RECRUITING

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

Conditions

Opioid Use Pain Hypogonadism, Male Opioid Analgesics Testosterone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-01-10

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04798469

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Leila Chammas

CONTACT

617-278-0722

lchammas@bwh.harvard.edu

Principal Investigator

Shehzad Basaria, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Robert R Edwards, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-10

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2022-01-10

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

Pain
Opioid Analgesics
Testosterone

Additional Relevant MeSH Terms

Opioid Use
Pain
Hypogonadism, Male