<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/NCT03025321</url>
  </required_header>
  <id_info>
    <org_study_id>NL57262.078.16</org_study_id>
    <nct_id>NCT03025321</nct_id>
  </id_info>
  <brief_title>Effects of tDCS on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder</brief_title>
  <official_title>Effects of Electrical Neuromodulation on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder: A Multi-Session tDCS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation&#xD;
      (tDCS) over the dorsolateral prefrontal cortex (DLPFC) reduces craving and seems to decrease&#xD;
      relapse risk in addiction. However, little is known about the relapse rates in cocaine&#xD;
      addiction after tDCS, despite the need for neurobiological treatments to reduce the high&#xD;
      relapse rates in this population. The current study explores the effects of repetitive tDCS&#xD;
      in a larger sample (N=60) of cocaine addicted patients on number of relapse days after three&#xD;
      months. We expect that a decrease in relapse risk after tDCS is associated with cognitive&#xD;
      control functioning. Therefore, risky decision making and inhibitory control will be measured&#xD;
      before and after the interventions, and at three months follow-up. Ecological momentary&#xD;
      assessment (EMA) will be used as a reliable measure for relapse, craving and mood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, 60 cocaine addicted patients will receive real or sham bilateral tDCS (left&#xD;
      cathodal/right anodal) over the DLPFC after one week in detox. The participants will receive&#xD;
      this two times daily for 5 consecutive days. It is expected that this particular tDCS method&#xD;
      will reduce relapse probability, as was previously seen in alcohol addicted patients.&#xD;
      Furthermore, it is hypothesized that this therapeutic effect is associated with diminished&#xD;
      craving and enhanced cognitive control. Craving, temptations and relapse, will be explored by&#xD;
      means of Ecological Momentary Assessment (EMA). The mixed results in previous studies of tDCS&#xD;
      on craving may be explained by the fact that craving in addiction is a momentary phenomenon&#xD;
      which is difficult to reliably measure with more traditional methods like retrospective&#xD;
      self-reports, for which EMA provides a solution. Cognitive control will be measured by means&#xD;
      of inhibitory control during a Go/NoGo task and reward processing during a gambling task. The&#xD;
      tasks will be performed at baseline, one day after the tDCS sessions and at three months&#xD;
      follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">March 8, 2019</completion_date>
  <primary_completion_date type="Actual">November 26, 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of relapse days at three months follow-up</measure>
    <time_frame>three months</time_frame>
    <description>In an app on the smartphone participants can indicate when they relapsed at any time during 3 months starting from tDCS session 1. Participants will receive a reminder at the end of every week to fill this out.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of relapse days at one week after the last tDCS session</measure>
    <time_frame>2 weeks</time_frame>
    <description>In an app on the smartphone participants can indicate when they relapsed at any time during 2 weeks starting from tDCS session 1. Participants will receive a reminder at the end of every week to fill this out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>2 weeks</time_frame>
    <description>Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 2 weeks starting from tDCS session 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>2 weeks</time_frame>
    <description>Participants receive 4 prompts a day in the app on the smartphone to fill out questions about mood during 2 weeks starting from tDCS session 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibitory control</measure>
    <time_frame>at baseline and one day after tDCS and at three months follow-up</time_frame>
    <description>3 times measured by means of a cocaine related Go/NoGo task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reward processing</measure>
    <time_frame>at baseline and one day after tDCS and at three months follow-up</time_frame>
    <description>3 times measured by means of a gambling task</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Cocaine Addiction</condition>
  <arm_group>
    <arm_group_label>transcranial direct current stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for five consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial Direct Current Stimulation (tDCS)</intervention_name>
    <description>tDCS is an electrical brain stimulation method Participants will receive real-tDCS or sham twice daily for 13 min with an interval of 20 min for five consecutive days.</description>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_label>transcranial direct current stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 65 years&#xD;
&#xD;
          -  Meeting the DSM-V criteria for cocaine dependence&#xD;
&#xD;
          -  The ability to speak, read, and write in Dutch at an eight-grade literacy level&#xD;
&#xD;
