FibromyalgiaNCT02866461
Endogenous Opioid Systems and Symptom Change in Fibromyalgia
An observational study of Fibromyalgia, run by University of Utah.
Trial summary
This study is designed to study brain mechanisms associated with symptoms and severity of Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported and objective measures of disease severity. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- No treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Aug 2023
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals diagnosed with Fibromyalgia
Who may be able to join
- Have met American College of Rheumatology (ACR) criteria for fibromyalgia for at least 1 year;
- Willing to limit introduction of new treatments during the study;
- Use of sleep aids no more than twice per week
- 18-55 years of age
- right handed
- capable of providing written informed consent
Who cannot join
- concurrent untreated medical illnesses, autoimmune, or inflammatory disease;
- Routine daily use of narcotic analgesics or history of substance abuse;
- Concurrent participation in other therapeutic trials;
- Pregnancy/ nursing;
- Ongoing psychiatric illness;
- Contraindications to PET or MRI methods;
Show all 9Show fewer
- Impairments that would prevent completion of the study protocol;
- Use of sleep aids at frequency of more that twice per week;
- Allergy to fentanyl
About this study
This study is designed to study brain mechanisms associated with symptoms and severity of Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported and objective measures of disease severity.
Read the detailed description
The purpose of this study is to examine µ-opioid receptor (µOR)-mediated neurotransmission in patients diagnosed with persistent pain, fibromyalgia (FM), and its relationship with pain and affect measures. µOR activation is expected to take place in the following brain regions: rostral and dorsal anterior cingulate (rACC, dACC), orbitofrontal cortex (OFC), thalamus (THA), nucleus accumbens (NAC), amygdala (AMY), periaqueductal gray (PAG). Greater regional activation is expected to be associated with improvements in clinical pain ratings and affective state.
The endogenous opioid system and µ-opioid receptors (µORs) play a central role in the regulation of pain, the pathophysiology of chronic pain syndromes, mood and emotion; this system is dysregulated in persistent pain syndromes. A substantial body of literature addressing these mechanisms has been developed in our laboratory, including recent data on the cognitive and molecular mechanisms associated with reductions in pain, as well as trait personality and genetic predictors of emotional effects in the context of pain.
Eighty individuals who have been diagnosed with FM and who fit the inclusion and exclusion criteria will be enrolled in this 14-week protocol. An initial visit for informed consent procedures and baseline characterization will then be scheduled, as well as the visits for positron emission tomography (PET) and magnetic resonance imaging (MRI) procedures. Subjects will return for testing after 6 and 14 weeks.
Volunteers will undergo imaging with structural and functional MRI and PET with [11C]carfentanil to determine baseline µOR non-displaceable binding potential (BPND) and changes in those BPND measures coinciding with symptom severity at the time of scanning.
- Conditions
- Fibromyalgia
- Being tested
- No treatment
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatmentOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | No treatment Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mu opioid-mediated neurotransmission
assessed via PET scanning
Measured: Change from baseline at 6 weeks
Secondary outcomes (5)
change in Biomarkers of pain response
serum cortisol
Measured: Change from baseline at 6 weeks
change in Biomarkers of pain response
serum cortisol
Measured: Change from 8 weeks at 14 weeks
change in Pain
assessed via questionnaire
Measured: Change from baseline at 6 weeks
change in Pain
assessed via questionnaire
Measured: Change from 8 weeks at 14 weeks
change in mu opioid-mediated neurotransmission
assessed via PET scanning
Measured: Change from 8 weeks at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startNov 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: It was not possible to conduct this study at the University of Utah due to the inability of the PET research facility to synthesize the radiotracer central to this project. Project was transferred to another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866461
- Sponsor's protocol ID
- R01 3589819
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Scott DJ, Heitzeg MM, Koeppe RA, Stohler CS, Zubieta JK. Variations in the human pain stress experience mediated by ventral and dorsal basal ganglia dopamine activity. J Neurosci. 2006 Oct 18;26(42):10789-95. doi: 10.1523/JNEUROSCI.2577-06.2006.
PubMed 17050717Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007.
PubMed 17855614Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6.
PubMed 19501658Martikainen IK, Pecina M, Love TM, Nuechterlein EB, Cummiford CM, Green CR, Harris RE, Stohler CS, Zubieta JK. Alterations in endogenous opioid functional measures in chronic back pain. J Neurosci. 2013 Sep 11;33(37):14729-37. doi: 10.1523/JNEUROSCI.1400-13.2013.
PubMed 24027273Pecina M, Martinez-Jauand M, Love T, Heffernan J, Montoya P, Hodgkinson C, Stohler CS, Goldman D, Zubieta JK. Valence-specific effects of BDNF Val66Met polymorphism on dopaminergic stress and reward processing in humans. J Neurosci. 2014 Apr 23;34(17):5874-81. doi: 10.1523/JNEUROSCI.2152-13.2014.
PubMed 24760847Martikainen IK, Nuechterlein EB, Pecina M, Love TM, Cummiford CM, Green CR, Stohler CS, Zubieta JK. Chronic Back Pain Is Associated with Alterations in Dopamine Neurotransmission in the Ventral Striatum. J Neurosci. 2015 Jul 8;35(27):9957-65. doi: 10.1523/JNEUROSCI.4605-14.2015.
