<?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>IRCT20240723062524N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Psychological Treatment  in adults with cannabis use disorder</public_title>
      <acronym>CUD</acronym>
      <scientific_title>The Effectiveness of Matrix Treatment on Craving and Psychological Capital in  cannabis users</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78135</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed with a simple method and random numbers generated by computer software (Stat Trek software), which chooses the random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Cannabis Use Disorder (CUD). Condition 2: Cannabis Withdrawal Disorder (CWD).</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group consists of mild cannabis users who receive matrix intervention in 8 to 12 sessions based on family counseling, cognitive-behavioral therapy (CBT), motivational enhancement therapy (MET), and contingency management (CM) individually and with their families in two sessions per week. Intervention 2: The second intervention group includes moderate and severe cannabis users who receive matrix intervention in 12 to 16 sessions based on individual and weekly cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET). Intervention 3: The control group is non-intervention.</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:
The main variables and demographic data, including age, gender, marital status, and education

When:
One year following the publication of the results

To whom:
It will only be available to researchers in academic and scientific institutions.

Conditions:
To train and treat substance use and cannabis disorders

Where to obtain:
Correspondence with the west Tehran branch of Islamic Azad University, Tehran, Iran info@wtiau.ac.ir

How to obtain:
Correspondence with the Faculty of Medicine Sciences at the west Tehran branch of Islamic Azad University, Tehran, Iran info@wtiau.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Mollazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini Blvd, Department of Psychology, Ashtian Branch of Islamic Azad University, Ashtiyan, Markazi Province, Iran</address>
        <city>Ashtian</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3961813347</zip>
        <telephone>+98 86 3722 2500</telephone>
        <email>alimollazade@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Mollazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini Blvd, Department of Psychology, Ashtian Branch of Islamic Azad University, Ashtian, Iran.</address>
        <city>Ashtian</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3961813347</zip>
        <telephone>+98 86 3722 2500</telephone>
        <email>alimollazade@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>According to the fifth edition of the Diagnostic and Statistical Mental Health Analysis, Text Revision Criteria (DSM-5-TR), participants must have at least twelve months of experience with marijuana use.
They must also avoid stimulant drugs other than cigarettes and marijuana.
The participants must be between 18 and 50 years of age and have signed an ethical form indicating their consent.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants who require more advanced care than what an outpatient group can provide, such as those experiencing active mania or psychosis.
Any psychiatric or physical condition may find it challenging to communicate effectively.
The participant is concurrently receiving another medical or psychological intervention that is based on cognitive behavior therapy.
Participants who are unavailable during study sessions and have missed more than four sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F12.1</hc_code>
      <hc_code>F12.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cannabis abuse</hc_keyword>
      <hc_keyword>Cannabis dependence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group consists of mild cannabis users who receive matrix intervention in 8 to 12 sessions based on family counseling, cognitive-behavioral therapy (CBT), motivational enhancement therapy (MET), and contingency management (CM) individually and with their families in two sessions per week.</i_keyword>
      <i_keyword>The second intervention group includes moderate and severe cannabis users who receive matrix intervention in 12 to 16 sessions based on individual and weekly cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET).</i_keyword>
      <i_keyword>The control group is non-intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marijuana Craving Score. Timepoint: Before and after the intervention. Method of measurement: Marijuana Craving Questionnaire (MCQ).</prim_outcome>
      <prim_outcome>Diagnosis of cannabis use and severity. Timepoint: At the onset of both the study and the intervention. Method of measurement: The Structured Clinical Interview for Clinical Trials version (SCID-5-CT).</prim_outcome>
      <prim_outcome>Psychological Capital Score. Timepoint: Before and after the intervention. Method of measurement: Psychological Capital Questionnaire (PCQ).</prim_outcome>
      <prim_outcome>Diagnosis of cannabis use and severity. Timepoint: At the onset of the study and one month after the completion of the intervention,. Method of measurement: The Cannabis Use Disorders Identification Test (CUDIT-R-Pr) has been revised in Persian.</prim_outcome>
      <prim_outcome>Negative urine test for cannabis. Timepoint: Before intervention and 3, 6, 9, 12 and 16 weeks after intervention. Method of measurement: Cannabis urine test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient Health Score. Timepoint: Before and after the intervention. Method of measurement: Patient Health Questionnaire (PHQ-9).</sec_outcome>
      <sec_outcome>General Anxiety Disorder Score. Timepoint: Before and after the intervention. Method of measurement: General Anxiety Disorder Questionnaire (GAD-7).</sec_outcome>
      <sec_outcome>The Marijuana Withdrawal Checklist to assess the incidence and severity of perceived withdrawal symptoms. Timepoint: Before and after the intervention. Method of measurement: The Marijuana Withdrawal Checklist (MWC).</sec_outcome>
      <sec_outcome>Self-Efficacy Score to abstinence from marijuana. Timepoint: Before and after the intervention. Method of measurement: The Self-Efficacy Questionnaire (SEQ) for abstinence from marijuana.</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>West Tehran Branch of Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-27</approval_date>
        <contact_name>Islamic Azad University- Najafabad branch</contact_name>
        <contact_address>University Sq., Najafabad, Isfahan, Iran Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
