NCT02866461

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
5.2 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

March 22, 2016

Last Update Submit

April 12, 2023

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • change in mu opioid-mediated neurotransmission

    assessed via PET scanning

    Change from baseline at 6 weeks

Secondary Outcomes (5)

  • change in Biomarkers of pain response

    Change from baseline at 6 weeks

  • change in Biomarkers of pain response

    Change from 8 weeks at 14 weeks

  • change in Pain

    Change from baseline at 6 weeks

  • change in Pain

    Change from 8 weeks at 14 weeks

  • change in mu opioid-mediated neurotransmission

    Change from 8 weeks at 14 weeks

Study Arms (1)

Fibromyalgia

No treatment

Other: No treatment

Interventions

No treatmentOTHER

Observation

Fibromyalgia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with Fibromyalgia

You may qualify if:

  • 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
  • years of age
  • right handed
  • capable of providing written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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: 17050717BACKGROUND

  • 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: 17855614BACKGROUND

  • 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: 19501658BACKGROUND

  • 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: 24027273BACKGROUND

  • 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: 24760847BACKGROUND

  • 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.

    PMID: 26156996BACKGROUND

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.

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases
0

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

August 15, 2016

Study Start

November 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share