<?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>IRCT138706121187N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-01-09</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Pattern of Opioid Withdrawal Signs and Symptoms in Three Groups</public_title>
      <acronym></acronym>
      <scientific_title>The Pattern of Opioid Withdrawal Signs and Symptoms in Three Groups: 1. Patients undergoing Clonidine Abstinence Therapy, 2. Patients on starting clinical dose of Methadone Maintenance Therapy (MMT), and 3. Patients admitted for short-time detoxification with Methadone in Opioid Addict Subjects who were Referred to Imam-Reza Hospital Rehabilitation Center and Toxicology Ward – Mashhad from November 2008 to October 2009</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/387</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Opioid Addiction.</hc_freetext>
      <i_freetext>Intervention 1: In the first group, patients are given Clonidine 0.1 mg per oral q 12 hours, Benzodiazepine (Chlorodiazepoxide 10mg at 6 Am, 10 mg at 2 Pm and 20 mg at 10 Pm per oral), Indomethacin 100 mg if necessary, Omeprazole 1 mg per oral before eating breakfast, Ibuprofen 400 mg q 12 hours per oral, with Risperidone 1 mg daily, and with or without Gabapentin and if needed Serum and Vitamin C in a 10 day period of time. Intervention 2: Patients on Methadone Maintenance Therapy (MMT) for 45 days, are given Methadone 40 mg per oral in the first day and then this dose will be increased 5 mg daily for disappearing the withdrawal signs and symptoms at most until the 10th day and then this dose will gradually be reduced to zero until the end of the 45 day period, pain killer (NSAIDs (Indomethacin 100 mg if necessary) ) in the first ten days and also MOM syrup 10 cc q 8 hours per oral. Intervention 3: The patients in the third group, are given Methadone 10 mg in the first day, 5 mg in the second and third day and nothing in the forth and fifth day, and also Maintenance serum of ⅓⅔ 2 Lit daily IV if necessary,Clonidine 0.1 mg per oral q 12 hours, Chlorodiazepoxide 10mg at 6 Am, 10 mg at 2 Pm and 20 mg at 10 Pm per oral, Indomethacin 100 mg if necessary, Omeprazole 1 mg per oral before eating breakfast, Ibuprofen 400 mg q 12 hours per oral, with Risperidone 1 mg daily.</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>Dr. Reza Afshari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam-Reza Hospital Toxicology Ward ,Medical Toxicology Research Center – Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 1859 8973</telephone>
        <email>afsharir@mums.ac.ir,javidida811@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Javidi D. B.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam-Reza University Hospital  Transplantation Ward – Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 1881 2750</telephone>
        <email>a_javidi@hotmail.com,javidida811@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: will to enter the study,  Having no positive history of a psychological disorder, Not using any psychological either neurological drugs, Having no positive history of a cardiovascular disease, Being male, age between 18 to 60 years old&#13;
Exclusion criteria: Discontinuing the treatment,  Leaving the hospital sooner than the proper time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F11.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of opioids,withdrawal state</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code></i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code></i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group, patients are given Clonidine 0.1 mg per oral q 12 hours, Benzodiazepine (Chlorodiazepoxide 10mg at 6 Am, 10 mg at 2 Pm and 20 mg at 10 Pm per oral), Indomethacin 100 mg if necessary, Omeprazole 1 mg per oral before eating breakfast, Ibuprofen 400 mg q 12 hours per oral, with Risperidone 1 mg daily, and with or without Gabapentin and if needed Serum and Vitamin C in a 10 day period of time</i_keyword>
      <i_keyword>Patients on Methadone Maintenance Therapy (MMT) for 45 days, are given Methadone 40 mg per oral in the first day and then this dose will be increased 5 mg daily for disappearing the withdrawal signs and symptoms at most until the 10th day and then this dose will gradually be reduced to zero until the end of the 45 day period, pain killer (NSAIDs (Indomethacin 100 mg if necessary) ) in the first ten days and also MOM syrup 10 cc q 8 hours per oral</i_keyword>
      <i_keyword>The patients in the third group, are given Methadone 10 mg in the first day, 5 mg in the second and third day and nothing in the forth and fifth day, and also Maintenance serum of ⅓⅔ 2 Lit daily IV if necessary,Clonidine 0.1 mg per oral q 12 hours, Chlorodiazepoxide 10mg at 6 Am, 10 mg at 2 Pm and 20 mg at 10 Pm per oral, Indomethacin 100 mg if necessary, Omeprazole 1 mg per oral before eating breakfast, Ibuprofen 400 mg q 12 hours per oral, with Risperidone 1 mg daily</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Less opioid withdrawal signs and symptoms. Timepoint: Daily. Method of measurement: The Pattern of Opioid Withdrawal Signs and Symptoms using Fultz chart.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-01-19</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ghoreishi Building, Daneshgah Street, Mashhad, IRAN Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
