xml: <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/NCT06034314</url>
    </required_header>
    <id_info>
      <org_study_id>2000035807</org_study_id>
      <secondary_id>1R01DA052846-01</secondary_id>
      <nct_id>NCT06034314</nct_id>
    </id_info>
    <brief_title>Oral Dronabinol-HIV</brief_title>
    <official_title>Investigation of the Effects of Cannabis on the Immune-genome in People With HIV</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</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>Yale 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to define the mechanisms of cannabis on the genome of people&#xD;
        with HIV who use cannabis. The investigator aims to better understand the effect of&#xD;
        Dronabinol on immune and inflammatory functions, and whether these changes are HIV-status&#xD;
        dependent. This research may better inform public health policy regarding cannabis use.&#xD;
        Depending on the results, additional studies may also build upon this research to develop&#xD;
        more effective and specific treatments for cannabis use associated disorders.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq</measure>
      <time_frame>Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol</time_frame>
      <description>Changes at baseline, 120 minutes, and 360 minutes post oral Dronabinol. Transcriptome will be profiled by using single cell (sc)RNA-seq in blood samples. A panel of 45 cytokines and profiling of 37 immune cell types will be assessed for functional evaluation after Dronabinol administration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq</measure>
      <time_frame>Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol, up 5 years</time_frame>
      <description>Changes in chromatin structure will be profiled by using (sc)ATAC-seq and capture methylome sequencing in a subset of samples from the primary outcome. The investigator expects to identify the differentially accessible regions and DNA methylation regions between pre- and post-Dronabinol administration that are correlated with Dronabinol-induced immune gene expression in each cell type.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identification of Dronabinol related cellular gene networks in blood samples</measure>
      <time_frame>up 5 years</time_frame>
      <description>Data from scRNA-seq (Outcome 1) and scATAC-seq (Outcome 2) will be used to establish a computational strategy to identify cell type specific gene networks for Dronabinol response in PWoH and PWH samples separately and by HIV status.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>HIV</condition>
    <arm_group>
      <arm_group_label>People with HIV (PWH) with Cannabis use</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PWH with cannabis use</description>
    </arm_group>
    <arm_group>
      <arm_group_label>People without HIV (PWoH) with Cannabis use</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PWoH with Cannabis use</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dronabinol Capsules</intervention_name>
      <description>Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.</description>
      <arm_group_label>People with HIV (PWH) with Cannabis use</arm_group_label>
      <arm_group_label>People without HIV (PWoH) with Cannabis use</arm_group_label>
      <other_name>Marinol</other_name>
      <other_name>Syndros</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          PWH Inclusion Criteria:&#xD;
  &#xD;
            -  Current or past Cannabis use.&#xD;
  &#xD;
            -  HIV-positive on antiretroviral therapy.&#xD;
  &#xD;
            -  Meet criteria of viral suppression (viral load less than approximately 400 copies/ml).&#xD;
  &#xD;
            -  Good physical and mental health as determined by history, the SCID, collateral&#xD;
               information, physical and laboratory examinations, ECG, and vital signs.&#xD;
  &#xD;
            -  Women of Childbearing Potential: Must agree to use or have their partner use one&#xD;
               acceptable method of birth control throughout the study, at the discretion of the&#xD;
               principal investigator.&#xD;
  &#xD;
          PWoH Inclusion Criteria:&#xD;
  &#xD;
            -  Current or past Cannabis use.&#xD;
  &#xD;
            -  Good physical and mental health as determined by history, the SCID, collateral&#xD;
               information, physical and laboratory examinations, ECG, and vital signs.&#xD;
  &#xD;
            -  Women of Childbearing Potential: Must agree to use or have their partner use one&#xD;
               acceptable method of birth control throughout the study, at the discretion of the&#xD;
               principal investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cannabis naïve individuals.&#xD;
  &#xD;
            -  Under the age of 18 years.&#xD;
  &#xD;
            -  Unable to provide written informed consent.&#xD;
