<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/NCT01668732</url>
  </required_header>
  <id_info>
    <org_study_id>MD101SCW01</org_study_id>
    <nct_id>NCT01668732</nct_id>
  </id_info>
  <brief_title>Decision Making Deficit and DNA Methylation in Opioid Receptor Genes Among Community Heroin Addicts</brief_title>
  <official_title>Decision Making Deficit and DNA Methylation in Opioid Receptor Genes Among Community Heroin Addicts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Health Research Institutes, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Health Research Institutes, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heroin addiction has emerged as a serious problem with tremendous impacts on the addicts and&#xD;
      the society. Since the introduction of opioids substitutive treatment in 2006, more than&#xD;
      30,000 heroin addicts had received treatment, and nearly 12,000 continued on treatment&#xD;
      currently. However, an unknown proportion of patients hidden in community remained&#xD;
      un-treatment. To motivate the community heroin addicts is thus a challenging task.&#xD;
&#xD;
      It is suggested that decision making deficit is core feature which determine outcomes and&#xD;
      treatment motivations in patients with addiction disorders. Recently, the state-of-the-art&#xD;
      development of epigenetics uncover that environmental modification, via altering level of DNA&#xD;
      methylation and gene expression will influence on neurocognitive functioning.&#xD;
&#xD;
      Via respondent-driven sampling, this study aims to recruit a representative sample targeting&#xD;
      at the hard-to-reach community heroin addicts. The goal of this study is to identify the&#xD;
      clinical feature as well as decision making-related neurocognitive deficit in these patients.&#xD;
      Moreover, the investigators will explore the interplay of clinical features, DNA methylation&#xD;
      and gene expressions on opioids receptor genes. The findings will help to clarify the&#xD;
      clinical characteristics of community heroin addicts, to uncover the links between DNA&#xD;
      methylation and clinical features of heroin addiction and to develop modifiable treatment&#xD;
      targets in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Heroin Addiction</condition>
  <arm_group>
    <arm_group_label>community heroin addicts</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        community heroin addicts&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) 20 to 65 of age; 2) meeting DSM-IV criteria of opioids dependence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheng Chang Wang, M.D., M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Health Research Institute, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheng Chang Wang, M.D., M.Sc.</last_name>
    <phone>886-37-246166</phone>
    <phone_ext>36703</phone_ext>
    <email>scwang69@gmail.com</email>
  </overall_contact>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 17, 2012</last_update_submitted>
  <last_update_submitted_qc>August 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</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>Heroin Dependence</mesh_term>
  </condition_browse>
  <!-- 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/NCT01668732
org study id: MD101SCW01
nct id: NCT01668732
lead sponsor: 
has dmc: No
Heroin addiction has emerged as a serious problem with tremendous impacts on the addicts and
      the society. Since the introduction of opioids substitutive treatment in 2006, more than
      30,000 heroin addicts had received treatment, and nearly 12,000 continued on treatment
      currently. However, an unknown proportion of patients hidden in community remained
      un-treatment. To motivate the community heroin addicts is thus a challenging task.

      It is suggested that decision making deficit is core feature which determine outcomes and
      treatment motivations in patients with addiction disorders. Recently, the state-of-the-art
      development of epigenetics uncover that environmental modification, via altering level of DNA
      methylation and gene expression will influence on neurocognitive functioning.

      Via respondent-driven sampling, this study aims to recruit a representative sample targeting
      at the hard-to-reach community heroin addicts. The goal of this study is to identify the
      clinical feature as well as decision making-related neurocognitive deficit in these patients.
      Moreover, the investigators will explore the interplay of clinical features, DNA methylation
      and gene expressions on opioids receptor genes. The findings will help to clarify the
      clinical characteristics of community heroin addicts, to uncover the links between DNA
      methylation and clinical features of heroin addiction and to develop modifiable treatment
      targets in the future.
observational model: Case-Only
time perspective: Cross-Sectional
arm group label: community heroin addicts
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sheng Chang Wang, M.D., M.Sc.
role: Principal Investigator
affiliation: National Health Research Institute, Taiwan
last name: Sheng Chang Wang, M.D., M.Sc.
phone: 886-37-246166
phone ext: 36703
email: scwang69@gmail.com
responsible party type: Sponsor
mesh term: Heroin Dependence