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New treatment option for Opioid Use
Official title Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism
ClinicalTrials.gov ID: NCT04798469
What this study is testing
What is Testosterone Undecanoate 250 MG/ML?
Testosterone Undecanoate 250 MG/ML is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for opioid use.
Also referred to as Testosterone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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 likely can't join 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.
See the full eligibility 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.
- 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 people who are otherwise eligible and either do not qualify for...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.