<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03748875</url>
  </required_header>
  <id_info>
    <org_study_id>JDu-006</org_study_id>
    <nct_id>NCT03748875</nct_id>
  </id_info>
  <brief_title>The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents</brief_title>
  <official_title>The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Mental Health Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Amphetamine-type stimulants (ATSs) have become the most important medical issue as well as&#xD;
      the social problem. Compared with traditional drugs, ATS are highly neurotoxin and can induce&#xD;
      cognitive deficit and psychotic symptoms. Due to lack of efficient medical treatment,&#xD;
      psychotherapy and behavioral interventions are the main treatment strategies so far.&#xD;
      Mindful-based relapse prevention (MBRP) which combined mindfulness with relapse prevention&#xD;
      skills, as a novel intervention, has been widely used in prevent craving and relapse among&#xD;
      addictions. While the current research of MBRP mechanism focus on emotion regulation circuit,&#xD;
      and there was no study to explore the impulsive circuit, which is the important factor that&#xD;
      induce the addiction and relapse. However, there was no report about the influence of MBRP on&#xD;
      Prefrontal-striatal circuits. Based on the previous results, the proposed study will focus on&#xD;
      evaluating the mechanism of MBRP on prefrontal-striatal circuits, neuropsychological tests&#xD;
      and functional MRI will be used to investigate the neurobiological mechanism of MBRP on&#xD;
      prefrontal-striatal circuits and related impulsive behaviors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>craving change</measure>
    <time_frame>change from baseline, 4，8，12，27and 52 weeks</time_frame>
    <description>craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving</description>
  </primary_outcome>
  <primary_outcome>
    <measure>impulsiveness change</measure>
    <time_frame>baseline，4，8，12，27and 52 weeks</time_frame>
    <description>impulsiveness will be measured by Barratt Impulsiveness Scale, the scale is a 30 item self-report measure, Rarely/Never = 1，Occasionally = 2，Often = 3，Almost Always/Always = 4. Assessment is indicated by the total score added together.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional connectivity change between prefrontal cortex and striatum</measure>
    <time_frame>baseline, 8 and 12weeks</time_frame>
    <description>functional connectivity between prefrontal cortex and striatum will be measured by fMRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cognitive function improvement</measure>
    <time_frame>baseline，4，8，12，27and 52 weeks</time_frame>
    <description>cognitive function improvement will be measured by Cogstate system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression level change</measure>
    <time_frame>baseline，4，8，12，27and 52 weeks</time_frame>
    <description>depression level will be measured by patient health questionnaire-9(PHQ-9). The Patient Health Questionnaire (PHQ) is a multiple-choice self-report inventory, and The PHQ-9 is a tool specific to depression which has 9 items. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety level change</measure>
    <time_frame>baseline，4，8，12，27and 52 weeks</time_frame>
    <description>anxiety level will be measured by Generalized Anxiety Disorder(GAD-7). it has 7 items and measure severity of various signs of GAD according to reported response categories with assigned points. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>addiction severity change</measure>
    <time_frame>baseline，4，8，12，27and 52 weeks</time_frame>
    <description>addiction severity will be measured by addiction severity index(ASI). ASI is a semi-structured instrument used in face-to-face interviews conducted by clinicians, researchers or trained techniciansIt measures Medical issues relating to drug use, Employment/Support Status, Levels of Alcohol and Drug Use, Legal Issues Arising from Substance Abuse, Family/Social Factors and Psychiatric/Mental Health Status. Severity ratings are based on the following 10 point scale (0-9).0-1: No real problem, treatment not indicated, 2-3: Slight problem, treatment probably not necessary 4-5: Moderate problem, some treatment indicated 6-7: Considerable problem, treatment necessary 8-9: Extreme problem, treatment absolutely necessary</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Methamphetamine-dependence</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>an 8-session mindfulness-based relapse prevention program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mindfulness-based relapse prevention</intervention_name>
    <description>mindfulness-based relapse prevention, 8 weeks</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years old, male or female, with 9 years of education or above, can cooperate&#xD;
             with the completion of the questionnaire evaluation;&#xD;
&#xD;
          -  Comply with DSM-V diagnostic criteria for amphetamine-based addiction;&#xD;
&#xD;
          -  The previous use of amphetamines for not less than 1 year (at least once a week);&#xD;
&#xD;
          -  Vision and hearing are normal, or in the normal range after correction. No&#xD;
             contraindications for magnetic resonance imaging;&#xD;
&#xD;
          -  agree to cooperate with the completion of follow-up evaluation;&#xD;
&#xD;
          -  The Mindfulness Attention Awareness Scale score is greater than 50 points.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive dysfunction, such as history of head trauma, cerebrovascular disease,&#xD;
