<?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>IRCT20221214056816N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-12</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness of transcranial direct current stimulation and varenicline on, excutive function, cravings and,depression, anxiety and stress in smokers with major depressive disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison and Combination the effectiveness of transcranial direct current stimulation and varenicline on excutive function, cravings, depression, anxiety and stress in smokers with major depressive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67421</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done through simple random method using coin toss. In this way, subjects are randomly assigned to treatment and control groups, Blinding description: Blinding will be done in such a way that the subjects and the therapist are not aware of the assignment to the groups and the statistical analyst will also be blind to the therapist and the subjects.</study_design>
      <phase>2</phase>
      <hc_freetext>People with smoking.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: common protocol to reduce cravings in smokers through extracranial stimulation device (tDCS), placing the stimulating electrode (anode) on the right dorsolateral prefrontal cortex (DLPFC) and the inhibitory electrode (cathode), prefrontal cortex The dorsal side is left. Intervention 2: Intervention group: The use of varenicline is usually started as follows: the first three days, one tablet of 500 micrograms daily, days 4 to 7 one tablet (500 micrograms), from the 8th day onwards, one tablet of 1 mg twice a day. The complete period of taking varenicline is 12 weeks. It is possible that according to the doctor's opinion, in case of success in quitting smoking, it may continue for more than 12 weeks. Intervention 3: Intervention group: The protocol for the sham group is through the extracranial stimulation device (tDCS), placing the stimulating electrode (anode) on the right dorsolateral prefrontal cortex (DLPFC) and the inhibitory electrode (cathode) on the left dorsolateral prefrontal cortex. It runs for 40 seconds.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the confidentiality of each person's private data, the data is shared in the form of an article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Eskandari Zakaria</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital Zanjan University of Medical Sciences,</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513615788</zip>
        <telephone>+98 24 3354 4001</telephone>
        <email>eskandari.psychology@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zakaria Eskandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital Zanjan University of Medical Sciences,</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513615788</zip>
        <telephone>0098 33544001</telephone>
        <email>Eskandari.Psychology@Gmail.Com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the ability to give informed consent to participate in research
Being at least 18 and at most 65 years old
Daily consumption of more than ten cigarettes for at least two years(14)
Non-use of other substances such as: methamphetamine, opioid and benzodiazepine (specified through clinical interview by Ballinger)
Having a diagnosis of major depression
Failure to consider other severe psychiatric disorders that will be screened through the structured interview of SKID</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Consuming more than one marijuana cigarette per week
Having a history of neurological diseases such as Parkinson's, epilepsy, convulsions, strokes and cardiovascular problems
Having diseases related to the scalp
Having a history of head trauma
Presence of a device or tool in the head
Exiting from the research after absence In two continuous sessions of treatment
Pregnancy or breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tobacco use</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: common protocol to reduce cravings in smokers through extracranial stimulation device (tDCS), placing the stimulating electrode (anode) on the right dorsolateral prefrontal cortex (DLPFC) and the inhibitory electrode (cathode), prefrontal cortex The dorsal side is left.</i_keyword>
      <i_keyword>Intervention group: The use of varenicline is usually started as follows: the first three days, one tablet of 500 micrograms daily, days 4 to 7 one tablet (500 micrograms), from the 8th day onwards, one tablet of 1 mg twice a day. The complete period of taking varenicline is 12 weeks. It is possible that according to the doctor's opinion, in case of success in quitting smoking, it may continue for more than 12 weeks.</i_keyword>
      <i_keyword>Intervention group: The protocol for the sham group is through the extracranial stimulation device (tDCS), placing the stimulating electrode (anode) on the right dorsolateral prefrontal cortex (DLPFC) and the inhibitory electrode (cathode) on the left dorsolateral prefrontal cortex. It runs for 40 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decreasing score in depression, anxiety, stress Scale(DASS). Timepoint: 3 Month. Method of measurement: Dass questionnaire.</prim_outcome>
      <prim_outcome>Decreasing score in mood profile. Timepoint: 3 Month. Method of measurement: mood profile questionnaire.</prim_outcome>
      <prim_outcome>Decreasing score in craving questionnaire. Timepoint: 3 Month. Method of measurement: craving questionnaire.</prim_outcome>
      <prim_outcome>Improving inhibition in Stroop test. Timepoint: 3 Month. Method of measurement: Stroop software.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-13</approval_date>
        <contact_name>Zanjan University of Medical Sciences Research Ethics Committee</contact_name>
        <contact_address>Zanjan University of Medical Sciences-Shahid Beheshti Hospital, Department of Addiction Studies Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