PubMed 26156996
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Opioid Systems and Symptom Change in Fibromyalgia
- ClinicalTrials.gov ID
- NCT02866461
- Acronym / sponsor ID
- R01 3589819
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: It was not possible to conduct this study at the University of Utah due to the inability of the PET research facility to synthesize the radiotracer central to this project. Project was transferred to another institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- 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.
This study is designed to study brain mechanisms associated with symptoms and severity of Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported and objective measures of disease severity.
Detailed description
The purpose of this study is to examine µ-opioid receptor (µOR)-mediated neurotransmission in patients diagnosed with persistent pain, fibromyalgia (FM), and its relationship with pain and affect measures. µOR activation is expected to take place in the following brain regions: rostral and dorsal anterior cingulate (rACC, dACC), orbitofrontal cortex (OFC), thalamus (THA), nucleus accumbens (NAC), amygdala (AMY), periaqueductal gray (PAG). Greater regional activation is expected to be associated with improvements in clinical pain ratings and affective state.
The endogenous opioid system and µ-opioid receptors (µORs) play a central role in the regulation of pain, the pathophysiology of chronic pain syndromes, mood and emotion; this system is dysregulated in persistent pain syndromes. A substantial body of literature addressing these mechanisms has been developed in our laboratory, including recent data on the cognitive and molecular mechanisms associated with reductions in pain, as well as trait personality and genetic predictors of emotional effects in the context of pain.
Eighty individuals who have been diagnosed with FM and who fit the inclusion and exclusion criteria will be enrolled in this 14-week protocol. An initial visit for informed consent procedures and baseline characterization will then be scheduled, as well as the visits for positron emission tomography (PET) and magnetic resonance imaging (MRI) procedures. Subjects will return for testing after 6 and 14 weeks.
Volunteers will undergo imaging with structural and functional MRI and PET with [11C]carfentanil to determine baseline µOR non-displaceable binding potential (BPND) and changes in those BPND measures coinciding with symptom severity at the time of scanning.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | Other: No treatmentNo treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals diagnosed with Fibromyalgia
Key inclusion criteria (6 listed)
- Have met American College of Rheumatology (ACR) criteria for fibromyalgia for at least 1 year;
- Willing to limit introduction of new treatments during the study;
- Use of sleep aids no more than twice per week
- 18-55 years of age
- right handed
Key exclusion criteria (9 listed)
- concurrent untreated medical illnesses, autoimmune, or inflammatory disease;
- Routine daily use of narcotic analgesics or history of substance abuse;
- Concurrent participation in other therapeutic trials;
- Pregnancy/ nursing;
- Ongoing psychiatric illness;
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 |
|---|---|---|
| No treatmentObservation | Other | Fibromyalgia |
Primary outcome
change in mu opioid-mediated neurotransmission
Time frame: Change from baseline at 6 weeks
assessed via PET scanning
5 secondary outcomes
change in Biomarkers of pain response
Time frame: Change from baseline at 6 weeks
change in Biomarkers of pain response
Time frame: Change from 8 weeks at 14 weeks
change in Pain
Time frame: Change from baseline at 6 weeks
change in Pain
Time frame: Change from 8 weeks at 14 weeks
change in mu opioid-mediated neurotransmission
Time frame: Change from 8 weeks at 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 17050717Scott DJ, Heitzeg MM, Koeppe RA, Stohler CS, Zubieta JK. Variations in the human pain stress experience mediated by ventral and dorsal basal ganglia dopamine activity. J Neurosci. 2006 Oct 18;26(42):10789-95. doi: 10.1523/JNEUROSCI.2577-06.2006.
- Background: PubMed 17855614Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007.
- Background: PubMed 19501658Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6.
- Background: PubMed 24027273Martikainen IK, Pecina M, Love TM, Nuechterlein EB, Cummiford CM, Green CR, Harris RE, Stohler CS, Zubieta JK. Alterations in endogenous opioid functional measures in chronic back pain. J Neurosci. 2013 Sep 11;33(37):14729-37. doi: 10.1523/JNEUROSCI.1400-13.2013.
- Background: PubMed 24760847Pecina M, Martinez-Jauand M, Love T, Heffernan J, Montoya P, Hodgkinson C, Stohler CS, Goldman D, Zubieta JK. Valence-specific effects of BDNF Val66Met polymorphism on dopaminergic stress and reward processing in humans. J Neurosci. 2014 Apr 23;34(17):5874-81. doi: 10.1523/JNEUROSCI.2152-13.2014.
- Background: PubMed 26156996Martikainen IK, Nuechterlein EB, Pecina M, Love TM, Cummiford CM, Green CR, Stohler CS, Zubieta JK. Chronic Back Pain Is Associated with Alterations in Dopamine Neurotransmission in the Ventral Striatum. J Neurosci. 2015 Jul 8;35(27):9957-65. doi: 10.1523/JNEUROSCI.4605-14.2015.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by University of Utah.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mu opioid-mediated neurotransmission (time frame: Change from baseline at 6 weeks). 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 NCT02866461, which also lists 6 linked publications.
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 18 Apr 2023.