<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/NCT03827785</url>
  </required_header>
  <id_info>
    <org_study_id>HFJiang-002</org_study_id>
    <nct_id>NCT03827785</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence</brief_title>
  <official_title>The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wuxi Mental Health Center, Jiangsu Provence, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Suzhou Guangji Hospital, Jiangsu Provence, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Mental Health Center, Hubei Provence, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yunnan Institute For Drug Abuse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA)&#xD;
      addiction in previous studies, while the evidence-based protocols still required. The aim of&#xD;
      this research is to evaluating the effectiveness and safety of rTMS treatment in improving&#xD;
      the days of abstinence maintenance. In addition, treatment effect on cognitive impairment,&#xD;
      psychological craving and depression are also evaluated during the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First, a multicenter, double-blind, randomized control study is going to be carried out. 100&#xD;
      recruited patients will be randomized assigned to the intervention group and the control&#xD;
      group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS)&#xD;
      treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test&#xD;
      follow-up (1 time per week). Negative rate of urine test during the follow-up period is set&#xD;
      as primary outcome. Cognitive function, craving, depression are also evaluated before and&#xD;
      after the intervention.&#xD;
&#xD;
      Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each&#xD;
      group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential&#xD;
      neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an&#xD;
      evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of&#xD;
      relapse for both the patients and their families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 12, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Negative rate urine test</measure>
    <time_frame>12 weeks</time_frame>
    <description>After treatment, patients will be asked to participate urine test for 12 times once a week. Loss of visit or rejection for urine test will be treated as urine test positive.&#xD;
Negative rate of urine drug test = actual number of negative urine tests / 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Craving assessed by Visual Analog Scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function assessed by CogState Battery (CSB)</measure>
    <time_frame>12 weeks</time_frame>
    <description>evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression status assessed by Hamilton depression scale (HAMD-17)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Evaluate all participants' depression status by Hamilton depression scale (HAMD-17) HAMD can be summarized into 7 types of factor structure: (1) anxiety/somatization:; (2) weight: weight loss (3) Cognitive obstacles; (4) day and night changes; (5) Block; (6) sleep disorder; (7) feeling of despair. The total score can reflect the severity of the symptom, that is, The lighter the symptoms, the lower the score, and vice versa. Mild depression: HAMD 17 scores &gt; 7 points, ≤ 17 points; moderate depression: HAMD 17 scores &gt; 17 points, ≤ 24 points; severe depression: HAMD 17 scores &gt; 24 points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Methamphetamine-dependence</condition>
  <arm_group>
    <arm_group_label>rTMS treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham rTMS treatment group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Stimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS treatment group</intervention_name>
    <description>For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.</description>
    <arm_group_label>rTMS treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham rTMS treatment group</intervention_name>
    <description>For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.</description>
    <arm_group_label>sham rTMS treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)&#xD;
             for methamphetamine (MA) use disorders&#xD;
&#xD;
          2. Junior high school degree or above&#xD;
&#xD;
          3. Normal vision and hearing&#xD;
&#xD;
          4. Dextromanual&#xD;
&#xD;
          5. Less than one month before last drug use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a disease that affect cognitive function such as history of head injury,&#xD;
             cerebrovascular disease, epilepsy, etc&#xD;
&#xD;
          2. Have cognitive-promoting drugs in the last 6 months&#xD;
&#xD;
          3. Other substance abuse or dependence in recent five years (except nicotine)&#xD;
&#xD;
          4. Mental impairment, Intelligence Quotient (IQ) &lt; 70&#xD;
&#xD;
          5. Mental disorders&#xD;
&#xD;
          6. Physical disease&#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_official>
    <last_name>Haifeng Jiang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Rehabilitation Center</name>
      <address>
        <city>Shanghai</city>
        <zip>200010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>repetitive transcranial magnetic stimulation (rTMS)</keyword>
  <keyword>randomized clinical trials</keyword>
  <keyword>treatment</keyword>
  <keyword>craving</keyword>
  <keyword>cognitive function</keyword>
  <!-- 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/NCT03827785
org study id: HFJiang-002
nct id: NCT03827785
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA)
      addiction in previous studies, while the evidence-based protocols still required. The aim of
      this research is to evaluating the effectiveness and safety of rTMS treatment in improving
      the days of abstinence maintenance. In addition, treatment effect on cognitive impairment,
      psychological craving and depression are also evaluated during the study.
First, a multicenter, double-blind, randomized control study is going to be carried out. 100
      recruited patients will be randomized assigned to the intervention group and the control
      group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS)
      treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test
      follow-up (1 time per week). Negative rate of urine test during the follow-up period is set
      as primary outcome. Cognitive function, craving, depression are also evaluated before and
      after the intervention.

      Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each
      group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential
      neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an
      evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of
      relapse for both the patients and their families.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Negative rate urine test
time frame: 12 weeks
description: After treatment, patients will be asked to participate urine test for 12 times once a week. Loss of visit or rejection for urine test will be treated as urine test positive.
Negative rate of urine drug test = actual number of negative urine tests / 12.
measure: Change of Craving assessed by Visual Analog Scale
time frame: 12 weeks
description: evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
measure: Cognitive function assessed by CogState Battery (CSB)
time frame: 12 weeks
description: evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version
measure: Depression status assessed by Hamilton depression scale (HAMD-17)
time frame: 12 weeks
description: Evaluate all participants' depression status by Hamilton depression scale (HAMD-17) HAMD can be summarized into 7 types of factor structure: (1) anxiety/somatization:; (2) weight: weight loss (3) Cognitive obstacles; (4) day and night changes; (5) Block; (6) sleep disorder; (7) feeling of despair. The total score can reflect the severity of the symptom, that is, The lighter the symptoms, the lower the score, and vice versa. Mild depression: HAMD 17 scores > 7 points, ≤ 17 points; moderate depression: HAMD 17 scores > 17 points, ≤ 24 points; severe depression: HAMD 17 scores > 24 points.
arm group label: rTMS treatment group
arm group type: Experimental
description: Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days.
arm group label: sham rTMS treatment group
arm group type: Sham Comparator
description: Stimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days.
intervention type: Device
intervention name: rTMS treatment group
description: For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.
arm group label: rTMS treatment group
intervention type: Device
intervention name: sham rTMS treatment group
description: For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.
arm group label: sham rTMS treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haifeng Jiang
role: Principal Investigator
affiliation: Shanghai Mental Health Center
facility: 
country: China
responsible party type: Sponsor