Androgen Replacement Therapy

Testosterone for Opioid Use Disorder

Phase 2
Led By Shehzad Basaria, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic non-cancer back pain.
Use of opioid analgesics for at least 6 months.
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upbaseline, 3 months, and 6 months
Awards & highlights

Study Summary

This trial is testing whether testosterone replacement can help improve pain perception, pain tolerance, sexual function, fatigue, and quality of life in men with chronic back pain being treated with opioids who have low testosterone due to their opioid use.

Eligible Conditions
  • Opioid Use Disorder
  • Pain
  • Testicular Hypogonadism

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have long-term back pain that is not related to cancer.
You have been taking opioid pain medication for 6 months or more.
You have long-term back pain that is not related to cancer.
You have been taking strong pain medications called opioids for at least 6 months.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in scores in the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire
Secondary outcome measures
Changes in default mode network connectivity
Changes in response to quantitative sensory testing of pain under a mechanical stimulus
Changes in response to quantitative sensory testing of pain under cold stimulus
+3 more
Other outcome measures
Changes in Patient's Global Impression of Change (PGIC) scores
Changes in catastrophizing assessed with the Pain Catastrophizing Scale (PCS) questionnaire
Changes in depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TestosteroneExperimental Treatment1 Intervention
Intramuscular injections of testosterone undecanoate 750 mg.
Group II: PlaceboPlacebo Group1 Intervention
Intramuscular injections of placebo.

Find a site

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,545 Previous Clinical Trials
11,380,054 Total Patients Enrolled
Shehzad Basaria, MDPrincipal Investigator
Brigham and Women's Hospital
3 Previous Clinical Trials
333 Total Patients Enrolled
Robert R Edwards, PhDPrincipal Investigator
Brigham and Women's Hospital
2 Previous Clinical Trials
396 Total Patients Enrolled

Media Library

Testosterone cypionate (Androgen Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04798469 — Phase 2
Opioid Use Disorder Research Study Groups: Testosterone, Placebo
Opioid Use Disorder Clinical Trial 2023: Testosterone cypionate Highlights & Side Effects. Trial Name: NCT04798469 — Phase 2
Testosterone cypionate (Androgen Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04798469 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for individuals to partake in this experiment?

" records indicate that this clinical trial is currently recruiting patients, with the initial posting occurring on January 10th 2022 and a recent update being made on September 16th 2022."

Answered by AI

What prior experiments have been done on Testosterone cypionate's effects?

"Currently, there are 29 ongoing clinical trials for Testosterone cypionate and 5 of these trials have been moved to Phase 3. While some of the studies may be located in Houston, Texas, a total of 124 medical sites offer this research opportunity globally."

Answered by AI

What potential risks are associated with Testosterone cypionate usage?

"Testosterone cypionate's safety has been partially established, thus receiving a rating of 2 on the scale. However, efficacy remains unconfirmed given this is only a Phase 2 study."

Answered by AI

What are the expected outcomes of this medical experiment?

"This 6-month clinical trial has a primary focus of assessing changes in scores for the Pain Interference Subscale of the Brief Pain Inventory (BPI) questionnaire. Furthermore, secondary outcomes include Quantitative sensory testing to measure deep pressure pain response with cuff pressure algometry, quantifying responses to pressure stimulation through digital pressure algometer readings, and gauging reactions to mechanical pain by repetitive stimuli ("windup") tests with punctate probes."

Answered by AI

How many participants is this research endeavor recruiting?

"Affirmative. Per the data available on, this investigation is actively soliciting participants since its inception in January 10th 2022 and most recent refreshment on September 16th of the same year. A total of 150 individuals are required to be recruited from a single research site."

Answered by AI

To what medical conditions is testosterone cypionate typically applied?

"Testosterone cypionate is widely prescribed to treat hypogonadotropic hypogonadism, however it can also be taken as a therapy for post-menopausal women and those that have undergone orchidectomy or orchitis."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
~33 spots leftby Apr 2024