Protocol Number: 08-M-0190

Title:

Effects of Chronic Musculoskeletal Pain and Opioidergic versus Placebo Interventions on Neuroendocrine Function in Men

Number:

08-M-0190

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Children

Female

Eligibility Criteria:

INCLUSION CRITERIA:

-Clinical evidence of chronic OA by history, examination and radiological examination

-Pain level of 4/10 or greater on a scale of 0 to 10 over a 2-week screening period

-Pain for a duration of 3 months or longer present at least 5 out of 7 days a week by history

-Radiographic evidence of moderate to severe OA in at least one joint selected for study, based on the Kellgren and Lawrence scoring scale

-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 more than one glass of wine or the equivalent amount of alcohol during the study because alcohol may exacerbate the sedative effects of morphine

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 or 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

-Usage of any recreational drugs because this may indicate abuse potential; positive urine drug test at study screening visit

-History of opioid abuse at any time in the past

-Major depression based on a score of greater than or equal to 20 on the Beck Depression Inventory at screening because this may affect endocrine function

-Hct less than 35; anemia or bleeding disorder because subjects will undergo serial blood sampling to assess hormone function

-Allergy 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) greater than 30kg/m(2) and BMI less than 20kg/m(2) because weight has significant effects on hormone levels

-Local steroid injections during the study

Special Instructions:

Currently Not Provided

Keywords:

Analgesia

Chronic Pain

Neuroendocrine Axis

Degenerative Diseases

Recruitment Keyword(s):

Chronic Pain

Condition(s):

Chronic Pain

Osteoarthritis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: MS Contin

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Joranson DE, Ryan KM, Gilson AM, Dahl JL. Trends in medical use and abuse of opioid analgesics. JAMA. 2000 Apr 5;28 (13):1710-4.

Bolelli G, Lafisca S, Flamigni C, Lodi S, Franceschetti F, Filicori M, Mosca R. Heroin addiction: relationship between the plasma levels of testosterone, dihydrotestosterone, androstenedione, LH, FSH, and the plasma concentration of heroin. Toxicology. 1979 Dec;15(1):19-29.

Celani MF, Carani C, Montanini V, Baraghini GF, Zini D, Simoni M, Ferretti C, Marrama P. Further studies on the effects of heroin addiction on the hypothalamic-pituitary-gonadal function in man. Pharmacol Res Commun. 1984 Dec;16(12):1193-203.

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