Melanie Cole (Host):  Welcome to Back to Health, your source for the latest in health, wellness and medical care, keeping you informed so you can make informed healthcare choices for yourself and your whole family. Back to Health features conversations about trending health topics and medical breakthroughs from our team of world-renowned physicians at Weill Cornell Medicine. I’m Melanie Cole and today we’re discussing low dose Naltrexone for chronic pain. Joining me is Dr. Neel Mehta. He’s the Medical Director for Pain Management and Co-Director of Weill Cornell Medicine’s Center for Comprehensive Spine Care. Dr. Mehta, it’s a pleasure to have you with us today and before we get into some of the treatments for chronic pain; tell us some of the most common reasons people come to you with chronic pain.

Neel Mehta, MD (Guest):  Chronic pain is a widespread condition. And there are a number of things that can lead to chronic pain. By definition, it’s pain that last longer than it should. So, typically, we say about 90 days, but unfortunately, there are people out there that have suffered a lifetime of pain. Some of the most common conditions are things that you probably are familiar with. Arthritis, spinal conditions, various nerve conditions known as neuropathies, headaches, and then conditions that lead to pain due to a disease, one such as cancer.

Host:  Dr. Mehta, since pain is so subjective, how do you measure it?

Dr. Mehta:  That’s a great question. Subjective pain is interpreting what a patient is telling us. But beyond sort of saying something hurts, we try to qualify it. Is it something that’s dull? Is it sharp? Does it have an electrical sensation? Do you feel pins and needles? Do you feel that certain things bring it on? Certain things make it better like sitting down versus being more active? And more importantly, as we’ve studied pain, we like to know how does it impact day to day life? Are you able to do your activities of daily living such as eating, showering, shaving? Are you able to go to work and have a productive day at work especially if you are in a more labor intensive job? Are you able to sleep at night and get a restful amount of sleep without having to get up and be disrupted the whole time?

So, we call that an overarching functional ability. Are you able to function in your day to day life and the limitations on that. Then we also look at how does it affect you mentally. Has it led to anxiety, depression and other mental conditions that can be impacted when somebody suffers from debilitating pain every day.

So, over the years, we have developed validated questionnaires that have been studied in broad populations that we provide to patients when we see them both at the first visit and then on follow up visits to understand beyond a rating of just zero through ten for pain, on how impactful it is and how much progress we are making along their treatment course.

Host:  Dr. Mehta, as we’re talking about pain and the reasons that people come to you; tell us about this novel treatment, low-dose naltrexone as a novel anti-inflammatory treatment for chronic pain. What is it? How does it work?

Dr. Mehta:  Low-dose naltrexone has essentially been around for a number of years. But it’s use in chronic pain is a more recent phenomena. And by the name, you can tell that it’s a specific dose range of a particular drug naltrexone. So, what is naltrexone? Naltrexone is a drug that was discovered a number of years ago where it binds to the MU receptor in our body. And that receptor is involved in pain and pleasure modulation. So, naltrexone blocks this and prevents this transformation of that receptor to lead to mitigation of pain or leading to pleasurable activities.

So, its most common treatment was the treatment of addiction such as alcohol or gambling and using a dose as high as 50 milligrams, you can mitigate those addictive properties in a patient. But what was discovered through trial and error, was if you give doses far less than the 50 milligrams, you may be able to achieve pain relief. And what doses are those? They can be as low as 0.01 milligrams to 6 milligrams or 8 milligrams given orally or in a liquid or some formulation like that. So, hence the term was coined low-dose naltrexone or even potentially ultra-low-dose naltrexone for the treatment of pain.

And how does it work? Well, it temporarily binds the MU receptor blocking it for a short period of time and that leads to a trigger in our body that perhaps there’s not enough pleasurable endorphins being released so it causes the body to increase its own production of endorphins. And endorphins again, are our natural pain relievers. It’s what leads us to have a pleasurable response in our body when something is triggering that endorphin release.

So, here’s a novel product or novel compound that can use our body’s own natural abilities to heal and treat pain without the side effects of some of the opioid medications that we’ve all heard about and some of the trouble that opioid medications can cause and mitigate a lot of chronic pain that people suffer.

Host:  When you say chronic pain, what are we talking about? Are we talking about back pain, knee pain; there are so many different types of pain. Can this be used systemically for various types of pain in the body?

Dr. Mehta:  That’s a great question. And I should start out by saying that it has been used in a number of pain conditions. So, for example, some of the studies that have come out treat a condition called fibromyalgia. And fibromyalgia is a whole body wide sensitivity of nerve cells that trigger a pain response that’s not typical for the average patient. So, a somewhat greater or more exaggerated pain that’s felt from a typical injury. Or a sensitivity of muscles or other soft tissue related to pain.