          -  No severe withdrawal signs or symptoms at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indications of severe psychopathology (psychosis, severe mood disorder) as assessed by&#xD;
             a physician&#xD;
&#xD;
          -  A diagnosis of epilepsy, convulsions or delirium tremens during abstinence of cocaine&#xD;
             use&#xD;
&#xD;
          -  Any contraindication for electrical brain stimulation procedures such as electronic&#xD;
             implants or metal implants&#xD;
&#xD;
          -  Pregnancy or breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Antes</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Ingmar Franken</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Cocaine</keyword>
  <keyword>tDCS</keyword>
  <keyword>EMA</keyword>
  <keyword>Inhibitory control</keyword>
  <keyword>Reward processing</keyword>
  <keyword>Addiction</keyword>
  <keyword>dlPFC</keyword>
  <keyword>craving</keyword>
  <keyword>cognitive control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <!-- 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/NCT03025321
org study id: NL57262.078.16
nct id: NCT03025321
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation
      (tDCS) over the dorsolateral prefrontal cortex (DLPFC) reduces craving and seems to decrease
      relapse risk in addiction. However, little is known about the relapse rates in cocaine
      addiction after tDCS, despite the need for neurobiological treatments to reduce the high
      relapse rates in this population. The current study explores the effects of repetitive tDCS
      in a larger sample (N=60) of cocaine addicted patients on number of relapse days after three
      months. We expect that a decrease in relapse risk after tDCS is associated with cognitive
      control functioning. Therefore, risky decision making and inhibitory control will be measured
      before and after the interventions, and at three months follow-up. Ecological momentary
      assessment (EMA) will be used as a reliable measure for relapse, craving and mood.
For this study, 60 cocaine addicted patients will receive real or sham bilateral tDCS (left
      cathodal/right anodal) over the DLPFC after one week in detox. The participants will receive
      this two times daily for 5 consecutive days. It is expected that this particular tDCS method
      will reduce relapse probability, as was previously seen in alcohol addicted patients.
      Furthermore, it is hypothesized that this therapeutic effect is associated with diminished
      craving and enhanced cognitive control. Craving, temptations and relapse, will be explored by
      means of Ecological Momentary Assessment (EMA). The mixed results in previous studies of tDCS
      on craving may be explained by the fact that craving in addiction is a momentary phenomenon
      which is difficult to reliably measure with more traditional methods like retrospective
      self-reports, for which EMA provides a solution. Cognitive control will be measured by means
      of inhibitory control during a Go/NoGo task and reward processing during a gambling task. The
      tasks will be performed at baseline, one day after the tDCS sessions and at three months
      follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of relapse days at three months follow-up
time frame: three months
description: In an app on the smartphone participants can indicate when they relapsed at any time during 3 months starting from tDCS session 1. Participants will receive a reminder at the end of every week to fill this out.
measure: Number of relapse days at one week after the last tDCS session
time frame: 2 weeks
description: In an app on the smartphone participants can indicate when they relapsed at any time during 2 weeks starting from tDCS session 1. Participants will receive a reminder at the end of every week to fill this out.
measure: Craving
time frame: 2 weeks
description: Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 2 weeks starting from tDCS session 1
measure: Mood
time frame: 2 weeks
description: Participants receive 4 prompts a day in the app on the smartphone to fill out questions about mood during 2 weeks starting from tDCS session 1
measure: Inhibitory control
time frame: at baseline and one day after tDCS and at three months follow-up
description: 3 times measured by means of a cocaine related Go/NoGo task
measure: Reward processing
time frame: at baseline and one day after tDCS and at three months follow-up
description: 3 times measured by means of a gambling task
arm group label: transcranial direct current stimulation
arm group type: Experimental
description: This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for five consecutive days.
arm group label: Sham tDCS
arm group type: Sham Comparator
description: The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
intervention type: Device
intervention name: transcranial Direct Current Stimulation (tDCS)
description: tDCS is an electrical brain stimulation method Participants will receive real-tDCS or sham twice daily for 13 min with an interval of 20 min for five consecutive days.
arm group label: Sham tDCS
arm group label: transcranial direct current stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Ingmar Franken
investigator title: Prof. Dr.
mesh term: Cocaine-Related Disorders
mesh term: Behavior, Addictive