<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/NCT02231840</url>
  </required_header>
  <id_info>
    <org_study_id>140181</org_study_id>
    <secondary_id>14-AA-0181</secondary_id>
    <nct_id>NCT02231840</nct_id>
  </id_info>
  <brief_title>NIAAA Natural History Protocol</brief_title>
  <official_title>NIAAA Natural History Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow&#xD;
      people that have alcohol problems and want treatment, as well as those who do not want&#xD;
      treatment and healthy volunteers. They also want to gather information on people with and&#xD;
      without alcohol problems, including information on genes and biological processes in the&#xD;
      body.. This will help them better understand, prevent, and treat alcohol problems.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      -To look at a broad range of traits in people who are healthy people and people with alcohol&#xD;
      problems. To study them for potential eligibility for other research protocols conducted at&#xD;
      the NIH Clinical Center.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Adults age 18 and older.&#xD;
&#xD;
        -  Not being pregnant or imprisoned.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will have a physical exam. They will answer questions about their health&#xD;
           and alcohol and drug use. They will have an electrocardiogram to check their heart. They&#xD;
           will have blood, urine, and breath alcohol tests.&#xD;
&#xD;
        -  Participants without alcohol problems, or who have them but do not want treatment, can&#xD;
           sign the second consent for screening and research.&#xD;
&#xD;
        -  Participants that have alcohol problems and want treatment will be treated at the NIH&#xD;
           Clinical Center. They will be offered to sign the second consent at a later time.&#xD;
&#xD;
        -  Participants may join an inpatient treatment and detox program. It could last up to 6&#xD;
           weeks. Or they may join an outpatient program. Some may do both.&#xD;
&#xD;
        -  After discharge, participants may be called and asked questions about their drinking and&#xD;
           health.&#xD;
&#xD;
        -  If participants sign the second consent, they:&#xD;
&#xD;
        -  will complete paper- and computer-based questionnaires.&#xD;
&#xD;
        -  will give blood samples.&#xD;
&#xD;
        -  may have a brain scan using magnetic resonance imaging. They will lie on a table that&#xD;
           slides in and out of a cylinder that takes pictures. The machine makes loud noises. They&#xD;
           will get earplugs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Description:&#xD;
&#xD;
      This study represents the natural history protocol for NIAAA with the main objectives of&#xD;
      providing deep phenotyping of patients across the alcohol use spectrum. This includes Alcohol&#xD;
      Use Disorders (AUD) patients, patients with problematic drinking, social drinking, and&#xD;
      patients who are abstinent (healthy volunteers, and other volunteers). We have two groups in&#xD;
      this study. Treatment-seeking individuals (Patients that want to stop alcohol use and will&#xD;
      require medical management to achieve sobriety) and non-treatment-seeking participants&#xD;
      (Patients who want to continue their current alcohol use). A standard set of data will be&#xD;
      collected in all patients allowing us to study the impact of alcohol use in their overall&#xD;
      health.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To gather a set of characterization measures, including a standardized dataset of clinical,&#xD;
      behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole&#xD;
      genome genotypes.&#xD;
&#xD;
      Primary Endpoint:&#xD;
&#xD;
      A standardized set of data collected consistently under this protocol that will allow&#xD;
      exploratory, descriptive, or correlational studies of alcohol use and AUD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2044</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2044</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Obtain phenotypic assessments</measure>
    <time_frame>CROSS SECTIONAL</time_frame>
    <description>To gather characterization measures for individuals wishing to participate in this protocol, including a standardized set of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">7500</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Not treatment-seeking participants</arm_group_label>
    <description>Individuals who meet current or past DSM 5 criteria for AUD but are not seeking treatment. Healthy volunteers and other volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment-seeking Patients</arm_group_label>
    <description>Individuals who meet current DSM 5 criteria for AUD and are seeking treatment for it.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        We will enroll a total of 7500 participants. Any individual (Bullet)18 years of age who&#xD;
        expresses interest in participating in this study and/or other research studies offered at&#xD;
        NIAAA during the brief telephone pre-screening may be enrolled. Participants may be&#xD;
        individuals with no current or past AUD, as well as individuals who meet current or past&#xD;
        DSM criteria for AUD. Healthy volunteers and other volunteers will also be enrolled in this&#xD;
