Effects of Osteoarthritis Pain, Morphine and Placebo on Neuro-Endocrine Function in Men

Date de début de l'étude : 13 juillet 2004

* INCLUSION CRITERIA: 1. Clinical evidence of chronic OA by history and examination in a major joint or the spine. 1. Pain level of 4/10 or greater on a scale of 0 to 10 2. Pain for a duration of 3 months or longer present at least 5 out of 7 days a week 3. Radiographic evidence of moderate to severe OA in the involved joint based on the Kellgren and Lawrence scoring scale. 2. Age between 30-65 at study entry 3. Men of all ethnicities 4. Ability to understand the study measures and mentally capable of giving consent to participate in the study (based on an 8th grade education level) 5. Willingness to refrain from taking opioids other than as dictated by the study design EXCLUSION CRITERIA : 1. Impaired pulmonary, renal, hepatic, cardiovascular or endocrine-metabolic function; major coexisting medical condition such as cancer, chronic obstructive pulmonary disease and severe hepatic and renal dysfunction 2. Primary or secondary endocrine disease such as diabetes or Cushing's syndrome 3. Prostatic disease requiring usage of urological medications 4. Presence of sexual dysfunction defined as lack of libido, impotence or erectile abnormalities. 5. Current symptoms of coronary artery disease 6. Presence of RA, or other types of inflammatory arthritis 7. Use of systemic corticosteroids in the two months before screening and study entry 8. Alcohol abuse up to a year prior to study enrollment 9. Usage of any recreational drugs 10. History of narcotic abuse at any time in the past 11. Major depression whether successfully or unsuccessfully treated or diagnosed at the time of study screening based on a score of greater than or equal to 20 on the Beck Depression Inventory 12. Hct less than 35; anemia or bleeding disorder 13. Allergy to morphine 14. Current or past history of fibromyalgia as described by Wolfe F et al., (1990) (a minimum of 12 out of 19 points of tenderness must be present to satisfy criteria for fibromyalgia) 15. Cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits 16. Age 29 years or less due to rarity of OA in this age group 17. Body mass index (BMI) greater than 30kg/m(2) and BMI less than 20kg/m(2) Usage of nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed at study entry and during the conduct of the study. Patients will be asked to refrain from using muscle relaxers, other opioids apart from the study drug (MS Contin), AED's (anti-epileptic drugs), TCAs (tricyclic antidepressants), SSRIs (selective serotonin reuptake inhibitors) and benzodiazepines for pain control during part II and III. Patients will also be asked to refrain from having local joint injections with steroids or other agents. Patients will be queried regarding their use of complementary and/or alternative medicine (CAM) treatments (e.g. acupuncture, chiropractic manipulations, herbs and botanicals, and mind-body interventions) at the start of the study and will be counseled against beginning CAM treatments during the study protocol. Starting any of these treatments during the study will be considered a study violation. The only exception will be for glucosamine and/or chondroitin.