Endogenous Opioid Systems and Symptom Change in Fibromyalgia

April 12, 2023 updated by: University of Utah
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with Fibromyalgia

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • Impairments that would prevent completion of the study protocol;
  • Use of sleep aids at frequency of more that twice per week;
  • Allergy to fentanyl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fibromyalgia
No treatment
Other: No treatment
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in mu opioid-mediated neurotransmission
Time Frame: Change from baseline at 6 weeks
assessed via PET scanning
Change from baseline at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Biomarkers of pain response
Time Frame: Change from baseline at 6 weeks
serum cortisol
Change from baseline at 6 weeks
change in Biomarkers of pain response
Time Frame: Change from 8 weeks at 14 weeks
serum cortisol
Change from 8 weeks at 14 weeks
change in Pain
Time Frame: Change from baseline at 6 weeks
assessed via questionnaire
Change from baseline at 6 weeks
change in Pain
Time Frame: Change from 8 weeks at 14 weeks
assessed via questionnaire
Change from 8 weeks at 14 weeks
change in mu opioid-mediated neurotransmission
Time Frame: Change from 8 weeks at 14 weeks
assessed via PET scanning
Change from 8 weeks at 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01 3589819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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