        protocol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        As this is a natural history protocol of alcohol use as a continuum, in order to be&#xD;
        eligible to participate in this study, an individual must meet the following criterion:&#xD;
&#xD;
          -  Age &gt;=18 years of age&#xD;
&#xD;
          -  Willingness to complete the study including genetic and MRI tests.&#xD;
&#xD;
        We will assign participants to one of two groups in this study:&#xD;
&#xD;
          -  Treatment-seeking individuals (Patients that want to stop alcohol use and will require&#xD;
             medical management to achieve sobriety) and&#xD;
&#xD;
          -  Non-treatment-seeking participants (Patients or healthy volunteers who want to&#xD;
             continue their current alcohol use).&#xD;
&#xD;
        All participants are initially phone-screened for eligibility and their desire for&#xD;
        treatment of AUD (or lack of it) will determine their group allocation. Their self-report&#xD;
        of health status, pregnancy, legal status, and willingness to complete the study including&#xD;
        the genetics and MRI test will be assessed in the phone screen and determine eligibility.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        This is a natural history protocol of alcohol use as a continuum. Potential participants&#xD;
        are pre-screened on the phone and, based on the information provided on the phone, the&#xD;
        following categories are excluded because they are not suitable study participants for this&#xD;
        protocol:&#xD;
&#xD;
          -  Individuals &lt; 18 years of age&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant candidates&#xD;
&#xD;
          -  Candidates having a severe medical or mental health disorder that would impair&#xD;
             participation in the study&#xD;
&#xD;
        All participants are initially phone-screened for eligibility: age, legal status,&#xD;
        pregnancy, and severe medical conditions will be assessed using information reported in the&#xD;
        phone screen to determine eligibility for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Diazgranados, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Megan S Carraco</last_name>
    <phone>(301) 496-5055</phone>
    <email>megan.carraco@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nancy Diazgranados, M.D.</last_name>
    <phone>(301) 496-7515</phone>
    <email>nancy.diazgranados@nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>NIH Clinical Center Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY dial 711</phone_ext>
      <email>ccopr@nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-AA-0181.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Kwako LE, Schwandt ML, Ramchandani VA, Diazgranados N, Koob GF, Volkow ND, Blanco C, Goldman D. Neurofunctional Domains Derived From Deep Behavioral Phenotyping in Alcohol Use Disorder. Am J Psychiatry. 2019 Sep 1;176(9):744-753. doi: 10.1176/appi.ajp.2018.18030357. Epub 2019 Jan 4. Erratum In: Am J Psychiatry. 2019 Jun 1;176(6):489.</citation>
    <PMID>30606047</PMID>
  </reference>
  <verification_date>August 25, 2023</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phenotypes</keyword>
  <keyword>Genetics</keyword>
  <keyword>Alcohol Use Disorder</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.All IDP, identifiable specimens and data from this protocol will be shared with other NIH protocols for future research, so that data collected under different studies from a single individual may be combined for analysis after IRB approval and informed consent (or waiver of consent) for the use of the data for the research is in place. Data will be shared from two locations: @@@1) The NIH Clinical Center Clinical Research Information System (CRIS) system, where we routinely store clinical patient data and implement adequate privacy protections by design; @@@2) On access controlled NIAAA servers, located in secured space to prevent physical theft of storage media, and managed by NIAAA IT in agreement with NIH data security policies. We will feed some of the data residing in CRIS and on the NIAAA servers to the NIH Biomedical Translational Research Information System (BTRIS).@@@</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting with the first patient recruited to termination of the study.</ipd_time_frame>
    <ipd_access_criteria>All IDP will be shared with other NIH protocols, so that data collected under different studies from a single individual may be combined for analysis when the receiving protocol includes informed consent or a waiver of consent for the use of this data for research. Also, identifiable specimens and data from this protocol may be shared with other protocols for future research after IRB approval and informed consent (or waiver of consent).</ipd_access_criteria>
  </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/NCT02231840
org study id: 140181
secondary id: 14-AA-0181
nct id: NCT02231840
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      - About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow
      people that have alcohol problems and want treatment, as well as those who do not want
      treatment and healthy volunteers. They also want to gather information on people with and
      without alcohol problems, including information on genes and biological processes in the
      body.. This will help them better understand, prevent, and treat alcohol problems.

