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| Sponsor: | National Institute of Nursing Research (NINR) |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00737737 |
Purpose
This study will examine hormone function in men with osteoarthritis pain and how it is affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus placebo.
Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain at least 5 days a week over the past 3 months may be eligible for this study. Candidates are screened with a physical examination, x-rays, laboratory and other tests, and questionnaires about pain, mood and medical health. They are given a pain diary to complete for 2 weeks.
Participants are admitted to the hospital for two 12 hour overnight stays, during each of which they provide a 24-hour urine collection and have a small blood sample drawn every 20 minutes for 12 hours (from 8:00 p.m. to 8:00 a.m.) through a catheter that remains in place in a vein. Blood pressure and pulse are monitored during this time. After the catheter is removed, subjects complete questionnaires about their pain, mood and activity.
For the several weeks between the two hospitalizations, subjects take either an opioid medication or placebo, or standard medication such as motrin and naprosyn, according to random assignment to one of the three groups. All participants will be allowed to take anti-inflammatory medications and acetaminophen during this time as needed, but no other pain medications or treatments. They are monitored two or three times a week by telephone and complete a pain diary.
After the second hospitalization, subjects are tapered off the study medication. After 2 to 4 weeks of stopping medication, they return for a final outpatient visit to review pain or other medical problems and to have blood drawn.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain Osteoarthritis |
Drug: MS Contin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study |
| Official Title: | Effects of Chronic Musculoskeletal Pain and Opioidergic Versus Placebo Interventions on Neuroendocrine Function in Men |
| Estimated Enrollment: | 18 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Use of opioid medicines for relief of chronic pain is increasing substantially but opioidergic medications and chronic pain have been both shown to perturb neuroendocrine function. The objectives of this protocol are:
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 naive 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 naive 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.
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Responsible Party: | National Institutes of Health ( Raymond A. Dionne Jr., D.D.S./National Institutes of Nursing Research ) |
| Study ID Numbers: | 080190, 08-NR-0190 |
| Study First Received: | August 16, 2008 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00737737 History of Changes |
| Health Authority: | United States: Federal Government |
|
Analgesia Chronic Pain Neuroendocrine Axis Degenerative Diseases Chronic Pain |
|
Morphine Osteoarthritis Joint Diseases Physiological Effects of Drugs Central Nervous System Depressants Narcotics Rheumatic Diseases Pharmacologic Actions |
Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Arthritis Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
