Inform Trial

Inform Clinical Trial

Trial Overview

Fibromyalgia (FMS) is a common chronic pain syndrome that is disabling to patients and costly to the society. FMS is devastating to the individual’s quality of life and family members. Despite intense research, what causes fibromyalgia is poorly understood and no single therapy is found to be beneficial to all patients.

The primary goal of this study is to evaluate the effect of low dose diabetes medication, metformin, on fibromyalgia symptoms. This study is funded by the National Institute of Health. All participants will be screened for eligibility and those who complete the entire study will be compensated for their time.

Participants will attend four separate study visits. During the initial visit, participants will undergo an initial health screening, fill out several questionnaires assessing symptoms related to quality of life and Fibromyalgia symptoms. Participants of childbearing years will be required to take a pregnancy test. Additionally, all participants will be required to have blood draw for general health. Between the first and second visits participants will be required to take a survey for 1 week on their phone to assess their fibromyalgia symptoms. At the 2nd visit, participants will receive metformin or placebo medication and be asked to take it once a day for 4 weeks. After four weeks, participants will return to the clinic for the 3rd visit. Participants will complete some questionnaires and have their blood drawn again for the study. They will receive another 4 weeks of medication or placebo to take for 4 additional weeks. One week prior to completing the study they will complete the same survey they did on their phone previously for one week. At the 4th and final visit participants will fill out the same questionnaires they completed at the initial visit and have their blood drawn again for the study. From the initial screening visit to the final visit, the study will take approximately 9 weeks.

Investigators

Principal Investigator: Norman Taylor, MD, PhD
Co-Investigator: Akiko Okifuji, PhD

Contact

For more information about whether you qualify to participate in this trial, please contact the study coordinator(s) listed at the below.

Ryan Olson
Reiko Mitsunaga, RN

Participate in the INFORM Trial

Trial Criteria

Inclusion Criteria

Subjects must meet all the following criteria to be eligible to enroll in the study.

  1. Have fibromyalgia (based upon the 2016 ACR criteria).
  2. Male or female between age 18-65
  3. Able to understand and comply with all study procedures and attend all study visits.
  4. Able to take oral medication and be willing to adhere to the metformin regimen (one pill once a day)

Exclusion Criteria

Subjects may not be eligible to enroll in the study if any of the following conditions apply.

  1. Have uncontrolled or unstable illness.
  2. Have a co-occurring progressive disease (such as cancer)
  3. Pregnant or planning to become pregnant in the next year.
  4. Have Type I or Type II diabetes mellitus requiring medical therapy
  5. Have autoimmune disease (like rheumatoid arthritis)
  6. Having: cardiovascular, liver, kidney or pulmonary
  7. Psychosis, history of inpatient psychiatric admission in the past year, active suicidal intent, history of self-injurious behaviors in the past year
  8. Substance abuse in the past year or any history of recreational IV drug use
  9. Have acute pain or neuropathic pain
  10. Concurrent use of weight controlling medications (e.g. Xenical)