Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients
FIBRODOPA
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJanuary 13, 2021
January 1, 2021
1.8 years
June 19, 2020
January 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dopamine response
Dopamine response measured with 18F-DOPA as percent Bold signal change Range 0.001 +/-0.009 ml g -1 per min
within the second year
Secondary Outcomes (1)
changes in pain and clinical related measures
within the second year
Study Arms (2)
MORE Mindfulness oriented recovery enhancement group
EXPERIMENTALMORE Mindfulness oriented recovery enhancement group
Control
NO INTERVENTIONwait-list
Interventions
8- week psychological program based on mindfulness techniques
Eligibility Criteria
You may qualify if:
- Fibromyalgia syndrome
- no psychiatric disorders
- right handed
- older than 18 years,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Fribourglead
- University of Lausannecollaborator
- University of Zurichcollaborator
- University of Utahcollaborator
Study Sites (1)
University of Fribourg
Fribourg, 1700, Switzerland
Related Publications (1)
Ledermann K, von Kanel R, Berna C, Sprott H, Burckhardt M, Jenewein J, Garland EL, Martin-Solch C. Understanding and restoring dopaminergic function in fibromyalgia patients using a mindfulness-based psychological intervention: a [18F]-DOPA PET study. Study protocol for the FIBRODOPA study-a randomized controlled trial. Trials. 2021 Dec 1;22(1):864. doi: 10.1186/s13063-021-05798-1.
PMID: 35078536DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chantal o Martin Sölch, PhD
University of Fribourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 30, 2020
Study Start
March 1, 2021
Primary Completion
January 1, 2023
Study Completion
January 1, 2024
Last Updated
January 13, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share