<?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>IRCT2016042816564N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-08</date_registration>
      <primary_sponsor>Urmia University of Medical Sciences, Vice Chancellor of Research</primary_sponsor>
      <public_title>The effectiveness of  applying continuous care model on lapse and craving of patients  that   treated are with methadone maintenance therapy</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of  applying continuous care model on lapse and craving of patients  that   are treated with methadone maintenance therapy  in  Razi Educational and Treatment Center  of  Urmia 2016</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>95</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15478</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Opioid Dependency. Condition 2: Cannabis drug dependence. Condition 3: Sedative or hypnotic drug dependence. Condition 4: Cocaine dependence. Condition 5: Hallucinogenic drug dependence.</hc_freetext>
      <i_freetext>Intervention 1: Continuous Care Model will be implemented on intervention group over a period of 3 months. This model consists of 4 stages which will be done individually. Orientation stage: This stage involves introduction, indicating obviously the objectives and expectations of nurse in the study, determining the expectations of patient, complete the consent, agreement and determining the appointment time and telephone meeting. This stage will be implemented for one session about 20 to 40 minutes. Sensitization stage: At this stage the aim is to involve the patient in the implementation of continuous care and understand the nature of addiction. And also, care consultation will be given about addiction features, substances  withdrawal and intoxication signs,  how to prevent them, tempting and risk factors and the need to avoid them, the need to continue the treatment and timely and regular visits to addiction treatment center,  the importance of physical activity and sport and distraction, healthy relationships and participate in social activities,  encourage to use the experiences of treated people, the necessity of leaving bad habits and the importance of continued  health behaviors. Counseling and continuous care lead to increase patients’ confidence. Control stage: In this stage, the goal is to change fundamentally and persistently the health behaviors in order to protect and promote leaving state. Then, we will continue to have face to face and telephone counseling and control care needs, the process of care, new problems, persistence of health behaviors, and adherence to treatment. Evaluation stage: That is the fourth and final step which will be considered in all stages. At this stage, care process, successes and failures and respective indices y filling out the questionnaires and recorded clinical findings will be evaluated. Intervention 2: Orientation stages will be implemented as well as for the control group but will differ in terms of time and expectations and future programs slightly. Because the purpose of the orientation stage to the control group is only encouraging the cooperation in implementing periodical controls to complete the intended data. This group will be controlled and treated with usual and ordinary care approaches that are available in the center.</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>Javad Namazpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.9- 11Alley- Azari Alley-Taavon 2 eve- Ahandost Blvd -Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715876663</zip>
        <telephone>+98 44 3346 4788</telephone>
        <email>razi_ psychitry@umsu.ac.ir</email>
        <affiliation>Urmia University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moloud Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 24- Fourth alley- 14 m third- rodaky Blvd- Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44327549614</telephone>
        <email>Radfar.m@umsu.ac.ir; mradfar1343@gmail.com</email>
        <affiliation>Faculty of Nursing &amp; Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Being between 18-48 years old, the diagnostic criteria for opioid dependence, according to psychiatrist, passing at least 3 months of being treated with methadone maintenance therapy and residence in the city of Urmia&#13;
Exclusion criteria: Psychological disorders that require hospitalization, use of antipsychotics and anticonvulsants at the time of entering the study and lack of willingness or ability to participate in the continuous care meetings</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>48 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ّF11</hc_code>
      <hc_code>F12</hc_code>
      <hc_code>F13</hc_code>
      <hc_code>F14</hc_code>
      <hc_code>ّّّF16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of opioids</hc_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of cannabinoids</hc_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of sedatives or hypnotics</hc_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of cocaine</hc_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of hallucinogens</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Continuous Care Model will be implemented on intervention group over a period of 3 months. This model consists of 4 stages which will be done individually. Orientation stage: This stage involves introduction, indicating obviously the objectives and expectations of nurse in the study, determining the expectations of patient, complete the consent, agreement and determining the appointment time and telephone meeting. This stage will be implemented for one session about 20 to 40 minutes. Sensitization stage: At this stage the aim is to involve the patient in the implementation of continuous care and understand the nature of addiction. And also, care consultation will be given about addiction features, substances  withdrawal and intoxication signs,  how to prevent them, tempting and risk factors and the need to avoid them, the need to continue the treatment and timely and regular visits to addiction treatment center,  the importance of physical activity and sport and distraction, healthy relationships and participate in social activities,  encourage to use the experiences of treated people, the necessity of leaving bad habits and the importance of continued  health behaviors. Counseling and continuous care lead to increase patients’ confidence. Control stage: In this stage, the goal is to change fundamentally and persistently the health behaviors in order to protect and promote leaving state. Then, we will continue to have face to face and telephone counseling and control care needs, the process of care, new problems, persistence of health behaviors, and adherence to treatment. Evaluation stage: That is the fourth and final step which will be considered in all stages. At this stage, care process, successes and failures and respective indices y filling out the questionnaires and recorded clinical findings will be evaluated.</i_keyword>
      <i_keyword>Orientation stages will be implemented as well as for the control group but will differ in terms of time and expectations and future programs slightly. Because the purpose of the orientation stage to the control group is only encouraging the cooperation in implementing periodical controls to complete the intended data. This group will be controlled and treated with usual and ordinary care approaches that are available in the center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lapse. Timepoint: During the 3 months and 3 months before the study intervention. Method of measurement: Nominal-Lapse and absence check list.</prim_outcome>
      <prim_outcome>Craving. Timepoint: before and during the 3 months of intervention. Method of measurement: Craving Questionnaire after leaving.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Urmia University of Medical Sciences, Vice Chancellor of Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-18</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences and Health Serviceو, Next Emergency Center, Resalat Blvd Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
