Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT02866461
Status:
WITHDRAWN
Last Update Posted:
2023-04-18
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endogenous Opioid Systems and Symptom Change in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': '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 Project was transferred to another institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2016-03-22', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in mu opioid-mediated neurotransmission', 'timeFrame': 'Change from baseline at 6 weeks', 'description': 'assessed via PET scanning'}], 'secondaryOutcomes': [{'measure': 'change in Biomarkers of pain response', 'timeFrame': 'Change from baseline at 6 weeks', 'description': 'serum cortisol'}, {'measure': 'change in Biomarkers of pain response', 'timeFrame': 'Change from 8 weeks at 14 weeks', 'description': 'serum cortisol'}, {'measure': 'change in Pain', 'timeFrame': 'Change from baseline at 6 weeks', 'description': 'assessed via questionnaire'}, {'measure': 'change in Pain', 'timeFrame': 'Change from 8 weeks at 14 weeks', 'description': 'assessed via questionnaire'}, {'measure': 'change in mu opioid-mediated neurotransmission', 'timeFrame': 'Change from 8 weeks at 14 weeks', 'description': 'assessed via PET scanning'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '17050717', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17855614', 'type': 'BACKGROUND', 'citation': 'Harris 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.'}, {'pmid': '19501658', 'type': 'BACKGROUND', 'citation': 'Harris 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.'}, {'pmid': '24027273', 'type': 'BACKGROUND', 'citation': 'Martikainen 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.'}, {'pmid': '24760847', 'type': 'BACKGROUND', 'citation': 'Pecina 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.'}, {'pmid': '26156996', 'type': 'BACKGROUND', 'citation': 'Martikainen 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nEighty 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.\n\nVolunteers 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals diagnosed with Fibromyalgia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have met American College of Rheumatology (ACR) criteria for fibromyalgia for at least 1 year;\n* Willing to limit introduction of new treatments during the study;\n* Use of sleep aids no more than twice per week\n* 18-55 years of age\n* right handed\n* capable of providing written informed consent\n\nExclusion Criteria:\n\n* concurrent untreated medical illnesses, autoimmune, or inflammatory disease;\n* Routine daily use of narcotic analgesics or history of substance abuse;\n* Concurrent participation in other therapeutic trials;\n* Pregnancy/ nursing;\n* Ongoing psychiatric illness;\n* Contraindications to PET or MRI methods;\n* Impairments that would prevent completion of the study protocol;\n* Use of sleep aids at frequency of more that twice per week;\n* Allergy to fentanyl'}, 'identificationModule': {'nctId': 'NCT02866461', 'briefTitle': 'Endogenous Opioid Systems and Symptom Change in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Endogenous Opioid Systems and Symptom Change in Fibromyalgia', 'orgStudyIdInfo': {'id': 'R01 3589819'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibromyalgia', 'description': 'No treatment', 'interventionNames': ['Other: No treatment']}], 'interventions': [{'name': 'No treatment', 'type': 'OTHER', 'description': 'Observation', 'armGroupLabels': ['Fibromyalgia']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}