<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/NCT03268759</url>
  </required_header>
  <id_info>
    <org_study_id>0203014534</org_study_id>
    <secondary_id>1K01DA042937</secondary_id>
    <nct_id>NCT03268759</nct_id>
  </id_info>
  <brief_title>Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults</brief_title>
  <official_title>Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reward processing will be examined in prenatally exposed emerging adults in a longitudinal&#xD;
      design. Participants will be followed for one year to see if neural markers of reward&#xD;
      processing prospectively predict risk-taking behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cohort will be drawn from a pre-existing cohort of individuals recruited as part of an&#xD;
      already existing study, and who have been followed since birth. Reward processing will be&#xD;
      measured in two temporally close testing sessions involving two methodologies,&#xD;
      electrophysiology and fMRI. Information will also be collected pertaining to experimental and&#xD;
      problematic drug use, as well as information about mood, at the recording sessions. Drug use&#xD;
      and mood information will then be collected once again in quarterly follow-up sessions for&#xD;
      one year. The goal is to examine if PCE status and reward processing are risk factors for&#xD;
      problematic drug abuse and risky behaviors in emerging adulthood, and if these factors&#xD;
      interact to increase such risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">September 14, 2020</completion_date>
  <primary_completion_date type="Actual">September 14, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Risk-taking behavior:Drug and alcohol use</measure>
    <time_frame>4x per year for one year (Baseline, 4 months, 8 months, 12 months)</time_frame>
    <description>Teen Addiction Severity Index (Interview)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Risk-taking behavior:gambling behaviors</measure>
    <time_frame>4x per year for one year (Baseline, 4 months, 8 months, 12 months)</time_frame>
    <description>Massachusetts gambling screen (MAGS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in affect over time</measure>
    <time_frame>4x per year for one year (Baseline, 4 months, 8 months, 12 months)</time_frame>
    <description>Positive and Negative Affect Scales (PANAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in alexithymia over time</measure>
    <time_frame>4x per year for one year (Baseline, 4 months, 8 months, 12 months)</time_frame>
    <description>Toronto Alexithymia Scale (TAS-20)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in experience of reward</measure>
    <time_frame>4x per year for one year (Baseline, 4 months, 8 months, 12 months)</time_frame>
    <description>Chapman Social and Physical Anhedonia Questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in emotion regulation strategies</measure>
    <time_frame>4x per year for one year (Baseline, 4 months, 8 months, 12 months)</time_frame>
    <description>Emotion regulation questionaire (ERQ)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">78</enrollment>
  <condition>Pre-natal Cocaine Exposure</condition>
  <condition>Risk-Taking</condition>
  <arm_group>
    <arm_group_label>PCE</arm_group_label>
    <description>Emerging adult individuals who were exposed to cocaine in-utero</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NCE</arm_group_label>
    <description>Emerging adult individuals who were not exposed to cocaine in-utero</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fMRI</intervention_name>
    <description>Observation of neural markers of reward processing</description>
    <arm_group_label>NCE</arm_group_label>
    <arm_group_label>PCE</arm_group_label>
    <other_name>EEG</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Emerging adults in this study will be drawn from a sample of 359 individuals who have been&#xD;
        participating in a longitudinal study of the effects of PCE on physical, social, cognitive&#xD;
        and emotional development. Children and their mothers who were exposed to drugs other than&#xD;
        cocaine were also enrolled, as were non-drug exposed controls. Prenatal drug exposure&#xD;
        status was ascertained at time of recruitment via a detailed interview that covered&#xD;
        lifetime substance use and use in the past 30 days, as well as a urine screening of mother&#xD;
        and infant and meconium toxicology. The sample from which participants will be recruited&#xD;
        consists of 81% African American, 6.5% Hispanic and 12.5% Caucasian children, all of who&#xD;
        come from the greater New Haven area. The sample was recruited at birth over a 5-year&#xD;
        period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide written informed consent and to comply with all study procedures.&#xD;
&#xD;
          2. Healthy emerging adults between 18-20 years of age (the age of the currently followed&#xD;
             sample at the time of the proposed start date).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. A serious neurological or endocrine disorder or any medical condition or treatment&#xD;
             known to affect the brain. 2. A medical condition that requires treatment with a&#xD;
             medication with psychotropic effects.&#xD;
&#xD;
             3. Evidence of stroke or space occupying lesions observed on conventional, clinical MR&#xD;
             images.&#xD;
&#xD;
             4. Any contraindications to MRI scanning (i.e., metal implants, pacemakers, etc.) 5.&#xD;
             History of loss of consciousness (LOC) for longer than 30 minutes or LOC with any&#xD;
             neurological sequelae.&#xD;
&#xD;
             6. DSM-5 criteria for intellectual disability. 7. Current or a history of active&#xD;
             neurological or psychiatric disorders, such as psychosis, bipolar illness, major&#xD;
             depression, organic brain disease, dementia or DSM-V Axis I Psychiatric Disorder,&#xD;
             including current alcohol or substance disorders. Participants will not be excluded&#xD;
             for substance or alcohol use, only the presence of substance disorders.&#xD;
&#xD;
             8. Current pregnancy. Female participants will be excluded if they report being&#xD;
             currently pregnant or present positive for pregnancy after being given a urine test at&#xD;
             the time of recruitment or scanning. If they become pregnant during the one-year&#xD;
             follow-up duration of the study after the MRI scan is completed, they will remain in&#xD;
             the study for the quarterly follow-ups and be referred to pre-natal care if they have&#xD;
             not begun such care already.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Child Study Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>May 1, 2021</last_update_submitted>
  <last_update_submitted_qc>May 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>substance abuse</keyword>
  <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/NCT03268759
org study id: 0203014534
secondary id: 1K01DA042937
nct id: NCT03268759
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Reward processing will be examined in prenatally exposed emerging adults in a longitudinal
      design. Participants will be followed for one year to see if neural markers of reward
      processing prospectively predict risk-taking behavior.
This cohort will be drawn from a pre-existing cohort of individuals recruited as part of an
      already existing study, and who have been followed since birth. Reward processing will be
      measured in two temporally close testing sessions involving two methodologies,
      electrophysiology and fMRI. Information will also be collected pertaining to experimental and
      problematic drug use, as well as information about mood, at the recording sessions. Drug use
      and mood information will then be collected once again in quarterly follow-up sessions for
      one year. The goal is to examine if PCE status and reward processing are risk factors for
      problematic drug abuse and risky behaviors in emerging adulthood, and if these factors
      interact to increase such risk.
observational model: Cohort
time perspective: Prospective
measure: Change in Risk-taking behavior:Drug and alcohol use
time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
description: Teen Addiction Severity Index (Interview)
measure: Change in Risk-taking behavior:gambling behaviors
time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
description: Massachusetts gambling screen (MAGS)
measure: Change in affect over time
time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
description: Positive and Negative Affect Scales (PANAS)
measure: Change in alexithymia over time
time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
description: Toronto Alexithymia Scale (TAS-20)
measure: Change in experience of reward
time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
description: Chapman Social and Physical Anhedonia Questionnaires
measure: Change in emotion regulation strategies
time frame: 4x per year for one year (Baseline, 4 months, 8 months, 12 months)
description: Emotion regulation questionaire (ERQ)
arm group label: PCE
description: Emerging adult individuals who were exposed to cocaine in-utero
arm group label: NCE
description: Emerging adult individuals who were not exposed to cocaine in-utero
intervention type: Other
intervention name: fMRI
description: Observation of neural markers of reward processing
arm group label: NCE
arm group label: PCE
other name: EEG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No