  &#xD;
            -  Unable to read or write in English.&#xD;
  &#xD;
            -  Unable to tolerate the effects of smoking approximately half a joint of cannabis (or&#xD;
               equivalent), at the discretion of the principal investigator.&#xD;
  &#xD;
            -  Major or clinically unstable medical conditions (e.g., myocardial infarction,&#xD;
               hypertension, clinically significant head injury or loss of consciousness).&#xD;
  &#xD;
            -  IQ less than 80.&#xD;
  &#xD;
            -  Diagnosis of psychosis confirmed by SCID.&#xD;
  &#xD;
            -  Other medical, psychiatric, or psychosocial history that is deemed unsuitable for&#xD;
               participation in study per PI.&#xD;
  &#xD;
            -  Has donated blood within the last 8 weeks.&#xD;
  &#xD;
            -  Sesame oil allergy.&#xD;
  &#xD;
            -  Concomitant use of other drugs that cause dizziness, confusion, sedation, or&#xD;
               somnolence such as CNS depressants (e.g., barbiturates, benzodiazepines, ethanol,&#xD;
               lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants,&#xD;
               other anticholinergic agents, muscle relaxants).&#xD;
  &#xD;
            -  Patients with cardiac disorders or concomitant use of other drugs that are associated&#xD;
               with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents,&#xD;
               atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents,&#xD;
               amitriptyline, desipramine, other tricyclic antidepressants).&#xD;
  &#xD;
            -  Patients with a history of seizures, including those receiving anti-epileptic&#xD;
               medication or with other factors that can lower the seizure threshold.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ke Xu, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Connecticut Mental Health Center</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06511</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ke Xu, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Ke Xu, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034314
  org study id: 2000035807
  secondary id: 1R01DA052846-01
  nct id: NCT06034314
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to define the mechanisms of cannabis on the genome of people
        with HIV who use cannabis. The investigator aims to better understand the effect of
        Dronabinol on immune and inflammatory functions, and whether these changes are HIV-status
        dependent. This research may better inform public health policy regarding cannabis use.
        Depending on the results, additional studies may also build upon this research to develop
        more effective and specific treatments for cannabis use associated disorders.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq
  time frame: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol
  description: Changes at baseline, 120 minutes, and 360 minutes post oral Dronabinol. Transcriptome will be profiled by using single cell (sc)RNA-seq in blood samples. A panel of 45 cytokines and profiling of 37 immune cell types will be assessed for functional evaluation after Dronabinol administration.
  measure: Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq
  time frame: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol, up 5 years
  description: Changes in chromatin structure will be profiled by using (sc)ATAC-seq and capture methylome sequencing in a subset of samples from the primary outcome. The investigator expects to identify the differentially accessible regions and DNA methylation regions between pre- and post-Dronabinol administration that are correlated with Dronabinol-induced immune gene expression in each cell type.
  measure: Identification of Dronabinol related cellular gene networks in blood samples
  time frame: up 5 years
  description: Data from scRNA-seq (Outcome 1) and scATAC-seq (Outcome 2) will be used to establish a computational strategy to identify cell type specific gene networks for Dronabinol response in PWoH and PWH samples separately and by HIV status.
  arm group label: People with HIV (PWH) with Cannabis use
  arm group type: Experimental
  description: PWH with cannabis use
  arm group label: People without HIV (PWoH) with Cannabis use
  arm group type: Experimental
  description: PWoH with Cannabis use
  intervention type: Drug
  intervention name: Dronabinol Capsules
  description: Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.
  arm group label: People with HIV (PWH) with Cannabis use
  arm group label: People without HIV (PWoH) with Cannabis use
  other name: Marinol
  other name: Syndros
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ke Xu, MD, PhD
  role: Principal Investigator
  affiliation: Yale University
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Dronabinol
  sharing ipd: No