<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/NCT03010761</url>
  </required_header>
  <id_info>
    <org_study_id>C103RE1059</org_study_id>
    <nct_id>NCT03010761</nct_id>
  </id_info>
  <brief_title>Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer</brief_title>
  <official_title>Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      No medication existed for BQ dependence. No clinical trials existed for the drug therapy.&#xD;
      Previous study showed that BQ possessed the antidepressant effect via pathway of monoamine&#xD;
      oxidase A (MAO-A). An animal model also found that the arecoline from BQ has a property as&#xD;
      MAO-A inhibitor. Therefore, the investigators hypothesized that inhibition of the MAO-A or&#xD;
      antidepressants might reduce the BQ addiction severity.&#xD;
&#xD;
      The investigators will conduct the randomization and double blinded with placebo controlled&#xD;
      study with 90 participants with BQ dependence from the Family Medicine and ear, nose, and&#xD;
      throat (ENT) outpatient department (OPD). All participants shall agree the informed consent.&#xD;
      The range of age is from 18 to 65 years old. The participants are diagnosed as BQ use&#xD;
      disorder without other psychiatry co-morbidity, according to the Diagnostic and Statistical&#xD;
      Manual (DSM)-V criteria. Those who have severe physical illness, psychiatric illness, and&#xD;
      other substance use disorder except cigarettes are excluded. All participants receive the&#xD;
      semi-structure interview by DSM-V, International Classification of Diseases (ICD)-10, and&#xD;
      Mini International Neuropsychiatric Interview by the psychiatrist. Before the intervention,&#xD;
      the participants will finish their basic data, daily amount of cigarettes, betel nut, medical&#xD;
      history and psycho-social rating scales. Next, in addition to counseling, the investigators&#xD;
      will continue or modify the optimal antidepressants based on the previous results.&#xD;
&#xD;
      The investigators will evaluate their BQ use condition as what has been measured in the&#xD;
      natural observation study of the first year. The investigators will check the outcome&#xD;
      measurement by visual analog scale, betel quid withdrawal severity scale, Yale-Brown&#xD;
      Obsessive-Compulsive (Y-BOCS) - betel quid (BQ) scale. The investigators also followed their&#xD;
      hamilton depression scale; Beck depression index; and Beck anxiety index in the baseline,&#xD;
      2nd, 4th, 6th , and 8th week. The investigators also obtained the participants' gene type if&#xD;
      the participants also agree for the prediction of oral cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We'll conduct the betel-quid (BQ) dependence clinical trial since 2016. Eligible cases will&#xD;
      be enrolled for the following 8 week double-blinded placebo controlled trial. The groups will&#xD;
      be divided into three groups. Outcome measures include BQ use condition, addiction severity&#xD;
      rating scale, emotional rating scale including Beck Anxiety Index (BAI), Beck Depression&#xD;
      Index (BDI), Hamilton Depression Scales (HAMDs), and urine BQ metabolites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    all participants finished the trial&#xD;
  </why_stopped>
  <start_date type="Actual">January 14, 2016</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>betelnut use severity rating scale for addiction severity of betelnut</measure>
    <time_frame>8 weeks</time_frame>
    <description>The betelnut severity rating scale is a questionnaire rated by the psychiatrist or trained psychologist/nurse, containing 21 yes or no questions about betelnut use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Rating Scale for depression</measure>
    <time_frame>8 weeks</time_frame>
    <description>for depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace&amp; Company)</measure>
    <time_frame>8 weeks</time_frame>
    <description>self-rating for depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace&amp; Company)</measure>
    <time_frame>8 weeks</time_frame>
    <description>self-rating for anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>betelnut use Yale-Brown Obsessive Compulsive Disorder-like Scale for the craving status</measure>
    <time_frame>8 weeks</time_frame>
    <description>Yale-Brown Obsessive Compulsive Disorder-like Scale, translated in Chinese and betelnut use craving form, a questionnaires containing 10 questions rated by the psychiatrist or trained psychologist/nurse, severity from 0-4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>betelnut metabolites urinary analysis</measure>
    <time_frame>8 weeks</time_frame>
    <description>arecoline, arecaidine, and N-methylnipecotic acid checked by liquid chromatography mass spectrometry (LC-MS)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Addiction</condition>
  <arm_group>
    <arm_group_label>medication pills 1: escitalopram 10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10mg once daily, 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>medication pills 2: moclobemide 150mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150mg once daily, 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>medication pills 3: Placebo - Cap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>placebo once daily, 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>escitalopram</intervention_name>
    <description>antidepressant use for the betel-quid abstinence</description>
    <arm_group_label>medication pills 1: escitalopram 10mg</arm_group_label>
    <other_name>Lexapro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moclobemide</intervention_name>
    <description>antidepressant use for the betel-quid abstinence</description>
    <arm_group_label>medication pills 2: moclobemide 150mg</arm_group_label>
    <other_name>yutac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - Cap</intervention_name>
    <description>Placebo - Cap</description>
    <arm_group_label>medication pills 3: Placebo - Cap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-V criteria suitable for betelnut use disorder&#xD;
&#xD;
          -  No severe physical disorder&#xD;
&#xD;
          -  No major psychiatric illness&#xD;
&#xD;
          -  Chinese Speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe physical disorder&#xD;
&#xD;
          -  Major psychiatric illness&#xD;
&#xD;
          -  Inability to understand the whole protocol&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ko Ying-Chin, PHD</last_name>
    <role>Study Director</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>addiction</keyword>
  <keyword>betel-quid</keyword>
  <keyword>drug therapy</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moclobemide</mesh_term>
    <mesh_term>Escitalopram</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 23, 2019</submitted>
    <returned>September 26, 2019</returned>
    <submitted>February 9, 2020</submitted>
    <returned>February 19, 2020</returned>
  </pending_results>
  <!-- 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/NCT03010761
org study id: C103RE1059
nct id: NCT03010761
lead sponsor: 
has dmc: Yes
No medication existed for BQ dependence. No clinical trials existed for the drug therapy.
