The Lack of Evidence in “Evidence Based Treatment” for Alcoholism and Addiction

By Samuel Glazer, MD, Clinical Assistant Professor of Psychiatry, NYU Langone Health Many “for profit” treatment programs, both inpatient and outpatient, tout “Evidence Based Treatment” (EBT) as their approach to treat alcoholism, addition, and other substance use disorders. This label can be misleading, and though EBT sounds effective and backed by research (thus justifying the high cost of their programs), many “evidence based treatments” are actually associated with very poor outcomes. As a skeptical addiction psychiatrist in Manhattan, I have observed and communicated to many of my patients and colleagues that though labeled “evidence based,” and considered the standard of care for addiction, many evidence based treatments have either very little or no evidence or extremely biased research showing efficacy. I am grateful for the many conversations with my patients and colleagues about this concept that have provoked this blog post.

The Common Misconception of Evidence Based Treatment for Addiction

The concept of Evidence Based Treatment (EBT) in addiction treatment actually derives from the movement in health care towards Evidence Based Practices. In fact, when physicians use Evidence Based Practices in delivering healthcare, it tends to be a very good thing. In the Evidence Based Practice of medicine, decisions are based on real data (not gut reactions), minimizing cost and unnecessary morbidity and leading generally to better outcomes. But, like many things you hear about in the addiction treatment world, Evidence Based Treatment is not what it seems. The reality is that many treatment modalities for substance use disorders, though considered “evidence based,” often have very weak evidence behind them, in some cases none, and often are misused and/or administered by clinicians who do not have the training, experience or education to appropriately suggest them, let alone administer them. If one looks closely at the research, no medication or type of psychotherapy, even including Cognitive Behavioral Therapy, stands out as truly being effective or close to a cure for most addictions.

Types of Treatment for Substance Use Disorders

Treatment for substance use disorders falls into two categories:

1. Psychosocial: Includes individual and group psychotherapy (the most studied being Cognitive Behavioral Therapy).
2. Medication-Assisted Treatment: Includes medications that help with everything from detoxification, symptom relief, treatment of craving, and enhancing abstinence.

A few of these treatments really do work if used appropriately by the right people on the right patients in the right circumstances. But most do not show any statistically significant difference from placebo, and at best are comparable to AA, which is free and accessible to just about anyone anywhere in the world. Naltrexone is a wonderful example of an evidence-based treatment that is clearly effective for the treatment of Opioid Use Disorder. Naltrexone is an opiate blocker, meaning it binds to the opiate receptors in your brain so that if you take an opiate (prescription painkillers, Vicodin, Percocet, Oxycontin and heroin to name a few), you are not affected by it. Given monthly as an injection in the form of an extended release injectable suspension (Vivitrol) in combination with psychosocial treatments, it is clearly proven useful as an effective treatment in preventing relapse and enhancing abstinence from opiates in people in treatment for Opiate Use Disorders.1 But Naltrexone is also a wonderful example of how a minimally helpful treatment actually has been falsely promoted, poorly studied, and wrongly executed as an evidence based treatment for Alcohol Use Disorders.

Naltrexone, an “Evidence Based Treatment” for Alcoholism

Naltrexone is currently considered an “evidence based” drug treatment for alcohol use disorders and alcoholism. It is often referred to as the first line drug treatment for alcoholism by many journals and clinicians. There are studies and methods published in many journals and referred to in media as “evidence based treatments” for alcohol use disorders. Naltrexone is prescribed by many doctors to help people “control” or cut down on their drinking. Alcoholics are given the injection form when they are at rehab and outpatient programs to “help with long term craving” before they are discharged. There is even an entire program that has received a great deal of publicity called the Sinclair Method, which claims a 78% success rate in helping people control drinking with the use of naltrexone. Unfortunately, a recent systematic review of the literature found that Naltrexone (or any other drug for that matter including nalmefene, acamprosate, baclofen and topirimate) show very little efficacy in controlling drinking and what little efficacy they show come from studies with a high risk of bias.2

The History of the FDA’s Approval of Naltrexone

In order to understand how this misinformation on naltrexone for alcohol use disorders was established, one needs to look into the history of how it became FDA approved as a treatment for alcoholism. In the 1990’s, some studies showed that naltrexone could actually help a group of people in general cut down on their drinking. The FDA, desperate for some type of medication to help for alcoholism, and lobbied by big Pharma, approved naltrexone (brand name: Revia) as a pill indicated for alcoholism. If one reviews these studies, it is clear that the studies were not robust and were highly biased and conflicting. In fact, many of these studies actually showed naltrexone has no effect, at all, on alcohol use. Looking more closely at the data, most studies show it has no effect on rates of alcoholism, almost all show it has zero effect on craving, and a few show that a few people out of the group may drink a bit less over the period of time that they are taking it.

