Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
{ "Testosterone for Opioid-Induced Low Testosterone and Pain", "This study is looking at whether testosterone replacement can help men who have chronic (long-lasting) spinal pain, are taking opioid pain medications, and have opioid-induced hypogonadism (low testosterone). You might be able to join if you are a man aged 18 or older with chronic non-cancer spinal pain, have been using opioid pain relievers for at least six months, and have low testosterone levels. Participants will receive either Testosterone Undecanoate or a placebo (an inactive substance) as an injection. The main goal is to see if testosterone improves your pain, sexual function, fatigue, and overall quality of life. The study plans to enroll 150 participants.", "design": "This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the active drug or a placebo, and neither you nor your doctor will know which you are receiving. It is a single-center study.", "commitments": "You would receive intramuscular injections at the start of the study, at week 4, and at week 14. Your pain levels will be assessed at the start of the study, at 3 months, and at 6 months.", "compensation": "Not stated in the trial record.", "follow_up": "Your pain levels will be assessed for up to 6 months after the start of treatment.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shehzad Basaria, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
- Robert R Edwards, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaireBaseline, 3 months, and 6 months
The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life.