      Previous study showed that BQ possessed the antidepressant effect via pathway of monoamine
      oxidase A (MAO-A). An animal model also found that the arecoline from BQ has a property as
      MAO-A inhibitor. Therefore, the investigators hypothesized that inhibition of the MAO-A or
      antidepressants might reduce the BQ addiction severity.

      The investigators will conduct the randomization and double blinded with placebo controlled
      study with 90 participants with BQ dependence from the Family Medicine and ear, nose, and
      throat (ENT) outpatient department (OPD). All participants shall agree the informed consent.
      The range of age is from 18 to 65 years old. The participants are diagnosed as BQ use
      disorder without other psychiatry co-morbidity, according to the Diagnostic and Statistical
      Manual (DSM)-V criteria. Those who have severe physical illness, psychiatric illness, and
      other substance use disorder except cigarettes are excluded. All participants receive the
      semi-structure interview by DSM-V, International Classification of Diseases (ICD)-10, and
      Mini International Neuropsychiatric Interview by the psychiatrist. Before the intervention,
      the participants will finish their basic data, daily amount of cigarettes, betel nut, medical
      history and psycho-social rating scales. Next, in addition to counseling, the investigators
      will continue or modify the optimal antidepressants based on the previous results.

      The investigators will evaluate their BQ use condition as what has been measured in the
      natural observation study of the first year. The investigators will check the outcome
      measurement by visual analog scale, betel quid withdrawal severity scale, Yale-Brown
      Obsessive-Compulsive (Y-BOCS) - betel quid (BQ) scale. The investigators also followed their
      hamilton depression scale; Beck depression index; and Beck anxiety index in the baseline,
      2nd, 4th, 6th , and 8th week. The investigators also obtained the participants' gene type if
      the participants also agree for the prediction of oral cancers.
We'll conduct the betel-quid (BQ) dependence clinical trial since 2016. Eligible cases will
      be enrolled for the following 8 week double-blinded placebo controlled trial. The groups will
      be divided into three groups. Outcome measures include BQ use condition, addiction severity
      rating scale, emotional rating scale including Beck Anxiety Index (BAI), Beck Depression
      Index (BDI), Hamilton Depression Scales (HAMDs), and urine BQ metabolites.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: betelnut use severity rating scale for addiction severity of betelnut
time frame: 8 weeks
description: The betelnut severity rating scale is a questionnaire rated by the psychiatrist or trained psychologist/nurse, containing 21 yes or no questions about betelnut use
measure: Hamilton Depression Rating Scale for depression
time frame: 8 weeks
description: for depression
measure: Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
time frame: 8 weeks
description: self-rating for depression
measure: Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
time frame: 8 weeks
description: self-rating for anxiety
measure: betelnut use Yale-Brown Obsessive Compulsive Disorder-like Scale for the craving status
time frame: 8 weeks
description: Yale-Brown Obsessive Compulsive Disorder-like Scale, translated in Chinese and betelnut use craving form, a questionnaires containing 10 questions rated by the psychiatrist or trained psychologist/nurse, severity from 0-4
measure: betelnut metabolites urinary analysis
time frame: 8 weeks
description: arecoline, arecaidine, and N-methylnipecotic acid checked by liquid chromatography mass spectrometry (LC-MS)
arm group label: medication pills 1: escitalopram 10mg
arm group type: Experimental
description: 10mg once daily, 8 weeks
arm group label: medication pills 2: moclobemide 150mg
arm group type: Experimental
description: 150mg once daily, 8 weeks
arm group label: medication pills 3: Placebo - Cap
arm group type: Experimental
description: placebo once daily, 8 weeks
intervention type: Drug
intervention name: escitalopram
description: antidepressant use for the betel-quid abstinence
arm group label: medication pills 1: escitalopram 10mg
other name: Lexapro
intervention type: Drug
intervention name: Moclobemide
description: antidepressant use for the betel-quid abstinence
arm group label: medication pills 2: moclobemide 150mg
other name: yutac
intervention type: Drug
intervention name: Placebo - Cap
description: Placebo - Cap
arm group label: medication pills 3: Placebo - Cap
criteria: 
gender: Male
minimum age: 14 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ko Ying-Chin, PHD
role: Study Director
affiliation: China Medical University Hospital
responsible party type: Sponsor
mesh term: Behavior, Addictive
mesh term: Moclobemide
mesh term: Escitalopram
sharing ipd: Yes
submitted: August 23, 2019
returned: September 26, 2019
submitted: February 9, 2020
returned: February 19, 2020