Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Opioid Use, Pain, Hypogonadism, Male

In brief

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

Key facts

Study ID

NCT04798469

Run by

Brigham and Women's Hospital

People needed

150

Starts

2022-01-10

Expected to finish

2027-12-30

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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