Is Naltrexone An Ineffective Treatment for Alcoholism?

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Is Naltrexone An Ineffective Treatment for Alcoholism?

By Dr. Richard Juman 07/16/15

Or are we just using it the wrong way?

Image: 
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JAMA Psychiatry recently published a well-designed study whose authors included Charles O'Brien, MD, chair of the Substance-Related Disorders Work Group for the DSM-5. The results call into question the overall efficacy of naltrexone for alcohol use disorder. But could the drug be significantly more effective if it were simply prescribed differently? Psychiatrist Stephen Cox argues that The Sinclair Method, in which naltrexone is only taken one hour prior to consuming alcohol, instead of the once-every-morning technique that is most commonly used, is significantly more effective than the traditional regimen. Claudia Christian, who readers may remember from her portrayal of "Lt. Commander Susan Ivanova" on Babylon 5, credits the technique with saving her life. They both argue for a wider adoption of the protocol in the United States.

Richard Juman: There are big differences between The Sinclair Method and the way that naltrexone is generally prescribed in the United States. Can you explain the differences to our readers? 

Dr. Stephen Cox: Unfortunately, although The Sinclair Method is tremendously more effective and much less expensive than the traditional technique, it is still virtually unknown in the United States. Used the proper way, the treatment is an astoundingly effective approach to treating alcohol use disorder, with success rates of around 78%. 

Since I am 65, I remember the history of naltrexone because I lived through the introduction of naltrexone decades ago. This is what happened, to the best of my recollection, and in my opinion—all of my comments represent my opinions, by the way.

Naltrexone​,​ under the brand name Revia​, was approved for use in AUD (​alcohol use disorder aka ​alcoholism) decades ago. The package insert said to use it in sober alcoholics. The package insert also said to stop the medicine if the alcoholic started to drink alcohol, detox them, put them back on Revia, then discharge them from ​the hospital while on Revia, admonishing them to stop Revia if they start to drink alcohol.

I recall that the medicine Revia (naltrexone) was generally not useful with my patients. However, I did have one curious experience at the time. One of my patients was an alcoholic, had two strikes at work, and he had gone through rehab both times—to no avail. I prescribed him Revia, a new medicine at the time,​ as he only had one more chance​: If he failed, he would be fired. He went to his girlfriend's apartment and watched a movie one Saturday afternoon. Going to her refrigerator for a beverage, he discovered a six-pack of cold beer: "It looked so good. I opened up one and started drinking. But I left half of it there on her kitchen counter when I left," he said.

I mentioned to him that I guessed that meant that the Revia failed to be of benefit since he crossed over into drinking. He took exception with that and said, "No, doc! I left half of that one beer. Doc, I don't drink a half beer and quit. I drink all the beers when I start." 

The drug, when used according to the FDA-approved package insert, fell on its face and rather rapidly fell into disuse due to a deserved bad ​reputation​.

Dr. Sinclair's research shows that extinction of alcohol abuse occurs when one drinks alcohol with naltrexone in the body at the time of drinking. If you use naltrexone in the absence of alcohol​,​ the drug serves no purpose. Dr. Sinclair told me that the only way the drug company got Revia on the market through the FDA was from the tiny improvement that was coming from alcoholics who ​​disobeyed their doctors’ orders and kept taking the drug through their drinking bout. They got better. The ones who followed doctors’ orders did not get better. 

Finland and other European nations ​use the naltrexone properly with drinking. Why Europe and not the US? One reason is that the discovery of how to use it properly occurred in Finland. Research in Finland is highly respected in Europe. Americans do not know how reliable Finnish research is. So, the research had difficulty getting across the Atlantic. 

