Clinical Trials

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).