<?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>IRCT201702131457N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-14</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of haloperidol on symptom of  opium withdrawal.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of efficacy and safety of Haloperidol on symptoms of acute opioids withdrawal</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/730</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Opium use disorder.</hc_freetext>
      <i_freetext>Intervention 1: patients receiving 15 mg or less than 15 mg of methadone, 5 mg haloperidol will be administered each day; patients receiving 15 to 30 mg of methadone, haloperidol will be administered 10 mg daily; patients receiving 30 to 45 mg of methadone, will be administered 15 mg haloperidol daily; and patients receiving more than 45 mg methadone, will be administered 20 mg haloperidol daily. Haloperidol will be continued for one week after discontinuation of methadone and thereafter it will be reduced half a 5 mg tablet daily until discontinued. Intervention 2: patients receiving 15 mg or less than 15 mg of methadone, 5 mg placebo will be administered each day; patients receiving 15 to 30 mg of methadone, placebo will be administered 10 mg daily; patients receiving 30 to 45 mg of methadone, will be administered 15 mg placebo daily; and patients receiving more than 45 mg methadone, will be administered 20 mg placebo daily. Placebo will be continued for one week after discontinuation of methadone and thereafter it will be reduced half a 5 mg tablet daily until discontinued.</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 Mehran Zarghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NeKa Road Sari, Zare Hospital</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815466848</zip>
        <telephone>+98 11 3328 5109</telephone>
        <email>mehran.zarghami@gmail.com; mzarghami@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mehran Zarghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neka Road Sari,Zare Hospital</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815466848</zip>
        <telephone>+98 11 3328 5109</telephone>
        <email>mehran.zarghami@gmail.com; mzarghami@mazums.ac.ir</email>
        <affiliation>Mazandaran 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:A  reliable history of opioids consumptions until the onset of the study; DSM-5 criteria for opioid use disorder; Positive urine rapid test of opioids&#13;
Exclusion criteria:Enzyme inducers medication usage or other medical treatments;History of Sensitivity to haloperidol; Poly substance use (Cannabinoids  ,Alcohol , barbiturates , benzodiazepines, analgesics) and use of antidepressants , other antipsychotics ,  beta blockers , alpha 2 agonists, inhibitors of CYP 3A4 , and CYP2D6 in the last month before study (except nicotine); Major depressive disorder, Bipolar mood disorder, severe anxiety disorders and Psychosis; Severe medical illnesses such as epilepsy, hepatitis, tuberculosis, AIDS, liver dysfunction, renal dysfunction; Pregnancy and Lactation; Electroconvulsive therapy in the  last 6 months; Suicidal ideation or suicidal attempt at the beginning of the study or within the last 6 months; Mental retardation; Neurological disorder such as dementia, uncontrolled epilepsy and history of head trauma ; Past history of neuroleptic malignant syndrome.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F11.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioral disorders due to use of opioids_dependence syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>patients receiving 15 mg or less than 15 mg of methadone, 5 mg haloperidol will be administered each day; patients receiving 15 to 30 mg of methadone, haloperidol will be administered 10 mg daily; patients receiving 30 to 45 mg of methadone, will be administered 15 mg haloperidol daily; and patients receiving more than 45 mg methadone, will be administered 20 mg haloperidol daily. Haloperidol will be continued for one week after discontinuation of methadone and thereafter it will be reduced half a 5 mg tablet daily until discontinued.</i_keyword>
      <i_keyword>patients receiving 15 mg or less than 15 mg of methadone, 5 mg placebo will be administered each day; patients receiving 15 to 30 mg of methadone, placebo will be administered 10 mg daily; patients receiving 30 to 45 mg of methadone, will be administered 15 mg placebo daily; and patients receiving more than 45 mg methadone, will be administered 20 mg placebo daily. Placebo will be continued for one week after discontinuation of methadone and thereafter it will be reduced half a 5 mg tablet daily until discontinued</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acute opioid withdrawal symptoms. Timepoint: every other day. Method of measurement: Objective opioid withdrawal scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Extrapyramidal symptoms, serum prolactin level. Timepoint: Extrapyramidal symptoms will be assessed by everyday clinical assessment, prolactine; and serum prolactin level, before &amp; after the end of the study. Method of measurement: History &amp; Physical Exam &amp; labratory test.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-01</approval_date>
        <contact_name>Mazandaran University of Medical Sciences &amp; Health Services</contact_name>
        <contact_address>NO.2 Building Mazandaran of Medical Sciences,Moallem Square Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
