<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/NCT04451564</url>
  </required_header>
  <id_info>
    <org_study_id>FIBRODOPA TRIAL</org_study_id>
    <nct_id>NCT04451564</nct_id>
  </id_info>
  <brief_title>Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients</brief_title>
  <acronym>FIBRODOPA</acronym>
  <official_title>Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients Using a Mindfulness-based Psychological Intervention: A [18F]-DOPA Positron Emissions Tomography (PET) Study Study Protocol for the FIBRODOPA Study- a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Fribourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lausanne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Fribourg</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fibromyalgia (FM) is a very prevalent and debilitating chronic pain disorder that is&#xD;
      difficult to treat. Mindfulness-based techniques are regarded as a very promising approach&#xD;
      for the treatment of chronic pain and in particular FM. The Mindfulness-Oriented Recovery&#xD;
      Enhancement (MORE) intervention, a mindfulness-based group intervention, has shown beneficial&#xD;
      effects in opioid-treated chronic pain patients, including reduced pain severity, functional&#xD;
      interference, and opioid dosing, by restoring neurophysiological and behavioral responses to&#xD;
      reward. First evidence for a hypodopaminergic state and impaired reward processing in FM have&#xD;
      been reported. However, little is known about its impact on dopamine (DA) function and in&#xD;
      particular with regard to DA responses to monetary reward in FM. The aim of the present study&#xD;
      protocol is to evaluate if MORE is able to restore the DA function in FM patients, in&#xD;
      particular with regard to the DA responses to reward, and to reduce pain and mood complaints&#xD;
      in FM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the present study is a multi-center randomized controlled trial (RCT) with 3 time points:&#xD;
      before the intervention, after completion of the intervention and 3-months after completion&#xD;
      of the intervention. Eighty FM patients will be randomly assigned to either the MORE&#xD;
      intervention (N=40) or to a wait-list control group (N=40). Additionally a comparison group&#xD;
      of healthy women (N=20) will be enrolled. The MORE intervention consists of eight 2-hour long&#xD;
      group sessions administered weekly over a period of 8 weeks. Before and after the&#xD;
      intervention, FM participants will undergo [18F] DOPA Positron Emission Tomography (PET) and&#xD;
      functional magnetic resonance (MR) imaging while performing a monetary reward task. The&#xD;
      primary outcome will be endogeneous DA changes measured with [18F] DOPA PET at baseline,&#xD;
      after the intervention (after 8 weeks for control group), and at 3 months' follow-up.&#xD;
      Secondary outcomes will be (1) clinical pain measures and FM symptoms using standardized&#xD;
      clinical scales 2) functional brain changes 3) measures of negative and positive affect,&#xD;
      stress and reward experience in daily life using the Experience Sampling method (ESM) 4)&#xD;
      biological measures of stress including cortisol and alpha-amylase.&#xD;
&#xD;
      Design: If the findings of this study confirm the effectiveness of MORE in restoring DA&#xD;
      function, reducing pain and improving mood symptoms, MORE can be judged to be a promising&#xD;
      means to improve quality of life in FM patients. The findings of this trial may inform health&#xD;
      care providers about the potential use of the MORE intervention as a possible&#xD;
      non-pharmacological intervention for FM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 2021</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dopamine response</measure>
    <time_frame>within the second year</time_frame>
    <description>Dopamine response measured with 18F-DOPA as percent Bold signal change Range 0.001 +/-0.009 ml g -1 per min</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in pain and clinical related measures</measure>
    <time_frame>within the second year</time_frame>
    <description>measured with the brief pain inventory questionnaire (BPI, Cleeland, 1994) Range: 0-40. 0 corresponds to no interference with pain in daily life and 40 corresponds to maximal interference of pain in daily life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>MORE Mindfulness oriented recovery enhancement group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MORE Mindfulness oriented recovery enhancement group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>wait-list</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness oriented recovery enhancement</intervention_name>
    <description>8- week psychological program based on mindfulness techniques</description>
    <arm_group_label>MORE Mindfulness oriented recovery enhancement group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fibromyalgia syndrome&#xD;
&#xD;
          -  no psychiatric disorders&#xD;
&#xD;
          -  right handed&#xD;
&#xD;
          -  older than 18 years,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  male sex&#xD;
&#xD;
          -  history of neurological disorders&#xD;
&#xD;
          -  left handed&#xD;
&#xD;
          -  psychiatric disorders&#xD;
&#xD;
          -  current substance or tobacco abuse&#xD;
&#xD;
          -  current and past substance dependence&#xD;
