Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism (PATH)

Mass General Brigham

Status and phase: Enrolling; Phase 2

Conditions: Opioid Use; Hypogonadism, Male; Pain

Treatments: Drug: Placebo; Drug: Testosterone Undecanoate 250 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT04798469

2021P000331

Details and patient eligibility

About

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).

Full description

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Testosterone

Experimental group

Description:

Intramuscular injections of testosterone undecanoate 750 mg.

Treatment:

Drug: Testosterone Undecanoate 250 MG/ML

Placebo

Placebo Comparator group

Description:

Intramuscular injections of placebo.

Treatment:

Drug: Placebo