      Objective:

      -To look at a broad range of traits in people who are healthy people and people with alcohol
      problems. To study them for potential eligibility for other research protocols conducted at
      the NIH Clinical Center.

      Eligibility:

        -  Adults age 18 and older.

        -  Not being pregnant or imprisoned.

      Design:

        -  Participants will have a physical exam. They will answer questions about their health
           and alcohol and drug use. They will have an electrocardiogram to check their heart. They
           will have blood, urine, and breath alcohol tests.

        -  Participants without alcohol problems, or who have them but do not want treatment, can
           sign the second consent for screening and research.

        -  Participants that have alcohol problems and want treatment will be treated at the NIH
           Clinical Center. They will be offered to sign the second consent at a later time.

        -  Participants may join an inpatient treatment and detox program. It could last up to 6
           weeks. Or they may join an outpatient program. Some may do both.

        -  After discharge, participants may be called and asked questions about their drinking and
           health.

        -  If participants sign the second consent, they:

        -  will complete paper- and computer-based questionnaires.

        -  will give blood samples.

        -  may have a brain scan using magnetic resonance imaging. They will lie on a table that
           slides in and out of a cylinder that takes pictures. The machine makes loud noises. They
           will get earplugs.
Study Description:

      This study represents the natural history protocol for NIAAA with the main objectives of
      providing deep phenotyping of patients across the alcohol use spectrum. This includes Alcohol
      Use Disorders (AUD) patients, patients with problematic drinking, social drinking, and
      patients who are abstinent (healthy volunteers, and other volunteers). We have two groups in
      this study. Treatment-seeking individuals (Patients that want to stop alcohol use and will
      require medical management to achieve sobriety) and non-treatment-seeking participants
      (Patients who want to continue their current alcohol use). A standard set of data will be
      collected in all patients allowing us to study the impact of alcohol use in their overall
      health.

      Primary Objective:

      To gather a set of characterization measures, including a standardized dataset of clinical,
      behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole
      genome genotypes.

      Primary Endpoint:

      A standardized set of data collected consistently under this protocol that will allow
      exploratory, descriptive, or correlational studies of alcohol use and AUD.
observational model: Case-Control
time perspective: Prospective
measure: Obtain phenotypic assessments
time frame: CROSS SECTIONAL
description: To gather characterization measures for individuals wishing to participate in this protocol, including a standardized set of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes
arm group label: Not treatment-seeking participants
description: Individuals who meet current or past DSM 5 criteria for AUD but are not seeking treatment. Healthy volunteers and other volunteers.
arm group label: Treatment-seeking Patients
description: Individuals who meet current DSM 5 criteria for AUD and are seeking treatment for it.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy Diazgranados, M.D.
role: Principal Investigator
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
last name: Megan S Carraco
phone: (301) 496-5055
email: megan.carraco@nih.gov
last name: Nancy Diazgranados, M.D.
phone: (301) 496-7515
email: nancy.diazgranados@nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-AA-0181.html
description: NIH Clinical Center Detailed Web Page
citation: Kwako LE, Schwandt ML, Ramchandani VA, Diazgranados N, Koob GF, Volkow ND, Blanco C, Goldman D. Neurofunctional Domains Derived From Deep Behavioral Phenotyping in Alcohol Use Disorder. Am J Psychiatry. 2019 Sep 1;176(9):744-753. doi: 10.1176/appi.ajp.2018.18030357. Epub 2019 Jan 4. Erratum In: Am J Psychiatry. 2019 Jun 1;176(6):489.
PMID: 30606047
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcohol Drinking
sharing ipd: Yes
ipd description: .All IDP, identifiable specimens and data from this protocol will be shared with other NIH protocols for future research, so that data collected under different studies from a single individual may be combined for analysis after IRB approval and informed consent (or waiver of consent) for the use of the data for the research is in place. Data will be shared from two locations: @@@1) The NIH Clinical Center Clinical Research Information System (CRIS) system, where we routinely store clinical patient data and implement adequate privacy protections by design; @@@2) On access controlled NIAAA servers, located in secured space to prevent physical theft of storage media, and managed by NIAAA IT in agreement with NIH data security policies. We will feed some of the data residing in CRIS and on the NIAAA servers to the NIH Biomedical Translational Research Information System (BTRIS).@@@
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Starting with the first patient recruited to termination of the study.
ipd access criteria: All IDP will be shared with other NIH protocols, so that data collected under different studies from a single individual may be combined for analysis when the receiving protocol includes informed consent or a waiver of consent for the use of this data for research. Also, identifiable specimens and data from this protocol may be shared with other protocols for future research after IRB approval and informed consent (or waiver of consent).