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Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients (FIBRODOPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451564
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
University of Lausanne
University of Zurich
University of Utah
Information provided by (Responsible Party):
University of Fribourg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Mindfulness oriented recovery enhancement Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: MORE Mindfulness oriented recovery enhancement group
MORE Mindfulness oriented recovery enhancement group
Behavioral: Mindfulness oriented recovery enhancement
8- week psychological program based on mindfulness techniques

No Intervention: Control
wait-list



Primary Outcome Measures :
  1. Dopamine response [ Time Frame: within the second year ]
    Dopamine response measured with 18F-DOPA as percent Bold signal change Range 0.001 +/-0.009 ml g -1 per min


Secondary Outcome Measures :
  1. changes in pain and clinical related measures [ Time Frame: within the second year ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fibromyalgia syndrome
  • no psychiatric disorders
  • right handed
  • older than 18 years,

Exclusion Criteria:

  • male sex
  • history of neurological disorders
  • left handed
  • psychiatric disorders
  • current substance or tobacco abuse
  • current and past substance dependence
  • schizophrenia spectrum disorder
  • any other form of chronic pain apart from Fibromyalgia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451564


Contacts
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Contact: katharina Ledermann +41765330316 katharina.ledermann@unifr.ch
Contact: Maya Burckhard maya.burkhard@unifr.ch

Locations
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Switzerland
University of Fribourg
Fribourg, Switzerland, 1700
Contact: Katharina ledermann    +41765330316 ext +41765330316    katharina.ledermann@unifr.ch   
Contact: Chantal martin Sölch       chantal.martinsoelch@unifr.ch   
Sponsors and Collaborators
University of Fribourg
University of Lausanne
University of Zurich
University of Utah
Investigators
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Principal Investigator: Chantal o Martin Sölch, PhD University of Fribourg
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Responsible Party: University of Fribourg
ClinicalTrials.gov Identifier: NCT04451564    
Other Study ID Numbers: FIBRODOPA TRIAL
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Fribourg:
dopamine
reward
F-DOPA
mindfulness
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases