Hormone Function in Men Treated for Pain With Opioids or Placebo

This is an interventional treatment trial for Chronic Pain focused on measuring Analgesia, Chronic Pain, Neuroendocrine Axis, Degenerative Diseases Read More

-INCLUSION CRITERIA:

1. Clinical evidence of chronic OA by history, examination and radiological examination

   • a. Pain level of 4/10 or greater on a scale of 0 to 10 over a 2 week screening period
   • b. Pain for a duration of 3 months or longer present at least 5 out of 7 days a week by history
   • c. Radiographic evidence of moderate to severe OA in at least one joint selected for study based on the Kellgren and Lawrence scoring scale (Appendix I:Table 2)
2. Age between 30-65 at study entry. This age range was chosen as osteoarthritis is rare in people younger than 30 and to minimize the effect of the neuroendocrine changes associated with aging on study outcome measures.
3. Men of all ethnicities
4. Ability to provide his own consent and to cooperate with study procedures
5. Willingness to refrain from drinking alcohol during the study because alcohol may exacerbate the sedative effects of morphine
6. Willingness to refrain from using muscle relaxers, antiepileptic medications and antidepressants within 6 weeks of starting study procedures
7. Willingness not to be on opioids other than prescribed by the study for the duration of the study and willingness to come off of opioids six weeks prior to starting study procedures

EXCLUSION CRITERIA:

1. Impaired pulmonary, renal, hepatic, cardiovascular or endocrine-metabolic function or major coexisting medical condition such as cancer, Cushing s disease, and diabetes which may make participation unsafe or interfere with hormone measurements
2. Prostatic disease or hypertrophy which would make subjects prone to urinary retention or require medication that would interfere with study hormone measurements
3. Sexual dysfunction including lack of libido, impotence or erectile abnormalities for safety reasons as these symptoms may be worsened by morphine
4. Rheumatoid arthritis other types of inflammatory arthritis
5. Use of systemic corticosteroids in the two months before study entry which might interfere with study hormone measurements
6. Present or past history of alcohol dependence which might predispose subjects to problems with opioid dependence based on 2 or more positive responses to the CAGE questionnaire (the latter group will be referred to psychiatry for further evaluation and excluded from study if found to fulfill psychiatric criteria for alcohol dependence or abuse)
7. Current usage of any recreational or unauthorized prescription drugs because this may indicate abuse potential based on positive urine drug test at study screening visit
8. History of opioid abuse at any time in the past based on patient report or a urine drug screen positive for opioids
9. Major depression based on a score of greater than or equal to 20 on the Beck Depression Inventory at screening, present history of major depression or treatment for major depression because these may effect endocrine function
10. Hct < 35; anemia or bleeding disorder because subjects will undergo serial blood sampling to assess hormone function
11. Allergy or inability to tolerate to morphine
12. Current or past fibromyalgia according to Wolfe criteria (1990)
13. Present or past history of sleep apnea because of increased risk of respiratory depression with morphine
14. Body mass index (BMI) > 30kg/m(2) and BMI < 20kg/m(2)
15. Local steroid injections during the study because weight has significant effects on hormone levels
16. Addition of or changes to complementary or alternative treatments during the study