Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endogenous Opioid Systems and Symptom Change in Fibromyalgia

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: NCT02866461
Recruitment Status : Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jon-Kar Zubieta, University of Utah

Brief 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.

Condition or disease Intervention/treatment
Fibromyalgia Other: No 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Endogenous Opioid Systems and Symptom Change in Fibromyalgia
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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




Primary Outcome Measures :
  1. change in mu opioid-mediated neurotransmission [ Time Frame: Change from baseline at 6 weeks ]
    assessed via PET scanning


Secondary Outcome Measures :
  1. change in Biomarkers of pain response [ Time Frame: Change from baseline at 6 weeks ]
    serum cortisol

  2. change in Biomarkers of pain response [ Time Frame: Change from 8 weeks at 14 weeks ]
    serum cortisol

  3. change in Pain [ Time Frame: Change from baseline at 6 weeks ]
    assessed via questionnaire

  4. change in Pain [ Time Frame: Change from 8 weeks at 14 weeks ]
    assessed via questionnaire

  5. change in mu opioid-mediated neurotransmission [ Time Frame: Change from 8 weeks at 14 weeks ]
    assessed via PET scanning


Biospecimen Retention:   Samples With DNA
Blood will be sampled at baseline to test for genes that may be associated with the function of the chemical signals between nerve cells, function of hormones, and symptoms. The genetic portion of the study is optional.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with Fibromyalgia
Criteria

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

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): NCT02866461


Contacts
Layout table for location contacts
Contact: Andrea White, PhD 801-587-1288 utahneuroimagelab@gmail.com
Contact: Jon-Kar Zubieta, MD, PhD 801-742-1517 utahneuroimagelab@gmail.com

Sponsors and Collaborators
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Jon-Kar Zubieta, MD, PhD University of Utah

Publications:

Layout table for additonal information
Responsible Party: Jon-Kar Zubieta, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT02866461     History of Changes
Other Study ID Numbers: R01 3589819
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Endorphins
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs