Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 12, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how testosterone replacement therapy may help men who are experiencing chronic spinal pain due to long-term opioid use, which can lower testosterone levels (a condition known as opioid-induced hypogonadism). The researchers want to see if giving testosterone can improve not just pain, but also aspects like sexual function, energy levels, and overall quality of life compared to a placebo (a treatment that has no active ingredients).

Men who are at least 18 years old and have been taking opioids for at least six months may be eligible to participate, as long as they have low testosterone levels and do not have a history of certain medical conditions, like prostate cancer or severe heart issues. If you join the trial, you can expect to receive either testosterone or a placebo and undergo assessments to track changes in your pain and overall well-being. It’s an opportunity to help researchers learn more about potential treatments for pain management in men affected by opioid use.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • History of prostate cancer or breast cancer.
• • Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).
• • 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.
• • Uncontrolled congestive heart failure.
• • Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.
• • Serum creatinine \>2.5 mg/dL.
• • Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
• • Diagnosis of bipolar disorder or schizophrenia.
• • 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.