<?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>IRCT2014031611234N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-27</date_registration>
      <primary_sponsor>Cognitive Sciences and Technology Council</primary_sponsor>
      <public_title>Cumulative effects of transcranial direct current stimulation on meth craving</public_title>
      <acronym>tDCS</acronym>
      <scientific_title>Evaluating long-term therapeutic effects of transcranial direct current stimulation &#13;
with most efficient montage over the dorsolateral prefrontal cortex targeting &#13;
craving in methamphetamine abusers; Two Consecutive Randomized Clinical Trials</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11532</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Methamphetamine dependency.</hc_freetext>
      <i_freetext>Intervention 1: Direct current is delivered from a battery-driven, constant current stimulator (ActivaDoseII. Iontophoresis Delivery Unit, P/N00148-Rev A, ActivaTek, Inc. Salt Lake City UT 84119 USA) and transferred by a pair of 5×7 (35cm2) electrodes. In the first phase, 120 participants will be randomly assigned to a control group (n = 20) or a 5-intervention groups (n = 20 per group).Each of the intervention groups will receive one specific montages of real stimulation (1. Right anode, cathode extra-cephalic 2. Left anode, cathode extra-cephalic 3. Right anode, Left cathode 4 left anode, right cathode; 5. Left and right anode, cathode extra-cephalic), and the control group will receive sham stimulation. The tDCS Protocol for all groups will be 2mA during 20 minutes. The Immediate and cue induced craving will be assessed before and after stimulation by VAS, DDQ and CCICT, respectively. Intervention 2: In this study, control group will receive sham transcranial direct current stimulation (tDCS). For sham stimulation, the anode and cathode electrodes will have same position with the one of the intervention groups’ montages. However, the stimulator is ramped-up to 2 mA in 30s, then gradually ramped-down to 0 mA over the period of 1 minute, and then turned off but the electrodes will be on the scalp for 20 minutes and subjects will not be informed that the device is turned off.</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>Alireza Shahbabaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Center for Molecular and Cellular Imaging - Imam Khomini Hospital Complex - Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14185-171</zip>
        <telephone>+98 21 6658 1505</telephone>
        <email>Shahbabaie.ar@gmail.com</email>
        <affiliation>Institute for Cognitive Sciences Studies (ICSS)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Shahbabaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Center for Molecular and Cellular Imaging - Imam Khomini Hospital Complex - Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14185-171</zip>
        <telephone>+98 21 6658 1505</telephone>
        <email>Shahbabaie.ar@gmail.com</email>
        <affiliation>Institute for Cognitive Sciences Studies (ICSS)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria are: (1) the methamphetamine dependents being referred for treatment to Vardij Therapeutic Community Residential Center which is a specialized center for stimulants; (2) a history of at least 12 months of meth dependence (moderate or severe) based on DSM-V criteria before receiving treatment; (3) Being in the age range of 18-50; (4) being abstinence from any drugs except cigarettes, for at least a week prior to the experiment, confirmed by urine analysis inside the residential centre; (5) A history of meth using at least 6 days a week in the month before entering the treatment. (6) Being able to provide informed, written consent. Exclusion criteria include: (1) any current major psychiatric disorders (2) Moderate to severe traumatic brain injury with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study; (3) having intracranial metal implantation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F15.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence syndrom, Mental and behavioural disorders due to use of other stimulants, including methamphethamine</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Direct current is delivered from a battery-driven, constant current stimulator (ActivaDoseII. Iontophoresis Delivery Unit, P/N00148-Rev A, ActivaTek, Inc. Salt Lake City UT 84119 USA) and transferred by a pair of 5×7 (35cm2) electrodes. In the first phase, 120 participants will be randomly assigned to a control group (n = 20) or a 5-intervention groups (n = 20 per group).Each of the intervention groups will receive one specific montages of real stimulation (1. Right anode, cathode extra-cephalic 2. Left anode, cathode extra-cephalic 3. Right anode, Left cathode 4 left anode, right cathode; 5. Left and right anode, cathode extra-cephalic), and the control group will receive sham stimulation. The tDCS Protocol for all groups will be 2mA during 20 minutes. The Immediate and cue induced craving will be assessed before and after stimulation by VAS, DDQ and CCICT, respectively.</i_keyword>
      <i_keyword>In this study, control group will receive sham transcranial direct current stimulation (tDCS). For sham stimulation, the anode and cathode electrodes will have same position with the one of the intervention groups’ montages. However, the stimulator is ramped-up to 2 mA in 30s, then gradually ramped-down to 0 mA over the period of 1 minute, and then turned off but the electrodes will be on the scalp for 20 minutes and subjects will not be informed that the device is turned off.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Immediate meth craving. Timepoint: Pre &amp; Post brain stimulation. Method of measurement: visual-analogue scale(VAS).</prim_outcome>
      <prim_outcome>Basic meth craving. Timepoint: Pre &amp; Post brain stimulation. Method of measurement: Desires for Drug Questionnaire Adapted for Meth (DDQ).</prim_outcome>
      <prim_outcome>Cue-induced craving. Timepoint: Pre &amp; Post brain stimulation. Method of measurement: Computerized cue-induced craving assessment task (CICT).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mood state. Timepoint: Pre and Post brain stimulation. Method of measurement: Positive and Negative Affect (PANAS) questionnaire.</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>Cognitive Sciences and Technology Council</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-16</approval_date>
        <contact_name>university of social welfare and rehabilitation sciences</contact_name>
        <contact_address>kodakyar Ave., daneshjo Blvd.,Evin,Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
