Protocol Number: 08-M-0190
(1) To determine whether long term opioid usage in men with chronic pain due to osteoarthritis results in abnormalities of ACTH, cortisol, LH and testosterone secretion. (2) To evaluate whether placebo analgesia results in a similar hormonal response as an opioid analgesic. (3) To evaluate the effects of chronic pain per se on ACTH, cortisol, LH and testosterone secretion. To address these questions, a protocol with the same name was initiated at NCCAM in 2004. In the first phase of this study 12 opioid na ve men with chronic OA pain were compared to12 healthy men by means of 12 hour overnight frequent blood sampling for measurement of baseline ACTH, cortisol, LH and testosterone. The results of phase 1 suggest that chronic osteoarthritis pain does not affect ACTH, cortisol, LH and testosterone secretion in middle aged men as compared to matched controls. In phase 2, 36 opioid na ve patients with chronic OA pain, all of whom will have undergone overnight baseline hormone sampling are randomized to one of three treatment groups: MS Contin (15-90 mg), placebo and standard treatment. Standard treatment includes nonsteroidal anti-inflammatory medications and Tylenol only. Doses of placebo and MS Contin are escalated over 4-8 weeks in a similar fashion followed by a two-week maintenance period. At that point patients return for repeat 12 hour frequent sampling of the same hormones as at baseline. They are then tapered off of study medications over a period of 2-4 weeks as outpatients. Subjects then return to clinic for a final visit and, AM blood will be obtained for ACTH, cortisol, LH, and testosterone. Twenty four subjects have already been recruited in this phase of the study (including the 12 opioid na ve men whose baseline endocrine functions were measured in phase 1. The primary endpoints of this study are measures of ACTH, cortisol, LH, and testosterone secretion, whereas secondary endpoints are neurobehavioral indices such as pain symptomatology on a 0-10 (Likert) scale, the Oswestry Disability Index, Multidimensional Pain Inventory, and the Beck Depression Inventory. It is anticipated that the results of the second phase of this study will provide novel information regarding the effects of treatment with opioids and placebo effect on selected neuroendocrine functions in men.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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