<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2015022821273N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-04</date_registration>
      <primary_sponsor>Yazd University of Medical Science</primary_sponsor>
      <public_title>Effect of the brain stimulation with  very weak electrical current in opiod addiction</public_title>
      <acronym>tDCS-UROD</acronym>
      <scientific_title>Transcranial direct current stimulation effects on the treatment of the opiate addiction in Ultra rapid opioid detoxification method</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18677</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>opiod addiction.</hc_freetext>
      <i_freetext>Intervention 1: intervention group:We will apply real mode of tDCS once a day for three successive sessions.  anodal electrode  will locate on the right dorsolateral prefrontal cortex(DLPFC) and cathode on the left one. The intensity of electrical current is 2mA for 20 minutes through each session. Direct current will be transferred by using a saline-soaked pair of surface sponge. Intervention 2: control group:We will apply sham mode of tDCS once a day for three successive sessions.  anodal electrode will locate on the right dorsolateral prefrontal cortex(DLPFC) and cathode on the left one.Since the study is double blind,device will remain for20 minutes. The intensity of electrical current is 2mA for 30 seconds through each session and then the device will be put out. Direct current will be transferred by using a saline-soaked pair of surface sponge.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Mirhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesia department, Paramedical  institue, Imam Hossein square, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916188635</zip>
        <telephone>+98 35 3624 5956</telephone>
        <email>mirhosseini@tabrizu.ac.ir mirhoseini.h@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Mirhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesia department, Paramedical  institue, Imam Hossein square, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916188635</zip>
        <telephone>+98 35 3624 5956</telephone>
        <email>mirhosseini@tabrizu.ac.ir mirhoseini.h@gmail.com</email>
        <affiliation>Yazd Medical science University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Diagnostic criteria for opiate dependence defined by Diagnostic and Statistical Manual of Mental Disorders (4th ed.) (DSM-IV);&#13;
Inhalational  application route;Literate; last usage at the night before;male gender Exclusion criteria: Siezure or any history of convulsion which has been prohibited for tDCS;Cardiopulmomary or Hepatic diease or any sensitivity to anesthetics which have been prohibited for general anesthesia; Comorbidy of other psychiatric disorders such as psychosis,anxiety,mood and affective disorder;Amphetamine,Alcohol and sedatives abuse</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z71.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drug abuse counselling and surveillance</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group:We will apply real mode of tDCS once a day for three successive sessions.  anodal electrode  will locate on the right dorsolateral prefrontal cortex(DLPFC) and cathode on the left one. The intensity of electrical current is 2mA for 20 minutes through each session. Direct current will be transferred by using a saline-soaked pair of surface sponge</i_keyword>
      <i_keyword>control group:We will apply sham mode of tDCS once a day for three successive sessions.  anodal electrode will locate on the right dorsolateral prefrontal cortex(DLPFC) and cathode on the left one.Since the study is double blind,device will remain for20 minutes. The intensity of electrical current is 2mA for 30 seconds through each session and then the device will be put out. Direct current will be transferred by using a saline-soaked pair of surface sponge</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Craving. Timepoint: before,afte rand 1,3,12hrs and 2weeks,1,3months after treatment. Method of measurement: DDQ questionary.</prim_outcome>
      <prim_outcome>Withdrawal syndrom. Timepoint: before,afte rand 1,3,12hrs and 2weeks,1,3months after treatment. Method of measurement: OOWS questionary.</prim_outcome>
      <prim_outcome>Relapse. Timepoint: 2 weeks,1 &amp; 3 months after treatment. Method of measurement: Interviews &amp; Urine  strip test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Irritation of electrode location. Timepoint: after the last intervention. Method of measurement: observation.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-02</approval_date>
        <contact_name>Yazd University of medical science</contact_name>
        <contact_address>Headquarters of  University, Bahonar square, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
