<?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>IRCT2012102311234N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-11-28</date_registration>
      <primary_sponsor>Vice Chancellor for Research,Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Transcranial Direct Current Stimulation (tDCS) over Craving in abstinence methamphetamine user</public_title>
      <acronym></acronym>
      <scientific_title>Online Transcranial DC Stimulation (tDCS) over the Dorsolateral Prefrontal Cortex and Cue Induced Craving in Methamphetamine Dependents: A double-blind, sham-controlled study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11531</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Methamphetamine dependency.</hc_freetext>
      <i_freetext>Intervention 1: Direct current was 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. Electrodes were standard carbonic, covered with a normal saline socked sponge cases. Subjects were randomized to receive sham or anodal tDCS. In this study, intervention group received real tDCS. In this case, the anode electrode was placed on right Dorsolateral prefrontal cortex (rDLPFC) and cathode electrode was placed on the forehead above the left eye (Supraorbital). 2 mA current for 20 minimums was passed from patient's brain. In&#13;
our study, washout period between 2 session interventions was at least 72-h, to avoid the potential of any&#13;
carry-over effects due to previous stimulation. Intervention 2: In this study, control group received sham transcranial direct current stimulation(tDCS).  For sham stimulation, the same methods of placing anode and cathode were used, however, the stimulator was 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 were on the scalp for 20 minutes and subjects were not 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>18 Pezeshkpour Alley, Vali-e-asr Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1594834111</zip>
        <telephone>+98 21 8880 2063</telephone>
        <email>shahbabai.a@iricss.org</email>
        <affiliation>Iranian institute for Cognitive Science Studies</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Ekhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Keshavarz Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5542 1177</telephone>
        <email>h_ekhtiari@razi.tums.ac.ir</email>
        <affiliation>Research Center for Molecular and Cellular Imaging (RCMCI)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria;&#13;
 Having a history of at least 12 months methamphetamine dependence, based on DSM-IV-TR criteria; before entering the treatment program and also being abstinence from any drugs except cigarettes, at least for the last week; We tested subjects’ cue-reactivity in the recruitment process based on their subjective reports of craving feeling after exposure to 2 drug-related cues, which were not included in the main craving task; Subjects were excluded if at least their mean craving self-report was below 20 out of 100.&#13;
&#13;
Exclusion Criteria:&#13;
Individuals with any current or past clinical significant neurologic disorder; usage of central nervous system-effective medication; history of epilepsy; brain surgery;tumor; intracranial metal implantation; clinically significant head trauma; or any clinical significant psychiatric disorder (in axis I, except substance-related disorders).</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Direct current was 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. Electrodes were standard carbonic, covered with a normal saline socked sponge cases. Subjects were randomized to receive sham or anodal tDCS. In this study, intervention group received real tDCS. In this case, the anode electrode was placed on right Dorsolateral prefrontal cortex (rDLPFC) and cathode electrode was placed on the forehead above the left eye (Supraorbital). 2 mA current for 20 minimums was passed from patient's brain. In&#13;
our study, washout period between 2 session interventions was at least 72-h, to avoid the potential of any&#13;
carry-over effects due to previous stimulation.</i_keyword>
      <i_keyword>In this study, control group received sham transcranial direct current stimulation(tDCS).  For sham stimulation, the same methods of placing anode and cathode were used, however, the stimulator was 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 were on the scalp for 20 minutes and subjects were not informed that the device is turned off.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Methamphetamine Craving. Timepoint: before intervention, online with intervention and After intervention. Method of measurement: Computerized Cue-induced  Craving Assessment Task(CCIC), Desires for Drug Questionnaire (DDQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mood Status. Timepoint: It is assessed before and after brain stimulation and induced craving, in both sessions. Method of measurement: Positive and Negative Affect Scale(PANAS).</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>Vice Chancellor for Research,Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-28</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor, Central Organization of Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd Iran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