Claudia Christian: Doctors all over the world predominantly prescribe naltrexone on a daily basis—in the morning and with abstinence. TSM states that one must take the medication one hour prior to the first drink of the day. It is my opinion that taking it in the morning on a daily basis will block “good” endorphins and not block the addictive compulsion of the behavior you wish to unlearn. It makes no sense to me to have naltrexone coursing through your veins 24 hours a day. Since naltrexone is an opiate blocker (or antagonist) this means that if taken daily—in the morning as prescribed most often—you would be blocking “good” endorphin behavior and not specifically targeting the positive reinforcement of drinking, which is what one wants to target when one is suffering from alcohol use disorder.  

The goal is to eliminate the reinforcement of drinking by taking it one hour prior to the first drink of the day. This method makes more sense and has been proven to be far more effective than when taken daily and remaining abstinent. One must introduce the behavior one wishes to cease to the opiate antagonist in order to achieve pharmacological extinction.

Are there studies that highlight the difference in treatment outcomes between the two approaches?

Dr. Cox: Yes, there are numerous studies. They are all listed in Roy Eskapa's book, The Cure for Alcoholism. Anyone with trouble with alcohol ​should purchase Roy Eskapa's book.

CC: There are over 120 peer-reviewed clinical trials using naltrexone. The one that is the most often used for TSM is this one.

Given the research findings, why do you believe that The Sinclair Method has not been widely adapted in the US?

Dr. Cox: Several reasons. These are my opinions:

Its Achilles' heel is that it sounds too good to be true. With alcoholism's dismal response to treatment, even​ with the best rehab approaches, the 78% success rate of naltrexone, used properly, sounds, well, preposterous. I, too, ​thought ​this treatment idea was doomed to fail when Sinclair first told me of it a few years ago while visiting my home to discuss an anxiety patient I had that interested him. But I'll try anything once! That patient responded dramatically, as did the next one, and so forth. I was getting ​about ​three cures out of ​every four patients! Remarkable. But if Sinclair himself had not told me of it, I'd not have tried it.

AA is loathe to accept naltrexone for alcoholism. It isn't anything personal or scientific. AA just believes you can't cure an addiction with a medicine. They are well-intentioned, for certain. We still need them for the 22% of alcoholics who don't respond to The Sinclair Method. But they are wrong about this. But it is OK. They are not doctors or scientists. And AA is a very powerful influence and their opinion is widely accepted.

In my opinion, “Big Medicine” and the addiction treatment industry has been slow to react to TSM because it could be disruptive to the current model of treatment, and to the people and the entities that have been providing treatment the same way they have done for many decades. Most people in addiction treatment still haven’t heard about TSM, and certainly nobody seems to have figured out a legitimate way to make much money from using it. As one physician said at a rehab center where Dr. Sinclair gave a talk on naltrexone extinction of alcoholic behavior (Dr. Sinclair's words to me), "I just have one question: How am I going to make a living when this gets out?"

No patent. Well, sort of no patent. The 30-day injectable form of naltrexone still has a patent, I think. But in my opinion it is so expensive that it is uncommonly used, as people can't afford it out-of-pocket, I think it is $800-1000 a pop. So far as the generic pills go, there is no giant pharmaceutical company bombarding us with TV commercials of pretty actor people talking about, "Ask your doctor if naltrexone is right for you."

Few esteemed well-recognized proponents. I mean scientists and doctors, not celebrities. We lost the great Sinclair just weeks ago. We have Raymond Anton, MD, who is internationally recognized. Now that Dr. Sinclair has passed on, there is just Roy Eskapa, PhD, and Dr. Anton. We need key persons who are leaders in Emergency Medicine, Family Practice, Internal Medicine and so on to become proponents of this method and for those leaders to teach the new generations of health-care providers how to treat alcohol use disorder properly with naltrexone.

I gave a little lunchtime lecture to a group of family practice residents at the University of Kentucky College of Medicine the other day. Six of the dozen came up to me afterwards and were so excited about this new treatment that I told them they should be doing. They said it was the best lecture they ever had in training. I don't think their admiration for me was at the root of their estimation. I think they were just so excited to learn that there is something effective to throw at this terrible problem. They were excited to try it.

