Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Phase 2RecruitingNCT04798469

Brigham and Women's Hospital150 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Opioid Use Pain Hypogonadism, Male

Interventions

Testosterone Undecanoate 250 MG/MLDRUG

Intramuscular administration at a dose of 750 mg at baseline, weeks 4, and week 14.

PlaceboDRUG

Intramuscular administration of placebo at baseline, weeks 4, and week 14.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire

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.