The Truth About Naltrexone as an Evidence Based Treatment

In summary, naltrexone is a first line EBT in alcohol use disorders. Naltrexone is prescribed to control drinking, help with craving, and even extinguish the desire to drink. Perform a web search and you will find many treatment programs boasting about their results with naltrexone. But, in reality, though there may be very scant evidence that it may cut down on the amount of drinking some people do, naltrexone cannot help people control drinking, demonstrates no effect on craving, and has zero effect on rates of people with alcohol use disorders in general.

Cognitive Behavioral Therapy as an Evidence Based Treatment

Some of you may be thinking, we all know Pharma influences medicine, what about behavioral treatments? Most programs (including our own) tout CBT or Cognitive Behavioral Therapy as part of their program. CBT is an EBT that is often contrasted to spiritual or self-help treatment. CBT is a therapy that was designed by psychologists to be easily studied, and there are many studies of the effects of CBT in substance abuse treatment. It is believed to be the gold standard of therapies for addiction but, in line with all psychosocial interventions for substance use disorders, abstinence rates are low and unstable overall. Although difficult to study, more and more evidence suggests that self-help and many other forms of treatment can be a first line treatment that is as effective as CBT. In fact, of all types of treatment, Contingency Management seems to stand out as being the most effective across the spectrum of substance use disorders. While CBT seems to work best for cannabis use disorder3, abstinence rates are still low.

Addiction Treatment is Not a One-Size-Fits-All Approach

As time goes on, and I add more entries to this blog, I hope to explore in more detail the limitations as well as efficacy of other treatments. But, suffice to say, there is no one size fits all. Though there are many types of both pharmacological and therapy-based treatments, most are limited in efficacy, often falsely advertised, or just misunderstood. A major qualification that I do want to make clear, is that though there are some charlatans in the addiction treatment world, and some who are too arrogant to understand their limitations (I know of one therapist who claims he has a 100% success rate in treating addictions!), I do believe most clinicians are in it for the right reasons and are looking for any thread of evidence that can help them help their patients. Though there is only modest evidence behind even the most effective of treatments, we as Manhattan addiction therapists use what we can to help people. The point of this blog is to shed some light on a highly misunderstood and stigmatized brain disease and the confusing information conveyed about its treatment mostly by for-profit programs preying on desperate and vulnerable people suffering with substance abuse disorders.

Our Manhattan Addiction Psychiatrist, Dr. Glazer, Provides Individualized Treatment

I was recently asked by a new patient who was consulting with me for his alcohol abuse what I could do for him to help him stop drinking. I thought about his for a minute and said (drawing on 20 years of experience treating substance use disorders and teaching at NYU Langone Health), “Not much.” I now understand that my most important role as a physician and therapist for alcoholism and addiction in Manhattan is to help provide a safe space, a trusting, mutually respectful relationship where I can help guide a person through their own recovery process. Every person I see in my consultation room is unique. Nobody is an “addiction” for which “an evidence based treatment” will cure them. Rather I join with my patient and collaborate to find what motivates and what will be most effective for them. For some, CBT is a great fit, for others, medication helps too, insight oriented or supportive therapy are best suited for some people, and others of course, are better off with twelve step programs. For most people, it is a combination of these different modalities as a part of a commitment to growth and life change. Everyone has their own path. As one of my former patients likes to say, “I had to pay hundreds of dollars an hour to go talk to a fancy Upper East Side psychiatrist so that over time, he could help me find the help I really needed for my addiction in AA.” (The last I heard from him he was sober many years and was recently engaged to be married).

Thanks for reading, and a special thanks to Charlie Silberstein, MD who is a wonderful friend, mentor, and writer, and whose own writing inspired me to start blogging.

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Sources:

1. A Randomized Trial Comparing Extended-Release Injectable Suspension and Oral Naltrexone, Both Combined With Behavioral Therapy, for the Treatment of Opioid Use Disorder. Sullivan MA, Bisaga A, Pavlicova M, Carpenter KM, Choi CJ, Mishlen K, Levin FR, Mariani JJ, Nunes EV. Am J Psychiatry. 2019 Feb 1;176(2):129-137. doi: 10.1176/appi.ajp.2018.17070732. Epub 2018 Oct 19.
2. Pharmacologically Controlled drinking in the treatment of alcohol dependence or alcohol use disorders, a systemic review with direct and network meta- analysis on nelmefene, naltrexone, acamprosate, baclofen and topiramate. bY Palpaccuer Et Al. Addiction, Feb2018 113(2) 220-237.
3. Psychosocial interventions for cannabis use disorder, Gates PJ1, Sabioni P, Copeland J, Le Foll B, Gowing L. Cochrane Database Syst Rev. 2016 May 5;(5):CD005336. doi: 10.1002/14651858.CD005336.pub4