<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/NCT01668706</url>
  </required_header>
  <id_info>
    <org_study_id>MD098SCW01</org_study_id>
    <nct_id>NCT01668706</nct_id>
  </id_info>
  <brief_title>Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts</brief_title>
  <official_title>Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid 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>
      Opioid abuse is a complex problem, which not only impacts on addicts' physical and&#xD;
      psychological health individually, but also threats the society. Recently, spread of HIV via&#xD;
      sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious&#xD;
      public health problem all over the world. In Taiwan, since the first HIV-infected IDU&#xD;
      identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the&#xD;
      epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with&#xD;
      Department of Justice and implemented harm reduction programs in 2005. It is the milestone&#xD;
      that opioid addiction is officially treated as a health rather than a legal issue in Taiwan.&#xD;
      Among the harm reduction programs of needle and syringe exchange for IDUs as well as&#xD;
      substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one of&#xD;
      the most important parts. Till 2008, there were over 13,000 heroin addicts participated in&#xD;
      more than 80 MMT programs.&#xD;
&#xD;
      Although the clinical evidences have proven the superior effectiveness of maintenance therapy&#xD;
      in ameliorating illicit substances abuse, decreasing criminality and improving quality of&#xD;
      life, there are common problems of sleep disturbance and neurocognitive impairments among the&#xD;
      subjects receiving opioid medications. The concerns of the adverse effects might thus&#xD;
      frustrate the subjects' motivation and compliance to maintain treatments. However, sleep&#xD;
      disturbance and neurocognitive impairments related to opioid medications are often neglected&#xD;
      in the clinical practices and there are scanty researches focusing on these crucial issues in&#xD;
      the existing literature.&#xD;
&#xD;
      In this prospective study, four groups of subjects including methadone maintenance treatment,&#xD;
      buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers will be&#xD;
      enrolled. Via the comprehensive assessments including clinical interview, neurocognitive&#xD;
      examinations, electrocardiogram-based sleep breathing detector and pharmacogenomical&#xD;
      evaluation, we will not only have the opportunities to have more insights on the impacts of&#xD;
      opioid medications on sleep and neurocognitive performances, but also develop more adequate&#xD;
      strategies to improve motivation and outcome in treating the opioid addicts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Group differences in demopraphics</measure>
    <time_frame>one year</time_frame>
    <description>support system, vital sign, substance use history</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gruop differences in neuro-cognitive functions</measure>
    <time_frame>one year</time_frame>
    <description>attention, executive function, decision making</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">340</enrollment>
  <condition>Heroin Dependence</condition>
  <arm_group>
    <arm_group_label>Methadone maintenance treatment (MMT)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Buprenorphine-Naloxone treatment (BNT)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Medication-free ex-addicts(MF)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal control (NC)</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma, DNA and urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Normal control group:&#xD;
&#xD;
             Healthy adults will be recruited from community.&#xD;
&#xD;
          2. Methadone Maintenance treatment group Study subjects will be enrolled only in the&#xD;
             methadone clinic.&#xD;
&#xD;
          3. Buprenorphine/Naloxone treatment group Subjects will be enrolled only in the clinic.&#xD;
&#xD;
          4. Drug-free ex-addict group Subjects will be recruited from the therapeutic communities&#xD;
             and halfway house of Operation Dawn.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Normal control group (NC):&#xD;
&#xD;
             Inclusion criteria:&#xD;
&#xD;
               1. Chinese ethnicity&#xD;
&#xD;
               2. Men or women above age of 20&#xD;
&#xD;
               3. Able to participate in a clinical assessment in Chinese (including Mandarin and&#xD;
                  Taiwanese dialects)&#xD;
&#xD;
               4. Individuals who have completed a written consent form&#xD;
&#xD;
             Exclusion criteria:&#xD;
&#xD;
               1. Patients with comorbid severe mental disorders including:&#xD;
&#xD;
                    1. Organic mental disorders, or&#xD;
&#xD;
                    2. Schizophrenia&#xD;
&#xD;
               2. Past diagnosis of Heroin dependence by DSM-IV definition&#xD;
&#xD;
               3. Severe cognitive impairment&#xD;
&#xD;
               4. Being pregnant&#xD;
&#xD;
          2. Methadone maintenance treatment group (MMT)&#xD;
&#xD;
             Inclusion criteria:&#xD;
&#xD;
               1. Chinese ethnicity&#xD;
&#xD;
               2. Men or women above age of 20, below age of 65&#xD;
&#xD;
               3. Able to participate in a clinical assessment in Chinese (including Mandarin and&#xD;
                  Taiwanese dialects)&#xD;
&#xD;
               4. Diagnosis of Heroin dependence by DSM-IV definition&#xD;
&#xD;
               5. Enter methadone maintenance therapy for at least 3 months&#xD;
&#xD;
               6. No change of methadone dosage for the last week&#xD;
&#xD;
               7. Regularly took methadone for the last week&#xD;
&#xD;
               8. Individuals who have completed a written consent form&#xD;
&#xD;
             Exclusion criteria:&#xD;
&#xD;
               1. Patients with comorbid severe mental disorders including:&#xD;
&#xD;
                    1. Organic mental disorders, or&#xD;
&#xD;
                    2. Schizophrenia&#xD;
&#xD;
               2. Severe cognitive impairment&#xD;
&#xD;
               3. Being pregnant&#xD;
&#xD;
