<?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>IRCT2012062910133N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-22</date_registration>
      <primary_sponsor>Loghman-Hakim Toxicological Reserch Center dependent to Shahid-Beheshti University</primary_sponsor>
      <public_title>The role of  naltrexone in opioid toxicity</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of oral naltrexone to maintain normal ventilation after acute methadone Poisoning in Opioid non-dependent  Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10598</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>Acute Opioids Toxicity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group;&#13;
After emergency management (if needed) the patients in intervention group will take a single dose of 50mg naltrexone orally . During the hospital stay, the prevalence of respiratory depression or respiratory arrest, and loss of consciousness will be assess in these patients  hourly by physical examination and monitoring of oxygenation and CO2 pressure of the blood (based on arterial blood gases analysis), and the O2 saturation by pulse oxymetery. Intervention 2: Control group;&#13;
The patients in control group after emergency management (if needed) will take a placebo drug. These patient during hospital admission will monitor regarding to respiratory depression or arrest and loss of consciousness by hourly physical examination, arterial Pco2 and oxygenation by arterial blood gas and pulseoxymetery respectively.</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>Hosein Hassanian-Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poisoning Ward- Loghamn-Hakim Hospital, Kamali Ave,. Makhsus Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5540 9534</telephone>
        <email>hassanian@sbmu.ac.ir/hasanian2000@yahoo.comaghabikloo@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Aghabiklooei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poisoning Ward- Loghman-Hakim Hospital, Kamali Ave., Makhsus Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13336-31151</zip>
        <telephone>+98 21 5540 9534</telephone>
        <email>aghabikloo@yahoo.com;aghabeikloo@tums.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
The acutely methadone-poisoned patients ;opioid non-dependent patients;&#13;
&#13;
Exclusion criteria:&#13;
The addicted patients (Opioid-dependent patients); Active liver disease; Acute methadone poisoning with development of complications (aspiration pneumonia, brain trauma, and cardiogenic or non-cardiogenic pulmonary edema); History of acute coronory syndrome in last 3 weeks</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of opioids</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group;&#13;
After emergency management (if needed) the patients in intervention group will take a single dose of 50mg naltrexone orally . During the hospital stay, the prevalence of respiratory depression or respiratory arrest, and loss of consciousness will be assess in these patients  hourly by physical examination and monitoring of oxygenation and CO2 pressure of the blood (based on arterial blood gases analysis), and the O2 saturation by pulse oxymetery.</i_keyword>
      <i_keyword>Control group;&#13;
The patients in control group after emergency management (if needed) will take a placebo drug. These patient during hospital admission will monitor regarding to respiratory depression or arrest and loss of consciousness by hourly physical examination, arterial Pco2 and oxygenation by arterial blood gas and pulseoxymetery respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oxygenation (Arterial Blood Oxygen Saturation in Percent). Timepoint: Continuously up to 48 hours. Method of measurement: Pulseoxymetery.</prim_outcome>
      <prim_outcome>Ventilation status. Timepoint: every 6 hours up to 48 hours. Method of measurement: Arterial or venous blood gas.</prim_outcome>
      <prim_outcome>Hospital Stay. Timepoint: Hours. Method of measurement: Based on registration of time and date on medical file.</prim_outcome>
      <prim_outcome>Acute Complications. Timepoint: Up to 48  hours. Method of measurement: Physical Examination, inspection and paraclinic data.</prim_outcome>
      <prim_outcome>Respiratory rate per minute. Timepoint: hour to hour up to 48 hours. Method of measurement: physical examination and inspection.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of Consciousness. Timepoint: hour to hour Up to 48 hours. Method of measurement: Physical Examination and assessment of neurologic system.</sec_outcome>
      <sec_outcome>Need to naloxone. Timepoint: During 48 hrs admission. Method of measurement: Dose of Naloxone Received (mg).</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>Loghman-Hakim Toxicological Reserch Center dependent to Shahid-Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-16</approval_date>
        <contact_name>Shahid Beheshti Medical University</contact_name>
        <contact_address>Velenjak, Next to Taleghani Hospital Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
