Hormone Function in Men Treated for Pain With Opioids or Placebo

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Pain, Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00737737

Run by

National Institute of Nursing Research (NINR)

People needed

8

Starts

2008-08-01

Expected to finish

2014-04-01

Last updated by the study team

2015-04-29

Who can join

Age: 30 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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