Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Description

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).

Conditions

Opioid Use, Pain, Hypogonadism, Male

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Study Overview

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Study Details

Study 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).

Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Condition
Opioid Use
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Shehzad Basaria, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Robert R Edwards, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2025-04-30