Effect of Opioid Use and Fibromyalgia on Steroid Metabolome and Adrenal Function

Overview

About this study

The purpose of this study is to determine the abnormalities in urine steroid profiling and association to the daily opioid dose in patients treated with opioids as compared to the existent cohort of healthy controls, and to identify the steroid signature associated with low quality of life, including physical and mental health.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Cross sectional study of prospectively enrolled 150 patients who will be enrolled from the pain clinic and endocrine clinic based on the following criteria:
    • Age 18 years and above;
    • Current opioid use of at least 20 MME per day, for at least 3 months;
    • Ability to provide informed consent;
    • Willingness to participate in study procedures;
    • Absence of known or suspected adrenal insufficiency of any other cause ( pituitary surgery, megace, etc.) or glucocorticoid exposure;
    • Pregnant women will be excluded on the basis that the steroid profile results could be skewed because of hormonal cause. Women of childbearing potential will be asked if they are pregnant and, if so, will then be excluded from participation.
  • Assessment – one-time assessment (cross-sectional study) to include the following:
    • Medical record review:
      • Type, dose and duration of opioid use, other medication use and steroid use;
      • Demographic information;
      • Comorbidities;
      • Type of pain/indications for opioid therapy.
    • Health interview:
      • Confirmation of duration and dose of opioids;
      • Review of medications and comorbidities;
      • Review of exogenous steroid use;
      • Smoking history;
      • AddiQOL survey;
      • SF36 survey.
  • Physical assessment:
    • 6 minute walk test.
  • Biomaterial collection and measurements:
    • Morning ACTH, cortisol and DHEAS measurements (clinical measurement);
    • 24 h urine collection for cortisol (clinical measurement) and steroid profiling assessment (research test).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Irina Bancos, M.D.

Open for enrollment

Contact information:

Melinda Thomas B.S.

Thomas.Melinda@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20457706

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