          3. Buprenorphine/Naloxone treatment group (BNT)&#xD;
&#xD;
             Inclusion criteria:&#xD;
&#xD;
               1. Chinese ethnicity&#xD;
&#xD;
               2. Men or women above age of 20, below age of 65&#xD;
&#xD;
               3. Able to participate in a clinical assessment in Chinese (including Mandarin and&#xD;
                  Taiwanese dialects)&#xD;
&#xD;
               4. Diagnosis of Heroin dependence by DSM-IV definition&#xD;
&#xD;
               5. Enter buprenorphine maintenance therapy for at least 3 months&#xD;
&#xD;
               6. No change of buprenorphine dosage for the last week&#xD;
&#xD;
               7. Regularly took buprenorphine for the last week&#xD;
&#xD;
               8. Individuals who have completed a written consent form&#xD;
&#xD;
             Exclusion criteria:&#xD;
&#xD;
               1. Patients with comorbid severe mental disorders including:&#xD;
&#xD;
                    1. Organic mental disorders, or&#xD;
&#xD;
                    2. Schizophrenia&#xD;
&#xD;
               2. Severe cognitive impairment&#xD;
&#xD;
               3. Being pregnant&#xD;
&#xD;
          4. Medication-free ex-addict group (MF)&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          1. Chinese ethnicity&#xD;
&#xD;
          2. Men or women above age of 20&#xD;
&#xD;
          3. Able to participate in a clinical assessment in Chinese (including Mandarin and&#xD;
             Taiwanese dialects)&#xD;
&#xD;
          4. Diagnosis of Heroin dependence by DSM-IV definition&#xD;
&#xD;
          5. Individuals who have completed a written consent form&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients with comorbid severe mental disorders including:&#xD;
&#xD;
               1. Organic mental disorders, or&#xD;
&#xD;
               2. Schizophrenia&#xD;
&#xD;
          2. Severe cognitive impairment&#xD;
&#xD;
          3. Being pregnant&#xD;
&#xD;
          4. Exposure of methadone, buprenorphine and other opioid treatment in the previous 3&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheng-Chang Wang, M.D., M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Health Research Institutes, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ChangHua Christian Hospital</name>
      <address>
        <city>Lukang</city>
        <state>ChangHua</state>
        <zip>50550</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei City</state>
        <zip>22060</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22060</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>En-Chu-Gong Hospital</name>
      <address>
        <city>Sanxia</city>
        <state>New Taipei</state>
        <zip>23702</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Health Research Institute</name>
      <address>
        <city>Miaoli County</city>
        <zip>35053</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>November 8, 2016</last_update_submitted>
  <last_update_submitted_qc>November 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2016</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>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <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/NCT01668706
org study id: MD098SCW01
nct id: NCT01668706
lead sponsor: 
has dmc: No
Opioid abuse is a complex problem, which not only impacts on addicts' physical and
      psychological health individually, but also threats the society. Recently, spread of HIV via
      sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious
      public health problem all over the world. In Taiwan, since the first HIV-infected IDU
      identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the
      epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with
      Department of Justice and implemented harm reduction programs in 2005. It is the milestone
      that opioid addiction is officially treated as a health rather than a legal issue in Taiwan.
      Among the harm reduction programs of needle and syringe exchange for IDUs as well as
      substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one of
      the most important parts. Till 2008, there were over 13,000 heroin addicts participated in
      more than 80 MMT programs.

      Although the clinical evidences have proven the superior effectiveness of maintenance therapy
      in ameliorating illicit substances abuse, decreasing criminality and improving quality of
      life, there are common problems of sleep disturbance and neurocognitive impairments among the
      subjects receiving opioid medications. The concerns of the adverse effects might thus
      frustrate the subjects' motivation and compliance to maintain treatments. However, sleep
      disturbance and neurocognitive impairments related to opioid medications are often neglected
      in the clinical practices and there are scanty researches focusing on these crucial issues in
      the existing literature.

      In this prospective study, four groups of subjects including methadone maintenance treatment,
      buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers will be
      enrolled. Via the comprehensive assessments including clinical interview, neurocognitive
      examinations, electrocardiogram-based sleep breathing detector and pharmacogenomical
      evaluation, we will not only have the opportunities to have more insights on the impacts of
      opioid medications on sleep and neurocognitive performances, but also develop more adequate
      strategies to improve motivation and outcome in treating the opioid addicts.
observational model: Cohort
time perspective: Prospective
measure: Group differences in demopraphics
time frame: one year
description: support system, vital sign, substance use history
measure: Gruop differences in neuro-cognitive functions
time frame: one year
description: attention, executive function, decision making
arm group label: Methadone maintenance treatment (MMT)
arm group label: Buprenorphine-Naloxone treatment (BNT)
arm group label: Medication-free ex-addicts(MF)
arm group label: Normal control (NC)
plasma, DNA and urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sheng-Chang Wang, M.D., M.Sc.
role: Principal Investigator
affiliation: National Health Research Institutes, Taiwan
facility: 
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Heroin Dependence