<?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>IRCT20161026030510N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-29</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of electrical extracranial stimulation of the brain (TDCS) combined with matrix psychotherapy in comparison with matrix psychotherapy alone in reducing cravings and improving cognitive functions in the methamphetamine withdrawal phase</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of electrical extracranial stimulation of the brain (TDCS) combined with matrix psychotherapy in comparison with matrix psychotherapy alone in reducing cravings and improving cognitive functions in the methamphetamine withdrawal phase</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48726</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization  performed with simple method and random numbers generated by computer software (Stat Trek) which choose the random numbers.Then, we consider the specific numbers for both groups for example:  the even numbers are for experimental group and odd numbers are for the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Methamphetamine abusers.</hc_freetext>
      <i_freetext>Intervention 1: Rreal tDCS: 11 patients in this group  received tDCS with craving therapy protocol during 15 sessions; they also received 24 sessions of psychological therapy based on the matrix protocol. Therapeutic protocol of intervention group (real TDCS) included 2MA current for 20 minutes in form of DC current. In this research, the direct electrical current was received from an electric current generator that works with batteries then transferred to a pair of electrodes 5×7 (35 cm2). Carbon electrodes were placed inside the sponge coating impregnated with serum.The matrix protocol includes: a variety of psychological therapies for patients. Intervention 2: Sham tDCS: 8 patients in group received 15 sessions tDCS with craving treatment protocol through shame method and without effectiveness (without informing the patient); they also received 24 sessions of psychological therapy based on the matrix protocol.  The matrix protocol includes: a variety of psychological therapies for patients. Intervention 3: Control group:  9 patients in group 3- as a control group- just received 24 sessions of psychological therapy based on the matrix protocol. The matrix protocol includes: a variety of psychological therapies for patients.</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:
Clinical and cognitive outcomes of patients after the intervention

When:
2020

To whom:
Researchers

Conditions:
Researchers from all scientific centers

Where to obtain:
Email

How to obtain:
Email - 3 Weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Reza Arezoomandan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansouri St, Faculty of Behavioral Sciences and Mental Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>Arezoomandan@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Reza Arezoomandan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansouri St., Faculty of Behavioral Sciences and Mental Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1555</telephone>
        <email>Arezoomandan@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who had referred to the common accommodation and outpatient treatment center in order to quite methamphetamine addiction
Having at least 12-month experience of methamphetamine addiction based on the DSM-5 criteria
Drug abuse in 6 days a week,
Avoiding any drug or stimulant abuse except for cigarette
Age: 18-50,
Consent signing of ethical form.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having any psychiatric disorder except for drug-related disorders,
Traumatic brain injuries (medium to severe) along with neurologic deficits or suffering from acute and unstable medical conditions that may put the patient at risk,
Having metal implants inside the skull, mental retardation, organic brain disorder, having serious suicidal thoughts,
Receiving another medical or psychological intervention at the same time.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Rreal tDCS: 11 patients in this group  received tDCS with craving therapy protocol during 15 sessions; they also received 24 sessions of psychological therapy based on the matrix protocol. Therapeutic protocol of intervention group (real TDCS) included 2MA current for 20 minutes in form of DC current. In this research, the direct electrical current was received from an electric current generator that works with batteries then transferred to a pair of electrodes 5×7 (35 cm2). Carbon electrodes were placed inside the sponge coating impregnated with serum.The matrix protocol includes: a variety of psychological therapies for patients</i_keyword>
      <i_keyword>Sham tDCS: 8 patients in group received 15 sessions tDCS with craving treatment protocol through shame method and without effectiveness (without informing the patient); they also received 24 sessions of psychological therapy based on the matrix protocol.  The matrix protocol includes: a variety of psychological therapies for patients</i_keyword>
      <i_keyword>Control group:  9 patients in group 3- as a control group- just received 24 sessions of psychological therapy based on the matrix protocol. The matrix protocol includes: a variety of psychological therapies for patients</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Craving Score in Craving questionnaire. Timepoint: Before and after the intervention. Method of measurement: Craving questionnaire or OCDUS - Obsessive Compulsive Drug Use Scale.</prim_outcome>
      <prim_outcome>Working memory score in Wechsler subscale. Timepoint: Before and after the intervention. Method of measurement: The digit span subscale of Wechsler Intelligence Scale.</prim_outcome>
      <prim_outcome>Cognitive function score in Wisconsin Scale. Timepoint: Before and after the intervention. Method of measurement: Wisconsin Test.</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>.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-11</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences,Shahid Hemmat Highway; Next to Milad Tower Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