&#xD;
          -  schizophrenia spectrum disorder&#xD;
&#xD;
          -  any other form of chronic pain apart from Fibromyalgia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chantal o Martin Sölch, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Fribourg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>katharina Ledermann</last_name>
    <phone>+41765330316</phone>
    <email>katharina.ledermann@unifr.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maya Burckhard</last_name>
    <email>maya.burkhard@unifr.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Fribourg</name>
      <address>
        <city>Fribourg</city>
        <zip>1700</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <contact>
      <last_name>Katharina ledermann</last_name>
      <phone>+41765330316</phone>
      <phone_ext>+41765330316</phone_ext>
      <email>katharina.ledermann@unifr.ch</email>
    </contact>
    <contact_backup>
      <last_name>Chantal martin Sölch</last_name>
      <email>chantal.martinsoelch@unifr.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dopamine</keyword>
  <keyword>reward</keyword>
  <keyword>F-DOPA</keyword>
  <keyword>mindfulness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04451564
org study id: FIBRODOPA TRIAL
nct id: NCT04451564
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fibromyalgia (FM) is a very prevalent and debilitating chronic pain disorder that is
      difficult to treat. Mindfulness-based techniques are regarded as a very promising approach
      for the treatment of chronic pain and in particular FM. The Mindfulness-Oriented Recovery
      Enhancement (MORE) intervention, a mindfulness-based group intervention, has shown beneficial
      effects in opioid-treated chronic pain patients, including reduced pain severity, functional
      interference, and opioid dosing, by restoring neurophysiological and behavioral responses to
      reward. First evidence for a hypodopaminergic state and impaired reward processing in FM have
      been reported. However, little is known about its impact on dopamine (DA) function and in
      particular with regard to DA responses to monetary reward in FM. The aim of the present study
      protocol is to evaluate if MORE is able to restore the DA function in FM patients, in
      particular with regard to the DA responses to reward, and to reduce pain and mood complaints
      in FM.
the present study is a multi-center randomized controlled trial (RCT) with 3 time points:
      before the intervention, after completion of the intervention and 3-months after completion
      of the intervention. Eighty FM patients will be randomly assigned to either the MORE
      intervention (N=40) or to a wait-list control group (N=40). Additionally a comparison group
      of healthy women (N=20) will be enrolled. The MORE intervention consists of eight 2-hour long
      group sessions administered weekly over a period of 8 weeks. Before and after the
      intervention, FM participants will undergo [18F] DOPA Positron Emission Tomography (PET) and
      functional magnetic resonance (MR) imaging while performing a monetary reward task. The
      primary outcome will be endogeneous DA changes measured with [18F] DOPA PET at baseline,
      after the intervention (after 8 weeks for control group), and at 3 months' follow-up.
      Secondary outcomes will be (1) clinical pain measures and FM symptoms using standardized
      clinical scales 2) functional brain changes 3) measures of negative and positive affect,
      stress and reward experience in daily life using the Experience Sampling method (ESM) 4)
      biological measures of stress including cortisol and alpha-amylase.

      Design: If the findings of this study confirm the effectiveness of MORE in restoring DA
      function, reducing pain and improving mood symptoms, MORE can be judged to be a promising
      means to improve quality of life in FM patients. The findings of this trial may inform health
      care providers about the potential use of the MORE intervention as a possible
      non-pharmacological intervention for FM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Dopamine response
time frame: within the second year
description: Dopamine response measured with 18F-DOPA as percent Bold signal change Range 0.001 +/-0.009 ml g -1 per min
measure: changes in pain and clinical related measures
time frame: within the second year
description: measured with the brief pain inventory questionnaire (BPI, Cleeland, 1994) Range: 0-40. 0 corresponds to no interference with pain in daily life and 40 corresponds to maximal interference of pain in daily life
arm group label: MORE Mindfulness oriented recovery enhancement group
arm group type: Experimental
description: MORE Mindfulness oriented recovery enhancement group
arm group label: Control
arm group type: No Intervention
description: wait-list
intervention type: Behavioral
intervention name: Mindfulness oriented recovery enhancement
description: 8- week psychological program based on mindfulness techniques
arm group label: MORE Mindfulness oriented recovery enhancement group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chantal o Martin Sölch, PhD
role: Principal Investigator
affiliation: University of Fribourg
last name: katharina Ledermann
phone: +41765330316
email: katharina.ledermann@unifr.ch
last name: Maya Burckhard
email: maya.burkhard@unifr.ch
facility: 
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No