Testosterone treatment for pain relief in men with opioid-induced low testosterone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of testosterone replacement therapy in improving pain perception, pain tolerance, sexual function, fatigue, and quality of life in men suffering from chronic spinal pain and opioid-induced hypogonadism. The study is designed as a single-center, randomized, double-blind, placebo-controlled trial, where participants will receive either testosterone undecanoate or a placebo for six months. Eligible participants are men aged 18 and older who have been using opioid analgesics for at least six months and have low testosterone levels. The outcomes will be compared between the testosterone and placebo groups to determine the therapy's efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Shehzad Basaria, MD — Brigham and Women's Hospital
• Study coordinator: Julia Crosby
• Email: jpcrosby@bwh.harvard.edu
• Phone: 617-525-6726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.