             epilepsy, etc., drugs used to promote cognitive function in the last 6 months;&#xD;
             intellectual impairment IQ&lt;70;&#xD;
&#xD;
          -  There have been other abuse or dependence of psychoactive substances in the past 5&#xD;
             years (excluding nicotine); 100 healthy controls have been publicly collected by the&#xD;
             public. Exclude serious physical illness and mental damage. through&#xD;
&#xD;
          -  SCID clinical interviews exclude family history of mental disorders and psychosis, no&#xD;
             history of substance abuse (except nicotine).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jiang DU, Doctor</last_name>
    <phone>021-64906315</phone>
    <email>dujiangdou@163.com</email>
  </overall_contact>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>October 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 8, 2020</last_update_submitted>
  <last_update_submitted_qc>January 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mindfulness-based relapse prevention</keyword>
  <keyword>methamphetamine</keyword>
  <keyword>Prefrontal-striatal circuit</keyword>
  <keyword>impulsive</keyword>
  <keyword>mechanism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Impulsive Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03748875
org study id: JDu-006
nct id: NCT03748875
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Amphetamine-type stimulants (ATSs) have become the most important medical issue as well as
      the social problem. Compared with traditional drugs, ATS are highly neurotoxin and can induce
      cognitive deficit and psychotic symptoms. Due to lack of efficient medical treatment,
      psychotherapy and behavioral interventions are the main treatment strategies so far.
      Mindful-based relapse prevention (MBRP) which combined mindfulness with relapse prevention
      skills, as a novel intervention, has been widely used in prevent craving and relapse among
      addictions. While the current research of MBRP mechanism focus on emotion regulation circuit,
      and there was no study to explore the impulsive circuit, which is the important factor that
      induce the addiction and relapse. However, there was no report about the influence of MBRP on
      Prefrontal-striatal circuits. Based on the previous results, the proposed study will focus on
      evaluating the mechanism of MBRP on prefrontal-striatal circuits, neuropsychological tests
      and functional MRI will be used to investigate the neurobiological mechanism of MBRP on
      prefrontal-striatal circuits and related impulsive behaviors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: craving change
time frame: change from baseline, 4，8，12，27and 52 weeks
description: craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving
measure: impulsiveness change
time frame: baseline，4，8，12，27and 52 weeks
description: impulsiveness will be measured by Barratt Impulsiveness Scale, the scale is a 30 item self-report measure, Rarely/Never = 1，Occasionally = 2，Often = 3，Almost Always/Always = 4. Assessment is indicated by the total score added together.
measure: functional connectivity change between prefrontal cortex and striatum
time frame: baseline, 8 and 12weeks
description: functional connectivity between prefrontal cortex and striatum will be measured by fMRI
measure: cognitive function improvement
time frame: baseline，4，8，12，27and 52 weeks
description: cognitive function improvement will be measured by Cogstate system
measure: depression level change
time frame: baseline，4，8，12，27and 52 weeks
description: depression level will be measured by patient health questionnaire-9(PHQ-9). The Patient Health Questionnaire (PHQ) is a multiple-choice self-report inventory, and The PHQ-9 is a tool specific to depression which has 9 items. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
measure: anxiety level change
time frame: baseline，4，8，12，27and 52 weeks
description: anxiety level will be measured by Generalized Anxiety Disorder(GAD-7). it has 7 items and measure severity of various signs of GAD according to reported response categories with assigned points. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).
measure: addiction severity change
time frame: baseline，4，8，12，27and 52 weeks
description: addiction severity will be measured by addiction severity index(ASI). ASI is a semi-structured instrument used in face-to-face interviews conducted by clinicians, researchers or trained techniciansIt measures Medical issues relating to drug use, Employment/Support Status, Levels of Alcohol and Drug Use, Legal Issues Arising from Substance Abuse, Family/Social Factors and Psychiatric/Mental Health Status. Severity ratings are based on the following 10 point scale (0-9).0-1: No real problem, treatment not indicated, 2-3: Slight problem, treatment probably not necessary 4-5: Moderate problem, some treatment indicated 6-7: Considerable problem, treatment necessary 8-9: Extreme problem, treatment absolutely necessary
arm group label: Intervention group
arm group type: Experimental
description: an 8-session mindfulness-based relapse prevention program
arm group label: Control group
arm group type: No Intervention
description: treatment as usual
intervention type: Behavioral
intervention name: mindfulness-based relapse prevention
description: mindfulness-based relapse prevention, 8 weeks
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiang DU, Doctor
phone: 021-64906315
email: dujiangdou@163.com
responsible party type: Sponsor
mesh term: Recurrence
mesh term: Impulsive Behavior
sharing ipd: Undecided