So, fibromyalgia has been studied. Pain related to multiple sclerosis and other types of nerve conditions or neuropathies that people may be familiar with. It has been used in headache and then there are some early evidence to show that it may even help in arthritis. Now it’s important to talk about the studies that are being done and the limitations. So, this drug as I mentioned, has been around for a long period of time. And therefore, it is no longer a drug that has a patent. That means that generic medications are available and make it very affordable to obtain the medication. But because of that, the studies that would be used by the FDA that are sponsored by pharmaceutical companies cannot be done. Because there’s no viable commercial opportunity here to sell a drug for a high price.

So, it’s good for the patient because it’s very obtainable but there’s limitations on the scale and size of studies that can be done. So, people like myself, and colleagues all across the world have come together to do studies on this particular drug but it’s important to have the disclaimer that this is not an FDA approved indication, that this is used off label with the guidance of the medical community.

Host:  Well thank you for clearing that up. So, Dr. Mehta, is this used as a monotherapy for these types of pain such as fibromyalgia, because you mentioned endorphins which exercise can help to release as well but exercise could be a limiting factor for some of these people that suffer from this type of chronic pain. Are you using it in conjunction as an adjuvant therapy or how is it really working? Tell us a little bit about some of your outcomes as well.

Dr. Mehta:  That’s a great question. And yes, exercise is something that we know leads to endorphins. Similarly, this drug does the same process. But it takes time. So, I will prescribe a medication to patients, of low-dose naltrexone and I explain that we don’t know exactly what dose is going to be effective and that it’s going to take time for the body to adapt to this particular drug being present. So, we generally start them at 1.5 milligrams once a day to be taken on a relatively empty stomach, preferably at night when we believe the body is most likely to produce endorphins and we look for a response after a few weeks.

The dose will gradually increase over the course of a month going from 1.5 to 3 milligrams to 4.5 and then finally 6 milligrams. And that’s generally where my patients report pain relief greater than 50% or some sort of measure that improves their function whether it’s better sleep, better ability to exercise or return to work. I often will find that I’m prescribing this in patients that have already tried other things such as Advil, or ibuprofen or acetaminophen. They may have also tried gabapentin or Lyrica, or other types of nerve pain drugs often prescribed for these conditions.

So, generally, I’m not prescribing this as a first therapy for someone coming to meet me. Furthermore, as I mentioned, we don’t know what dose is going to be effective. So, this is our algorithm to start out. But I’ve also experienced patients that didn’t get relief from 1.5 to 6 milligrams and instead got relief at 0.1 milligrams for reasons that we don’t completely understand. But likely believe that there are different mechanisms of action depending on the dose. We’ve already seen that in a difference that 50 milligrams does versus 1.5 milligrams. So, how do you obtain this drug?

Well this drug has to be custom compounded which means that a specialty pharmacy or a chemist has to take the 50 milligram dose, grind it down, and then measure the amount needed for the dose that we create. And this can be done in two ways. It can be done through a capsule where they take an empty shell and fill the powder inside or it can be formulated as a new tablet that could be split in half. And I like the latter option because that allows me to more conveniently titrate or change the dose over the course of a month when people take tablets. And it’s very inexpensive as I mentioned. So, typically 60 pills costs about $30 and that’s the cash price. So, many people’s copays on branded drugs exceed $30 and here it is the whole drug itself is 30 bucks.

Host:  How interesting. What an informative segment. Wrap it up for us Dr. Mehta with what you would like listeners to know about this novel treatment for chronic pain and what questions you want them to ask you when they come to see you as a pain specialist at Weill Cornell Medicine.

Dr. Mehta:  Well thank you again for the opportunity. I believe that patients should understand that there are options beyond the typical anti-inflammatory, Lyrica, gabapentin and other antidepression drugs that are often prescribed for pain. Not that there are anything wrong with those products, but that there are additional opportunities especially with the exciting opportunity with low-dose naltrexone. I often tell my patients to read about it on the internet especially a group called the low-dose naltrexone research trust which is a group of clinicians that have come together to put together high quality articles and evidence to further educate the population about this.

In terms of what else to ask. It’s important to know what interactions may occur. And fortunately this drug has few interactions and also understand that there are limitations in our knowledge about this given the sort of early studies. But we have seen good results with low harm and therefore it’s important to ask your doctor about the opportunity to try this. To talk about Weill Cornell, the opportunity is provided to patients through a clinical visit whether that’s on Telemedicine or in person. And we are welcoming new patients to discuss this.

Host:  Thank you so much Dr. Mehta for coming on with us today and sharing your expertise. What a fascinating topic. And Weill Cornell Medicine will continue to offer video visits for consultations and discussion to minimize travel and you can be confident of the safety of in person appointments if needed.

That concludes today’s episode of Back to Health. We’d like to thank our listeners and invite our audience to download, subscribe, rate and review Back to Health on Apple Podcasts, Spotify, Google Play Music. For more health tips please visit www.weillcornell.org and search podcasts. And parents, don’t forget to check out Kids Health Cast. I’m Melanie Cole.