddling and during memory task where the subject is asked to name or spell the months of the year backwards while pedaling and EEG measurements are taken. Auditory tones are delivered via headsets and the subject is asked to report changes when they detect a change in frequency while attending to a blinking screen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Accuracy during memory task</measure>
    <time_frame>Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.</time_frame>
    <description>Subjects are asked to spell the name of the months or weeks backwards while pedaling a stationary bicycle.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>TBI Controls</arm_group_label>
    <description>Adult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TBI HDS</arm_group_label>
    <description>Adult men and women between 18 and 55. History of traumatic brain injury. Experienced taking hemp-derived botanicals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hemp-derived botanical dietary supplement</intervention_name>
    <description>Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.</description>
    <arm_group_label>TBI Controls</arm_group_label>
    <arm_group_label>TBI HDS</arm_group_label>
    <other_name>Cannabidiol</other_name>
    <other_name>CBD</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva swabs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults with a history of brain injury and experience taking hemp-derived&#xD;
        phytocannabinoid hemp supplements during the recovery period. Controls without brain injury&#xD;
        and experience with hemp supplements.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Adult male or female volunteers between the ages of 18-55 who have&#xD;
        experience a head trauma/ concussion resulting in the diagnosis of mild to moderate TBI&#xD;
        (Glasgow Coma scale score between 9-14) with less than 30 minutes of unconsciousness and&#xD;
        post-traumatic amnesia lasting less than 24 hours more than 1 month ago will be considered&#xD;
        for participation in the study. Volunteers must be able to move about the community of the&#xD;
        Denver metro area and speak fluent English. They must be able to leisurely ride a&#xD;
        stationary recumbent bicycle without assistance for 10 minutes and sit stationary for 15&#xD;
        minutes without discomfort. They must be familiar with the brand and dosing of HDS and been&#xD;
        regular users, defined as once /week up to multiple uses per day for at least 1 month in&#xD;
        the past year. They must be able to hear a 25 decibels in at least one ear and respond&#xD;
        verbally to questions while remaining still.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Medications. Most subjects may continue to take medications for other conditions. However,&#xD;
        subjects should be on stable doses of these medications for a specified period prior to&#xD;
        beginning the study. A stable dose means that there have been no changes in the drug dosage&#xD;
        during the past 2 months.&#xD;
&#xD;
        Subjects may not be current users of illegal drugs (e.g., cocaine, methamphetamine)&#xD;
        Subjects may not have an immune-relevant disease (e.g. HIV, MS, Lyme Disease) Females may&#xD;
        be pregnant or lactating and taking HDS supplementation. In the consent form we will&#xD;
        include a warning that taking cannabis related products during pregnancy or while nursing&#xD;
        could pose a danger to the development of the infant.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>April 13, 2020</last_update_submitted>
  <last_update_submitted_qc>April 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Real Time Diagnostics Ventures INC</investigator_affiliation>
    <investigator_full_name>Donald Cooper Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cannabinoid</keyword>
  <keyword>CBD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</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/NCT03826368
org study id: 2018/07/17
nct id: NCT03826368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the proposed research is to evaluate adult subjects currently taking
      phytocannabinoid Hemp-derived botanical supplements (HDS) during recovery from traumatic
      brain injury. This study seeks to answer whether subjects taking HDS formulations experience
      relief from self-reported symptoms or improved subjective well-being, sleep quality,
      cognitive benefits, side effects and/or quantifiable changes in brain state neuronal activity
      or stress biomarkers. We seek to answer whether regular users (once/week to multiple
      uses/day) of HDS experience signs of dependence, addiction or physiological withdrawal. To
      accomplish this we will use survey questions, quantitative EEG, cognitive testing and
      salivary biomarkers to determine the effectiveness of self-initiated HDS administration. In
      addition, we are interested in whether our objective measures allow us to understand why some
      people are responders to HDS health benefits while others are not.
observational model: Cohort
time perspective: Retrospective
measure: Symptom inventory
time frame: Subjects complete the symptom inventory within 30 minutes of arriving to testing facility after signing the consent forms.
description: Sleep and broad symptom inventory
measure: qEEG frequency, brain region coherence assessment baseline measured once immediately after completion of symptom inventory at the testing facility.
time frame: Subjects are assessed once immediately after completion of the symptom inventory lasting approximately 10 minutes.
description: Frequency power spectral analysis, coherence at baseline in control subjects and treatment group subjects.
measure: qEEG frequency, brain region coherence assessment, pedaling RPM change measured during a 30-40 minute window after baseline testing.
time frame: Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.
description: Frequency power spectral analysis, coherence before and after peddling and during memory task where the subject is asked to name or spell the months of the year backwards while pedaling and EEG measurements are taken. Auditory tones are delivered via headsets and the subject is asked to report changes when they detect a change in frequency while attending to a blinking screen.
measure: Subject Accuracy during memory task
time frame: Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.
description: Subjects are asked to spell the name of the months or weeks backwards while pedaling a stationary bicycle.
arm group label: TBI Controls
description: Adult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals.
arm group label: TBI HDS
description: Adult men and women between 18 and 55. History of traumatic brain injury. Experienced taking hemp-derived botanicals.
intervention type: Dietary Supplement
intervention name: Hemp-derived botanical dietary supplement
description: Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.
arm group label: TBI Controls
arm group label: TBI HDS
other name: Cannabidiol
other name: CBD
Saliva swabs
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
country: United States
responsible party type: Principal Investigator
investigator affiliation: Real Time Diagnostics Ventures INC
investigator full name: Donald Cooper Ph.D.
investigator title: Principal Investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
mesh term: Cannabidiol
sharing ipd: No