Low-dose Naltrexone Clinical Trial | Emory School of Medicine

Welcome to Our Clinical Trial Site!

Low Dose Naltrexone for the Treatment of Chronic Neuropathic Pain in Patients with Human Immunodeficiency Virus (HIV): a Prospective, Pragmatic, Open Label Clinical Trial

ClinicalTrials.gov ID: NCT05537935

Study Background & FAQs
About Our Study
Who Are We?
Contact Us
Study Progress and Results

Study Background & FAQs

What is a clinical trial?

Per the National Institutes of Health:

“Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people. Often, a clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.”

What is the purpose of this clinical trial?

The purpose of this study is to investigate how well low dose naltrexone (LDN) works to treat neuropathic pain in patients living with HIV.

As medication options for patients living with HIV improve, these patients are living longer and alsoexperiencing more chronic conditions, including chronic
Current pain treatments often include opioids, which can have other negative consequences
We think LDN will provide an effective alternative to treat chronic, neuropathic pain in patients living with HIV. This study aims to gain scientific evidence about LDN as a neuropathic pain reliever.

What is Low-Dose Naltrexone (LDN)?

Naltrexone is an FDA-approved medication for addiction treatment. It’s an opioid antagonist and works by preventing the “high” feeling that can accompany use of opioids and alcohol.
Low dose naltrexone (LDN) is administered at 1-5 mg daily, whereas a standard naltrexone dose is 50 mg daily.
LDN has been shown to be effective for the treatment of chronic pain, including neuropathic pain.

Does LDN cause side effects?

Side effects of Low Dose Naltrexone are very rare.
People sometimes report having vivid dreams in the first week or two of treatment.
Very rare side effects include fatigue, anxiety, and dizziness.

Contact Us

About Our Research Study

Who can participate in this clinical trial?

Who is eligible?

Adults living with HIV between the ages of 18 and 65
Patients with neuropathic pain and an average pain score above 4 out of 10

Who is NOT eligible?

Patients currently taking opioids (except Tramadol, which is not disqualifying)
- Patients on opioids may opt to participate in the control group rather than the experimental group
Pregnant or nursing persons
Patients with severe liver disease
Patients on dialysis
Patients with active drug or alcohol use disorders (marijuana use is not disqualifying)

What does being a study participant involve?

Study participants will either be in our experimental group, or our control group for about 13 weeks
The experimental group participants will take daily LDN and participate in 4 in-person visits, while control group participants will not
All participants will complete weekly pain scores and participate in telephone visits
Participants will receive compensation (details under the experimental group and control group sections below)

What do I have to do if I participate in the experimental group?

You will take daily LDN throughout the study period. This will be provided to you by the study team at your in-person visits
You will attend 4 in-person visits at an Emory site in Atlanta, GA
These visits will take place during weeks 1, 4, 8, and 12 of study participation
The first and last in-person visits will involve a blood draw
In-person visits may last approximately 1 hour
You will participate in 10 remote “visits.” Each remote “visit” is a brief phone call, up to 15 minutes
Experimental group participants will be compensated $100

What do I have to do if I participate in the control group?

You will only do remote “visits” during the 13 weeks of the study; no in-person visits will take place
You will NOT be given LDN. You will not have your blood drawn
Control group participants will be compensated $25

Addional Information:

Who Are We?

Principal Investigator:

Dr. McKenzie-Brown (shown right) works as a pain management physician at Emory. She works with many patients dealing with neuropathic pain, while some of her co-investigators work in infectious disease and with many patients living with HIV. After years of prescribing LDN as a treatment for neuropathic pain, Dr. McKenzie-Brown decided to start a clinical trial investigating use of LDN to treat chronic neuropathic pain in patients living with HIV, with the support of her co-investigators.

Co-Investigators:

• Dr. Vinita Singh, MD

• Dr. Kimberly Workowski, MD

• Dr. Igho Ofotokun, MD

• Dr. Brian Bobzien, MD

Clinical Research Nurses:

• Renee Atkins, BSN, RN

• Katherine Egan, BSN, RN

Study Progress & Results

We have opened our study with a Community Engagement Element, administering surveys to learn about the community’s experience of living with HIV and chronic pain.
Clinical trial recruitment and enrollment is active as of Spring 2023.
We are committed to transparency and know some of our participants might want to read about clinical trial results once publication occurs. That may not happen for a while as research and publication takes a long time, but once we have published results, you can find them here!