<?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>IRCT20220823055784N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-12</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Evaluation of the additive effect of transcranial direct current stimulation (tDCS)and Haboshefa in combination with conventional non-pharmacological therapies in reducing the temptation ,improvement of cognitive ability and stress in cannabis users.</public_title>
      <acronym>کانابیس</acronym>
      <scientific_title>Evaluation of the additive effect of transcranial direct current stimulation (tDCS)and Haboshefa in combination with conventional non-pharmacological therapies in reducing the temptation ,improvement of cognitive ability and stress in cannabis users.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65467</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: If the last number of national code (identity number) is odd ,The patient will be in the TDCS group; And if it is even the patient will be in habolshafa group, Blinding description: The drug packs are coded in two forms of real drug and placebo in the Shahed university, And the investigation team is not informed about the codes.
In the TDCS group the patients are coded in two groups and only the operator has the information about the codes.</study_design>
      <phase>2-3</phase>
      <hc_freetext>cannabis abuse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: TDCS procedure perform in 20 session with standard protocol of craving reduction in DLPFC .Half patient receive real TDCS and other half sham TDCS .In this method single canal stimulation which Anod placed  in F3 region and Cathod placed in F4 region is performed by previous studies .Duration of each session is 20 minutes and 2 MA stimulation will perform  if tolarated.2 outpatient session each week present beside of standard psychological thrapy.Urine test perform weekly for cannabis depend on it`s halflife. Intervention 2: Intervention group2 :Receive Habolshafa capsules weekly and consume 3 capsules per day each 8 hour .Drug packs contains 21 capsules each week .Real and placebo capsules coded in Shahed university without information to patient and research team .Duration of treatment is 12 week according to previous studies .Each week patients examined for drug adverse effect and urine cannabis test by the research team.</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:
data will be published after making undetectable

When:
from 1402

To whom:
research center of universities

Conditions:
data analysis allowed

Where to obtain:
dr_yasha_fayaz@yahoo.com
yasha fayaz faizy

How to obtain:
after submitting email , the answer posted after about 30 days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ِYasha fayaz faizy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.31 ,bakhshdari ave,karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۱۵۵۶۶۶۴۷۲</zip>
        <telephone>+98 26 3221 9703</telephone>
        <email>dr_yasha_fayaz@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasha fayaz faizy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.31 , bakhshdari ave,karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۱۵۵۶۶۶۴۷۳</zip>
        <telephone>+98 26 3221 9703</telephone>
        <email>dr_yasha_fayaz@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of cannabis abuse criteria at least for 6 months
Absence of any other obvious psychiatric disorder such as bipolar or etc.
Age between 20 and 40
Male gender</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Presence of underlying medical disease such as diabetes or malignancy or hypertension
Any other drug abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F12.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cannabis abuse</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: TDCS procedure perform in 20 session with standard protocol of craving reduction in DLPFC .Half patient receive real TDCS and other half sham TDCS .In this method single canal stimulation which Anod placed  in F3 region and Cathod placed in F4 region is performed by previous studies .Duration of each session is 20 minutes and 2 MA stimulation will perform  if tolarated.2 outpatient session each week present beside of standard psychological thrapy.Urine test perform weekly for cannabis depend on it`s halflife.</i_keyword>
      <i_keyword>Intervention group2 :Receive Habolshafa capsules weekly and consume 3 capsules per day each 8 hour .Drug packs contains 21 capsules each week .Real and placebo capsules coded in Shahed university without information to patient and research team .Duration of treatment is 12 week according to previous studies .Each week patients examined for drug adverse effect and urine cannabis test by the research team.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Craving. Timepoint: Start and end of study. Method of measurement: MCQ.</prim_outcome>
      <prim_outcome>Memory. Timepoint: Start and end of study. Method of measurement: Wechsler memory exam.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Start and end of study. Method of measurement: Hamilton depression exam.</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>Habolshafa capsules</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-04</approval_date>
        <contact_name>ّIran university medical ethic comitee</contact_name>
        <contact_address>No.31 bakhshdari ave.,thaleghani street ,karaj karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
