<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/NCT04436055</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00105659</org_study_id>
    <nct_id>NCT04436055</nct_id>
  </id_info>
  <brief_title>Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)</brief_title>
  <acronym>EPIC</acronym>
  <official_title>Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>John Templeton Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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 overall objective of this proposed project is to prospectively evaluate the epigenetic&#xD;
      and developmental effects of paternal cannabis and other drug use in offspring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project involves enrollment of 40 healthy mother-father dyads that are between the ages&#xD;
      of 18 and 40 years. Urine samples for qualitative drug and cotinine testing will be collected&#xD;
      from mother-father dyads, as well as quantitative THC (tetrahydrocannabinol) and THCCOOH&#xD;
      (11-nor-9-carboxy-THC) assay. A semen sample will be collected from biological fathers.&#xD;
      Relevant birth outcome data including both infant and maternal measures will be extracted&#xD;
      from the electronic health record (EHR). Infant developmental assessments will be completed&#xD;
      at approximately 6 months of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor did not renew funding.&#xD;
  </why_stopped>
  <start_date type="Actual">October 26, 2020</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Methylation profiles for fathers and offspring</measure>
    <time_frame>Intake visit for fathers; 6 months after birth for offspring</time_frame>
    <description>Examine methylation profiles from fathers with varying patterns of drug use as well as from fathers with no drug use; and determine whether methylation profiles are transmitted to offspring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in offspring</measure>
    <time_frame>Intake visit for fathers; 0-6 months for offspring</time_frame>
    <description>Electronic health record data will be used to assess a range of perinatal outcomes in babies and evaluate their association with paternal drug use status and accompanying methylation profiles in fathers and offspring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in developmental functioning in babies born to fathers using cannabis and other drugs; and to explore whether any observed differences are mediated by differences in methylation profiles of offspring saliva cells.</measure>
    <time_frame>Intake visit for fathers; 6 months for offspring</time_frame>
    <description>Developmental functioning in babies will be assessed at approximately 6 months of age and their association with paternal drug use status and accompanying methylation profiles in fathers and offspring will be evaluated. .</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Cannabis Use</condition>
  <condition>Drug Use</condition>
  <condition>Development, Infant</condition>
  <arm_group>
    <arm_group_label>All participants</arm_group_label>
    <description>All participants including cannabis users, other drug users, and non-drug users.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention will be used</intervention_name>
    <description>Since this is an observational study, there are no interventions.</description>
    <arm_group_label>All participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        40 mother-father dyads.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Both mother and father are between 18 and 40 years of age&#xD;
&#xD;
          2. Free from significant medical conditions, as determined by medical history and&#xD;
             examination from attending Obstetrician or health care provider.&#xD;
&#xD;
          3. Father is able to be contacted and consents to provide urine and sperm samples&#xD;
&#xD;
          4. Both mother and father consent to participation and for the prospective enrollment of&#xD;
             their child after birth&#xD;
&#xD;
          5. Plan on delivering their baby at one of the two main Duke-affiliated hospitals (Duke&#xD;
             University Medical Center and Duke Regional Hospital)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mother or Father currently prescribed any psychoactive medication;&#xD;
&#xD;
          2. Mother or Father unable to comply with study requirements or otherwise unsuitable for&#xD;
             participation in the opinion of the PI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Mitchell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tiffany Covas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Child and Family Study Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_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/NCT04436055
org study id: Pro00105659
nct id: NCT04436055
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of this proposed project is to prospectively evaluate the epigenetic
      and developmental effects of paternal cannabis and other drug use in offspring.
This project involves enrollment of 40 healthy mother-father dyads that are between the ages
      of 18 and 40 years. Urine samples for qualitative drug and cotinine testing will be collected
      from mother-father dyads, as well as quantitative THC (tetrahydrocannabinol) and THCCOOH
      (11-nor-9-carboxy-THC) assay. A semen sample will be collected from biological fathers.
      Relevant birth outcome data including both infant and maternal measures will be extracted
      from the electronic health record (EHR). Infant developmental assessments will be completed
      at approximately 6 months of age.
observational model: Other
time perspective: Prospective
measure: Methylation profiles for fathers and offspring
time frame: Intake visit for fathers; 6 months after birth for offspring
description: Examine methylation profiles from fathers with varying patterns of drug use as well as from fathers with no drug use; and determine whether methylation profiles are transmitted to offspring.
measure: Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in offspring
time frame: Intake visit for fathers; 0-6 months for offspring
description: Electronic health record data will be used to assess a range of perinatal outcomes in babies and evaluate their association with paternal drug use status and accompanying methylation profiles in fathers and offspring.
measure: Differences in developmental functioning in babies born to fathers using cannabis and other drugs; and to explore whether any observed differences are mediated by differences in methylation profiles of offspring saliva cells.
time frame: Intake visit for fathers; 6 months for offspring
description: Developmental functioning in babies will be assessed at approximately 6 months of age and their association with paternal drug use status and accompanying methylation profiles in fathers and offspring will be evaluated. .
arm group label: All participants
description: All participants including cannabis users, other drug users, and non-drug users.
intervention type: Other
intervention name: No Intervention will be used
description: Since this is an observational study, there are no interventions.
arm group label: All participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Mitchell, PhD
role: Principal Investigator
affiliation: Duke University
last name: Tiffany Covas, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Marijuana Abuse
sharing ipd: No