FibromyalgiaFIBRODOPANCT04451564
Understanding and Restoring Dopaminergic Function in Fibromyalgia Patients
A study testing Mindfulness oriented recovery enhancement in people with Fibromyalgia, run by University of Fribourg at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Mindfulness oriented recovery enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2021to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fibromyalgia syndrome
- no psychiatric disorders
- right handed
- older than 18 years,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Maya Burckhard contact
Switzerland1 site
University of Fribourg
Fribourg, 1700
Katharina ledermann, +41765330316 ext. +41765330316, katharina.ledermann@unifr.ch
Chantal martin Sölch, chantal.martinsoelch@unifr.ch
About this study
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
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Mindfulness oriented recovery enhancement
- Keywords
- dopamine, reward, F-DOPA, mindfulness
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness oriented recovery enhancementBehavioural
8- week psychological program based on mindfulness techniques
| Study group | Role | What they receive |
|---|---|---|
| MORE Mindfulness oriented recovery enhancement group | Experimental | MORE Mindfulness oriented recovery enhancement group Receives: Behavioral: Mindfulness oriented recovery enhancement |
| Control | No intervention | wait-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine response
Dopamine response measured with 18F-DOPA as percent Bold signal change Range 0.001 +/-0.009 ml g -1 per min
Measured: within the second year
Secondary outcomes (1)
changes in pain and clinical related measures
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
Measured: within the second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study startMar 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, University of Zurich, University of Utah
- Responsible party
- Sponsor
- Investigators
- Chantal o Martin Sölch, PhD, Principal investigator, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451564
- Sponsor's protocol ID
- FIBRODOPA TRIAL
- Acronym
- FIBRODOPA
- Status last verified
- Jan 2021
- First submitted
- 19 Jun 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35078536
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04451564
- Acronym / sponsor ID
- FIBRODOPA / FIBRODOPA TRIAL
- Conditions
- Fibromyalgia
- Keywords
- dopamine, reward, F-DOPA, mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Collaborators
- University of Lausanne, University of Zurich, University of Utah
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORE Mindfulness oriented recovery enhancement group | Experimental | Behavioral: Mindfulness oriented recovery enhancementMORE Mindfulness oriented recovery enhancement group |
| Control | No intervention | –wait-list |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fibromyalgia syndrome
- no psychiatric disorders
- right handed
- older than 18 years,
Key exclusion criteria (8 listed)
- male sex
- history of neurological disorders
- left handed
- psychiatric disorders
- current substance or tobacco abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness oriented recovery enhancement8- week psychological program based on mindfulness techniques | Behavioural | MORE Mindfulness oriented recovery enhancement group |
Primary outcome
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
1 secondary outcome
changes in pain and clinical related measures
Time frame: within the second year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 35078536Ledermann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Burckhard contact
Chantal o Martin Sölch, PhD principal investigator
University of Fribourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness oriented recovery enhancement in people with Fibromyalgia, run by University of Fribourg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact katharina Ledermann (+41765330316, katharina.ledermann@unifr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine response (time frame: within the second year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.