Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Ki vehet részt

• Men, age 18 years and older
• Chronic non-cancer spinal pain
• Use of opioid analgesics for at least 6 months
• Serum total testosterone (measured by mass spectrometry) <348 ng/dL and/or free testosterone <70 pg/mL
• Ability and willingness to provide informed consent

Ki nem vehet részt

• Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis
• History of prostate cancer or breast cancer
• Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease)
• Uncontrolled congestive heart failure
• Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months
• Diagnosis of bipolar disorder or schizophrenia
• Serum creatinine >2.5 mg/dL
• Alanine aminotransferase (ALT) level 3 times above the upper limit of normal
• Use of testosterone within the past 6 months
• Baseline hematocrit >48%
• Prostate-specific antigen (PSA) level >4 ng/mL in Caucasians or >3 ng/mL in African-Americans
• Presence of prostate nodule or induration on digital rectal examination