Testosterone treatment for pain relief in men with opioid-induced low testosterone
Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism
This study is testing if testosterone treatment can help men with chronic spinal pain and low testosterone from using opioids feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04798469 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 years and older with chronic non-cancer spinal pain who have been on opioid analgesics for at least six months and have low testosterone levels.
Not a fit: Patients with a history of prostate cancer, organic hypogonadism, or other specified medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and overall quality of life for men with opioid-induced hypogonadism.
How similar studies have performed: Other studies have explored testosterone therapy in similar contexts, but this specific approach in opioid-induced hypogonadism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.