<?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>IRCT20170108031818N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-20</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive hypnotherapy in preventing the relapse of opium use in men treated with methadone</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of cognitive hypnotherapy (COGNITIVE HYPNOTHERAPY) in preventing the relapse of opium use in men treated with methadone compared to the control group in the addiction treatment center.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69818</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples are placed in one of the treatment groups including only methadone treatment or in the treatment group with methadone and cognitive hypnotherapy as a simple randomization and by lottery.</study_design>
      <phase>2</phase>
      <hc_freetext>Men treated with methadone.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the cognitive hypnotherapy intervention group, including 8 sessions of 60 minutes (the number of people in each session is maximum 8 people), it will be held once a week by a psychiatric specialist, and relaxation will be conducted by a psychiatric assistant. Cognitive hypnotherapy will consist of 8 sessions of 60 minutes that will be held once a week.In the first session, along with getting to know the patient and the current life situation of the patient and his family, as well as explaining the hypnosis treatment program and examining the patients' views on hypnosis, the progressive muscle relaxation method will be taught to the patients. At the end of the session, they are asked to do this exercise for 20 minutes every day until the next week, when it is time for the second session.In the second session, the patient will be explained about the unconscious and the effect of insinuations on it, hypnotherapy, insinuations related to relaxation and reducing mental pressure, and teaching exercises will be done.The purpose of the third session is to increase self-confidence and calmness in the patient. They will be familiar with the reminders of drug addiction such as time, place, friends, music, etc.The fourth session: While deepening the trance, they will learn about the harms of drug use and its negative effects.5th and 6th session: While taking the patients to the deepest depth of trance, insinuations of aversion to substances will be done.Seventh session: In deep ecstasy, the positive effects of staying in the desert, such as taking care of personal and family matters, deepening family relationships, work progress and prevention of damages, increasing self-confidence and morale of oneself and family members, educational progress of children, etc. will be suggested.The eighth session: The exercises that are done in the previous sessions will be reviewed and conditional suggestions will be made to make it easier to induce trance in the patient at home, and the patient will be told about self-hypnosis to eliminate the problems that arise as a result. Quitting occurs for him to use (such as insomnia, restlessness, pain, depression and temptation).The follow-up of patients after the completion of cognitive hypnotherapy sessions will be 3 months later and 6 months later. In this way, during a phone call with the participants, they are requested to come for a morphine urine test. The positive result indicates the existence of drug use during the last three days and is considered as a relapse of drug abuse. Intervention 2: Control group: Methadone only.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is "There is no further information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Zaman Kamkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Shast kola St.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>455435552</zip>
        <telephone>0173215846</telephone>
        <email>kamkar۷۲@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Zaman Kamkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Shast kola St.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4652865253</zip>
        <telephone>+98 17 3566 5254</telephone>
        <email>kamkar۷۲@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All opium consuming men who have completed a one-month detoxification course and are undergoing maintenance treatment with methadone and have a file in the addiction treatment center affiliated to 5 Azar Hospital in Gorgan.
Age 18–55 years
Not using other drugs and narcotic drugs for a month before
At least elementary education
No history of stimulant drug use</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Absence of more than 2 sessions of cognitive hypnotherapy
Non-cooperation of the patient to monitor the urine test before intervention, after cognitive hypnotherapy and 3 months and 6 months after treatment sessions.
Serious medical illness or major psychiatric disorder (depression, psychosis, etc.) based on a clinical interview by a psychiatric assistant</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the cognitive hypnotherapy intervention group, including 8 sessions of 60 minutes (the number of people in each session is maximum 8 people), it will be held once a week by a psychiatric specialist, and relaxation will be conducted by a psychiatric assistant. Cognitive hypnotherapy will consist of 8 sessions of 60 minutes that will be held once a week.In the first session, along with getting to know the patient and the current life situation of the patient and his family, as well as explaining the hypnosis treatment program and examining the patients' views on hypnosis, the progressive muscle relaxation method will be taught to the patients. At the end of the session, they are asked to do this exercise for 20 minutes every day until the next week, when it is time for the second session.In the second session, the patient will be explained about the unconscious and the effect of insinuations on it, hypnotherapy, insinuations related to relaxation and reducing mental pressure, and teaching exercises will be done.The purpose of the third session is to increase self-confidence and calmness in the patient. They will be familiar with the reminders of drug addiction such as time, place, friends, music, etc.The fourth session: While deepening the trance, they will learn about the harms of drug use and its negative effects.5th and 6th session: While taking the patients to the deepest depth of trance, insinuations of aversion to substances will be done.Seventh session: In deep ecstasy, the positive effects of staying in the desert, such as taking care of personal and family matters, deepening family relationships, work progress and prevention of damages, increasing self-confidence and morale of oneself and family members, educational progress of children, etc. will be suggested.The eighth session: The exercises that are done in the previous sessions will be reviewed and conditional suggestions will be made to make it easier to induce trance in the patient at home, and the patient will be told about self-hypnosis to eliminate the problems that arise as a result. Quitting occurs for him to use (such as insomnia, restlessness, pain, depression and temptation).The follow-up of patients after the completion of cognitive hypnotherapy sessions will be 3 months later and 6 months later. In this way, during a phone call with the participants, they are requested to come for a morphine urine test. The positive result indicates the existence of drug use during the last three days and is considered as a relapse of drug abuse.</i_keyword>
      <i_keyword>Control group: Methadone only</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Opium relapse. Timepoint: 3 months later and 6 months later. Method of measurement: The morphine urine test is a multi-drug test, and if morphine is positive in this test, it is considered as a relapse of drug abuse.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Impulsiveness. Timepoint: 3 months later and 6 months later. Method of measurement: Ernst Barratt Impulsivity Questionnaire.</sec_outcome>
      <sec_outcome>Reduced drug cravings. Timepoint: 3 months later and 6 months later. Method of measurement: with the Abbreviated Substance Craving Scale.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-05</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>Golestan University of Medical Sciences, shast kola St., Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
