<?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>IRCT20180218038782N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-09</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of cue exposure therapy on treatment outcome of stimulant use disorder</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of cue exposure therapy on treatment outcome of stimulant use disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29702</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: simple randomization by app or websites, Blinding description: patients will not get any informations about assignment process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stimulant use disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: cue exposure treatment. Intervention 2: Control group: treatment as usual (TAU).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all of data will be available with regard to confidentiality principle

When:
starting 6 months after publication

To whom:
only for researchers

Conditions:
those researchers interested to re analysis or doing meta analysis can request for receiving data

Where to obtain:
to get data they should send a request to  email address of Talebizadeh:
talebizadeh.m86@gmail.com

How to obtain:
researchers should note why they need data files and how they are going to use them.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Meghdad Talebizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1. Tehran Psychiatric Institute, School of Behavioral Sciences and Mental Health, mansouri ave, Niayesh st. satarkhan st. tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>talebizadeh.m86@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Meghdad Talebizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1. Tehran Psychiatric Institute, School of Behavioral Sciences and Mental Health, mansouri ave, Niayesh st. satarkhan st. tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>talebizadeh.m86@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>stimulant use disorder diagnosis
not using any kind of drug except of nicotine within two weeks before  program starting
Ability of reading and writing persian language
Completion of informed consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>64 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>having sever suicidal ideation
having psychotic symptoms
having acute physical problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F15.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other stimulant dependence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: cue exposure treatment</i_keyword>
      <i_keyword>Control group: treatment as usual (TAU)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Treatment outcome includes: addiction severity, craving, relapse rate, quality of life and severity of depression, anxiety and stress that will be measured by addiction severity index (ASI), Desires for Drug Questionnaire (DDQ), Obsessive Compulsive Drug Use Scale (OCDUS), urine test, World Health Organization Quality of Life-Brief (WHOQOL-BREF) and Depression Anxiety Stress Scales (DASS-21). Timepoint: assessment will complete at pre-test, post-test and follow up (3 months after treatment completion). Method of measurement: addiction severity index (ASI), Desires for Drug Questionnaire (DDQ), Obsessive Compulsive Drug Use Scale (OCDUS), urine test, World Health Organization Quality of Life-Brief (WHOQOL-BREF) and Depression Anxiety Stress Scales (DASS-21).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Addiction severity. Timepoint: pretest, post test, 3 months follow up. Method of measurement: addiction severity index (ASI).</sec_outcome>
      <sec_outcome>Craving. Timepoint: pretest, post test, 3 months follow up. Method of measurement: Desires for Drug Questionnaire (DDQ) and Obsessive Compulsive Drug Use Scale (OCDUS).</sec_outcome>
      <sec_outcome>Relapse rate. Timepoint: pretest, post test, 3 months follow up. Method of measurement: urine test.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: pretest, post test, 3 months follow up. Method of measurement: World Health Organization Quality of Life-Brief (WHOQOL-BREF).</sec_outcome>
      <sec_outcome>Severity of depression, anxiety and stress. Timepoint: pretest, post test, 3 months follow up. Method of measurement: Depression Anxiety Stress Scales (DASS-21).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-18</approval_date>
        <contact_name>Ethics commitee of Iran univeristy of medical siences</contact_name>
        <contact_address>Deputy of research and technology, Iran University of Medical Sciences,  Shahid Hemmat Highway,  Tehran,IRAN. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
