<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/NCT03012373</url>
  </required_header>
  <id_info>
    <org_study_id>LuTungCH-1</org_study_id>
    <nct_id>NCT03012373</nct_id>
  </id_info>
  <brief_title>Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts</brief_title>
  <acronym>AAMTH</acronym>
  <official_title>Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lu-Tung Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lu-Tung Christian Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of&#xD;
      efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy&#xD;
      both combined with methadone treatment services for heroin addicts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methadone substitution therapy has been the treatment of first choice for opiate dependence,&#xD;
      but patient on Methadone substitution therapy report a wide side effects, and relapse rate is&#xD;
      up to two third of methadone treatment patients between one to two years. Therefore, adjuvant&#xD;
      therapeutic interventions for heroin addiction patients are needed. Since 1996, the World&#xD;
      Health Organization (WHO) has classified acupuncture treatment indications, including drug&#xD;
      abuse. The purpose of this study is to compare the difference of efficacy between ear&#xD;
      acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with&#xD;
      standard methadone maintenance therapy to the heroin addicts.&#xD;
&#xD;
      Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20)&#xD;
      receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week&#xD;
      wash-out period. Then ear acupressure alone for another four weeks.&#xD;
&#xD;
      Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week&#xD;
      wash-out period, then ear acupressure combined with electroacupuncture for another four&#xD;
      weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess&#xD;
      the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the&#xD;
      Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep&#xD;
      quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine&#xD;
      opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of&#xD;
      treatment, to screen opiate reuse.&#xD;
&#xD;
      The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon&#xD;
      craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality&#xD;
      when provided as an adjunct to a standard methadone maintenance treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">May 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessed the change of opioid craving</measure>
    <time_frame>Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment</time_frame>
    <description>opioid craving scores on the Visual Analog Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessed the change of life quality</measure>
    <time_frame>Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment</time_frame>
    <description>Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessed the change of emotion problem</measure>
    <time_frame>Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment</time_frame>
    <description>Emotion problems was evaluated by Beck anxiety and Depression inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opiate usage</measure>
    <time_frame>Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment</time_frame>
    <description>Use urine test to detect opiate use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessed the change of sleep quality</measure>
    <time_frame>Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment</time_frame>
    <description>Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Opiate Withdrawal Syndrome</condition>
  <arm_group>
    <arm_group_label>Ear acupressure &amp; Electroacupuncture (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ear acupressure &amp; Electroacupuncture (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ear acupressure alone</intervention_name>
    <description>The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes then were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.</description>
    <arm_group_label>Ear acupressure &amp; Electroacupuncture (A)</arm_group_label>
    <arm_group_label>Ear acupressure &amp; Electroacupuncture (B)</arm_group_label>
    <other_name>Auricular acupressure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture plus ear acupressure</intervention_name>
    <description>Acupuncture included Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation was conducted. The frequency of electrical stimulation was 5 Hz and wave form was adjustable. The intensities of the stimulation were increased in 1 mA increments to maximal tolerable intensity. At the same time, The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes. After 15 minutes treatment, acupuncture needles were removed and magnet pellets were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.</description>
    <arm_group_label>Ear acupressure &amp; Electroacupuncture (A)</arm_group_label>
    <arm_group_label>Ear acupressure &amp; Electroacupuncture (B)</arm_group_label>
    <other_name>Electric acupuncture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for&#xD;
        Opioid Use Disorder and had been received methadone maintenance treatment for more then one&#xD;
        month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. had taking acupuncture treatment in past 30 days&#xD;
&#xD;
          2. had severe adverse effects or events history from receiving acupuncture treatment&#xD;
&#xD;
          3. had any serious physical illness&#xD;
&#xD;
          4. had a significant risk of suicide&#xD;
&#xD;
          5. ear infection&#xD;
&#xD;
          6. were pregnant or or a woman plan to pregnant&#xD;
&#xD;
          7. had bleeding disorders or were taking anticoagulant drugs&#xD;
&#xD;
          8. had epilepsy, cerebral vascular disease and brain injured history.&#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>Wen-Chen Ouyang, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lu-Tung Christian Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lu-Tung Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <zip>505</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://store.samhsa.gov/product/TIP-45-Detoxification-and-Substance-Abuse-Treatment/SMA15-4131</url>
    <description>Detoxification and Substance Abuse Treatment.</description>
  </link>
  <reference>
    <citation>Chan YY, Lo WY, Li TC, Shen LJ, Yang SN, Chen YH, Lin JG. Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. Am J Chin Med. 2014;42(3):569-86. doi: 10.1142/S0192415X14500372.</citation>
    <PMID>24871652</PMID>
  </reference>
  <reference>
    <citation>Lin JG, Chan YY, Chen YH. Acupuncture for the treatment of opiate addiction. Evid Based Complement Alternat Med. 2012;2012:739045. doi: 10.1155/2012/739045. Epub 2012 Feb 22.</citation>
    <PMID>22474521</PMID>
  </reference>
  <reference>
    <citation>Boyuan Z, Yang C, Ke C, Xueyong S, Sheng L. Efficacy of acupuncture for psychological symptoms associated with opioid addiction: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:313549. doi: 10.1155/2014/313549. Epub 2014 Nov 4.</citation>
    <PMID>25530779</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lu-Tung Christian Hospital</investigator_affiliation>
    <investigator_full_name>Wen-Chen Ouyang</investigator_full_name>
    <investigator_title>Superintendent</investigator_title>
  </responsible_party>
  <keyword>methadone</keyword>
  <keyword>heroin</keyword>
  <keyword>acupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03012373
org study id: LuTungCH-1
nct id: NCT03012373
lead sponsor: 
has dmc: Yes
This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of
      efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy
      both combined with methadone treatment services for heroin addicts.
Methadone substitution therapy has been the treatment of first choice for opiate dependence,
      but patient on Methadone substitution therapy report a wide side effects, and relapse rate is
      up to two third of methadone treatment patients between one to two years. Therefore, adjuvant
      therapeutic interventions for heroin addiction patients are needed. Since 1996, the World
      Health Organization (WHO) has classified acupuncture treatment indications, including drug
      abuse. The purpose of this study is to compare the difference of efficacy between ear
      acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with
      standard methadone maintenance therapy to the heroin addicts.

      Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20)
      receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week
      wash-out period. Then ear acupressure alone for another four weeks.

      Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week
      wash-out period, then ear acupressure combined with electroacupuncture for another four
      weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess
      the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the
      Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep
      quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine
      opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of
      treatment, to screen opiate reuse.

      The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon
      craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality
      when provided as an adjunct to a standard methadone maintenance treatment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessed the change of opioid craving
time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
description: opioid craving scores on the Visual Analog Scale
measure: Assessed the change of life quality
time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
description: Life quality was assessed using the Taiwanese version of Short Form 36 (SF-36)
measure: Assessed the change of emotion problem
time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
description: Emotion problems was evaluated by Beck anxiety and Depression inventory
measure: Opiate usage
time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
description: Use urine test to detect opiate use
measure: Assessed the change of sleep quality
time frame: Four weeks after first phase treatment/ one weeks after washout period/ four weeks after second phase treatment
description: Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
arm group label: Ear acupressure & Electroacupuncture (A)
arm group type: Experimental
description: Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.
arm group label: Ear acupressure & Electroacupuncture (B)
arm group type: Experimental
description: Electroacupuncture plus Ear acupressure or Ear acupressure alone for four weeks followed by an one week wash-out period. Then with crossover to the othe.
intervention type: Procedure
intervention name: Ear acupressure alone
description: The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes then were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
arm group label: Ear acupressure & Electroacupuncture (A)
arm group label: Ear acupressure & Electroacupuncture (B)
other name: Auricular acupressure
intervention type: Procedure
intervention name: Electroacupuncture plus ear acupressure
description: Acupuncture included Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation was conducted. The frequency of electrical stimulation was 5 Hz and wave form was adjustable. The intensities of the stimulation were increased in 1 mA increments to maximal tolerable intensity. At the same time, The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes. After 15 minutes treatment, acupuncture needles were removed and magnet pellets were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
arm group label: Ear acupressure & Electroacupuncture (A)
arm group label: Ear acupressure & Electroacupuncture (B)
other name: Electric acupuncture
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wen-Chen Ouyang, Ph.D.
role: Principal Investigator
affiliation: Lu-Tung Christian Hospital
facility: 
country: Taiwan
url: http://store.samhsa.gov/product/TIP-45-Detoxification-and-Substance-Abuse-Treatment/SMA15-4131
description: Detoxification and Substance Abuse Treatment.
citation: Chan YY, Lo WY, Li TC, Shen LJ, Yang SN, Chen YH, Lin JG. Clinical efficacy of acupuncture as an adjunct to methadone treatment services for heroin addicts: a randomized controlled trial. Am J Chin Med. 2014;42(3):569-86. doi: 10.1142/S0192415X14500372.
PMID: 24871652
citation: Lin JG, Chan YY, Chen YH. Acupuncture for the treatment of opiate addiction. Evid Based Complement Alternat Med. 2012;2012:739045. doi: 10.1155/2012/739045. Epub 2012 Feb 22.
PMID: 22474521
citation: Boyuan Z, Yang C, Ke C, Xueyong S, Sheng L. Efficacy of acupuncture for psychological symptoms associated with opioid addiction: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:313549. doi: 10.1155/2014/313549. Epub 2014 Nov 4.
PMID: 25530779
responsible party type: Principal Investigator
investigator affiliation: Lu-Tung Christian Hospital
investigator full name: Wen-Chen Ouyang
investigator title: Superintendent
mesh term: Substance Withdrawal Syndrome
sharing ipd: Undecided