<?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>IRCT2015120625384N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-24</date_registration>
      <primary_sponsor>Behjoo Brain Center</primary_sponsor>
      <public_title>Efficacy of transcranial direct current stimulation in reduction of anxiety and crystalline heroin  craving.</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of transcranial direct current stimulation of dorsolateral prefrontal cortex on modulation of anxiety and craving in crystalline heroin dependents in MMT program.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21250</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Crystalline Heroin Dependence.</hc_freetext>
      <i_freetext>Intervention 1: Direct current will be delivered from a constant current stimulator (ActivaDose), and will be  transferred by a pair of (35 cm2) electrodes with stimulation intensity of 2mA. Electrodes are standard carbonic, covered with a normal saline soaked sponge cases. In current stimulations (right anodal/left cathodal), the anod electrod will be placed on the right DLPFC (F4), and the cathode electrod will be placed on the left DLPFC (F3). In current stimulations (right cathodal/left anodal), the cathod electrod will be placed on the right DLPFC (F4), and the anod electrod will be placed on the left DLPFC (F3). The stimulation will be performed randomly for subjects in the experimental group during 2 sessions.  Subjects in experimental groups will receive sham stimulation at first session. The only difference in this kind of stimulation is that the current will cut after 30s and primarily itching and sting will be felt by the subject. The Stimulation will be done for 20min. To omit the carry over effect of multiple stimulations, the experiments were performed at 72 hrs intervals. Intervention 2: Direct current will be delivered from a constant current stimulator (ActivaDose), and will be  transferred by a pair of (35 cm2) electrodes with stimulation intensity of 2mA. Electrodes are standard carbonic, covered with a normal saline soaked sponge cases. Subjects in control group will receive sham stimulation in 1 session. The only difference in this kind of stimulation is that the current will cut after 30s and primarily itching and sting will be felt by the subject. The Stimulation will be done for 20min.</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>Peyman Hassani Abharian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattarkhan Street, After Asadi</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4429 3384</telephone>
        <email>behjoobraincenter@gmail.com abharian1972@yahoo.com</email>
        <affiliation>Behjoo Brain Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Peyman Hassani Abharian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattarkhan Street, After Asadi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4429 3384</telephone>
        <email>behjoobraincenter@gmail.com abharian1972@yahoo.com</email>
        <affiliation>Behjoo Brain Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 25 to 50 year-old; right handed male; crystalline heroin smokers, with a history of at least 12 and at most 24 months of crystalline heroin dependence based on DSM-V criteria. Subjects at least have five years education, and are able to read, and understand the questions. Accept and sign the consent form. Exclusion criteria: any current or past major clinical neurologic disorders; central nervous system-effective medication intake; history of epilepsy; brain surgery; brain tumor; intracranial metal implantation; clinically significant head trauma, or any major clinical psychiatric disorders (in axis I, except substance-related disorders).</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Direct current will be delivered from a constant current stimulator (ActivaDose), and will be  transferred by a pair of (35 cm2) electrodes with stimulation intensity of 2mA. Electrodes are standard carbonic, covered with a normal saline soaked sponge cases. In current stimulations (right anodal/left cathodal), the anod electrod will be placed on the right DLPFC (F4), and the cathode electrod will be placed on the left DLPFC (F3). In current stimulations (right cathodal/left anodal), the cathod electrod will be placed on the right DLPFC (F4), and the anod electrod will be placed on the left DLPFC (F3). The stimulation will be performed randomly for subjects in the experimental group during 2 sessions.  Subjects in experimental groups will receive sham stimulation at first session. The only difference in this kind of stimulation is that the current will cut after 30s and primarily itching and sting will be felt by the subject. The Stimulation will be done for 20min. To omit the carry over effect of multiple stimulations, the experiments were performed at 72 hrs intervals.</i_keyword>
      <i_keyword>Direct current will be delivered from a constant current stimulator (ActivaDose), and will be  transferred by a pair of (35 cm2) electrodes with stimulation intensity of 2mA. Electrodes are standard carbonic, covered with a normal saline soaked sponge cases. Subjects in control group will receive sham stimulation in 1 session. The only difference in this kind of stimulation is that the current will cut after 30s and primarily itching and sting will be felt by the subject. The Stimulation will be done for 20min.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after stimulation. Method of measurement: Hamilton Anxiety Scale.</prim_outcome>
      <prim_outcome>Instant craving. Timepoint: Before and after stimulation. Method of measurement: Drug Desire Questionnair.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>TDCS side effects. Timepoint: After stimulation. Method of measurement: tDCS side effects check list.</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>Behjoo Brain Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-06</approval_date>
        <contact_name>Islamic Azad University Karaj Branch</contact_name>
        <contact_address>Shahid Moazen and Esteghlal Blvd. Rajaei Shahr, Karaj Rajaei Shahr  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