Numerous negative studies on using naltrexone in treatment of alcoholism. Studies where naltrexone fails generally appear to me to be studies where they used it the wrong way, that is, the traditional way. The studies that show naltrexone works used naltrexone in the midst of alcohol use as discovered by Dr. Sinclair and Dr. Anton to be so successful.

Finally, it is so time-consuming to talk people into giving it a try. It is as easy to treat alcoholism with naltrexone as it is to treat high blood pressure. But in treating alcoholics you have to persuade people and their families and that takes time. Lots of time. They have never heard of this. You have to gain their confidence to get compliance necessary for the treatment to work. Someday, that will no longer be the case. A treatment that works way more often than the old way and is way cheaper than the old way is going to inevitably have its "Prozac moment," when primary care physicians suddenly catch on that this naltrexone extinction therapy should be tried and it should be tried first, not last; and, should be prescribed by primary care. This is what happened when Prozac came out. It was a much safer medicine to prescribe to depressed persons who are the very patients most likely to overdose. Prozac was so safe in overdoses compared to the tricyclic antidepressants that family physicians felt comfortable prescribing it.

On the other hand, we (the naltrexone fans) do have recognition by the federal government, which devoted a whole chapter ​ on naltrexone in their TIPS manual, Pharmacotherapies in the Treatment of Alcoholism. We also have good outcomes in Dr. Anton's research; Dr. Anton has done the largest study on alcoholism in history. And we are lucky to have the actress Claudia Christian, who has a deep fervent passion for saving lives and devotes a lot of time to educating the world about this breakthrough. The article on AUD in The Atlantic in April 2015 also brought a lot of attention to this matter.

I did want to point out that The Sinclair Method is not just the pharmacologic extinction of over-drinking behavior. That's half of the Method. The other half is this: When the person improves to where there are days when they do not drink at all (and consequently they do not take the naltrexone), the person should engage fully in positive behaviors: exercise, eat vegetables, have sex—do things that improve your life and enhance your enjoyment of healthy living. The adjustment of one's endorphin receptors to this absence of naltrexone will cause an enhanced experience to these desired behaviors on those days—“Wow! These vegetables are fantastic!" Clients will learn to like vegetables and to incorporate them more and more into their life. So, while alcohol use is diminishing, healthy habits are increasing, without even trying. Nice!

CC: I believe that there are a variety of issues. The first is lack of education about The Sinclair Method. Most doctors simply do not know about pharmacological extinction, nor do patients. I personally was in a rehab facility and a medical detox while struggling with my alcohol issues. Not one person in either facility mentioned anything to me about naltrexone, or even discussed the idea that alcohol use disorder is a learned behavior and not a moral failure or a “personality disorder” as traditionally thought.

Secondly, it does sound like a “too good to be true” scenario, and it’s terribly counterintuitive to what we now view as “normal traditional treatment" for AUD. How do you tell someone suffering from AUD to drink? If you do not understand pharmacological extinction, and if you do not believe that one can unlearn a behavior, then it’s going to be difficult for you to grasp TSM. I also believe that there are a lot of financial concerns and “ego” factors involved any time there is a paradigm shift that threatens an existing status quo and a stable business model. But I am optimistic that even though people don’t believe in something or accept it right off the bat, eventually science and fact rule the day, and we have that on our side plus a remarkable success rate to boot! 

Stephen Cox, MD, is a physician whose professional life is multi-focused. He has a private practice in psychiatry, is the inventor of medical devices and Assistant Clinical Professor of Psychiatry at UK College of Medicine. He is also the founder of the National Anxiety Foundation.

Claudia Christian is an award-winning performer who has been acting in both television and film since she was 18, with more than 120 credits in her career. She is the author of the memoir Babylon Confidential in which she chronicles her decade-long battle with alcoholism. Claudia is an advocate for The Sinclair Method, the medical treatment for AUD that saved her life, and in 2013 launched The C Three Foundation to raise awareness and educate. In 2014, she made a documentary which is based on her journey on The Sinclair Method and follows people who have received the treatment.

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