Hormone Function in Men Treated for Pain With Opioids or Placebo
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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 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.