<?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>IRCT20170702034844N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-16</date_registration>
      <primary_sponsor>Deputy for Research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Screening, Brief Intervention and Referral to Treatment (SBIRT) for Patients with Screen Positive for Alchohol and Drug Dependence</public_title>
      <acronym>ED-SBIRT</acronym>
      <scientific_title>Screening, Brief Intervention and Referral to Treatment (SBIRT) for Patients with Screen Positive for Alcohol and Drug Dependence among Referrals of Emergency Department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization: Using a random sequence generation, a quadrilateral block is used with a random number table.
Allocation: By a third-party supervisor who is a physician at the National Center for Addictive Studies, and coordinating the placement of each referral in each treatment group.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Alchohol  dependence. Condition 2: Opioids dependence. Condition 3: Stimulants (methamphetamine) dependence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group who screened positive for alcohol and drug dependence (opioids and methamphetamine) using AUDIT and ASSIST questionnaires and have a diagnosis of alcohol and drug dependence based on ICD-10, will receive treatment as usual and one 20-30 minutes brief motivational intervention by trained clinical psychologist aiming at referral to Psychiatric Clinic, Iranian National Center for Addiction Studies for further assessment and treatment. Participants will also receive one telephone follow-up within one week of discharge in order to remind them for referral. Intervention 2: Control group: Treatment as usual for medical and psychiatric stabilization in emergency department ward plus a brochure on importance and availability of alcohol and drug (opioids and methamphetamine) treatment in Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS).</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:
Participants data file: The participants data without identifying information will be available after completion of the study. Clinical study report: The clinical study report will be available after completion of the study.

When:
September 2019

To whom:
Researchers of psychiatric disorders clinical studies

Conditions:
Using study data for systematic reviews and meta-analysis studies ispermitted.

Where to obtain:
Dr. Alireza Noroozi Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS) Address: No 486, South Kargar St, Tehran, Iran Email: a_r_noroozi@yahoo.com

How to obtain:
The data request need to clearly define data needs. The study contact person will provide available data within 1 week after receiving the req

Comments:
None</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Alireza Noroozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1336616357</zip>
        <telephone>+98 21 5541 5225</telephone>
        <email>a_r_noroozi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Alireza Noroozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1336616357</zip>
        <telephone>+98 21 5541 5225</telephone>
        <email>a_r_noroozi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Admission to the Emergency Department of Poisoning Hospital
Detection of alcohol or drug intoxication (opioids, methamphetamine)
age 18-65
Stabilization from a medical point of view
Informed Consent to Enter Study
Literacy reading and writing
Positive screening for alcohol dependence using AUDIT, Drug dependence using ASSIST and diagnosis of alcohol and drug dependence based on ICD-10 criteria</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The risk of suicide, abuse or violence
Occurrence of psychosis
Failure to understand the study protocol and answer the questionnaires
Participation in another intervention research project</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F10.2</hc_code>
      <hc_code>F11.2</hc_code>
      <hc_code>F15.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of alcohol: dependence syndrome</hc_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of opioids: dependence syndrome</hc_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of stimulants: dependence syndrome</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: Participants in this group who screened positive for alcohol and drug dependence (opioids and methamphetamine) using AUDIT and ASSIST questionnaires and have a diagnosis of alcohol and drug dependence based on ICD-10, will receive treatment as usual and one 20-30 minutes brief motivational intervention by trained clinical psychologist aiming at referral to Psychiatric Clinic, Iranian National Center for Addiction Studies for further assessment and treatment. Participants will also receive one telephone follow-up within one week of discharge in order to remind them for referral.</i_keyword>
      <i_keyword>Control group: Treatment as usual for medical and psychiatric stabilization in emergency department ward plus a brochure on importance and availability of alcohol and drug (opioids and methamphetamine) treatment in Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percent of successful referral to specialized substance treatment center within 1 month of discharge. Timepoint: One week and 1 month after discharge. Method of measurement: Registration of clients referred to Psychiatric Clinic, Iranian National Center for Addiction Studies through this project.</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>Deputy for Research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-21</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences (TUMS), Vice-Chancellor for Research</contact_name>
        <contact_address>6th Floor, Central Building of Tehran University of Medical Sciences (TUMS), Ghods St., Keshavarz Blv. Tehran, Iran, Islamic Republic Of tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
