Status:
COMPLETED
Hormone Function in Men Treated for Pain With Opioids or Placebo
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Chronic Pain
Osteoarthritis
Eligibility:
MALE
30-65 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 objective of th...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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)
- 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.
- Men of all ethnicities
- Ability to provide his own consent and to cooperate with study procedures
- Willingness to refrain from drinking alcohol during the study because alcohol may exacerbate the sedative effects of morphine
- Willingness to refrain from using muscle relaxers, antiepileptic medications and antidepressants within 6 weeks of starting study procedures
- 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:
- 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
- Prostatic disease or hypertrophy which would make subjects prone to urinary retention or require medication that would interfere with study hormone measurements
- Sexual dysfunction including lack of libido, impotence or erectile abnormalities for safety reasons as these symptoms may be worsened by morphine
- Rheumatoid arthritis other types of inflammatory arthritis
- Use of systemic corticosteroids in the two months before study entry which might interfere with study hormone measurements
- 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)
- 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
- History of opioid abuse at any time in the past based on patient report or a urine drug screen positive for opioids
- 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
- Hct \< 35; anemia or bleeding disorder because subjects will undergo serial blood sampling to assess hormone function
- Allergy or inability to tolerate to morphine
- Current or past fibromyalgia according to Wolfe criteria (1990)
- Present or past history of sleep apnea because of increased risk of respiratory depression with morphine
- Body mass index (BMI) \> 30kg/m(2) and BMI \< 20kg/m(2)
- Local steroid injections during the study because weight has significant effects on hormone levels
- Addition of or changes to complementary or alternative treatments during the study
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00737737
Start Date
August 1 2008
End Date
April 1 2014
Last Update
April 29 2015
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892