Why did doctors forget about naltrexone, and is it safe to start the Sinclair Method now?
Naltrexone is a generic prescription tablet that blocks opioid receptors. The Food and Drug Administration (FDA) approved it for alcohol dependence in 1994. Yet, in the medical treatment of alcoholism, it is rarely prescribed.
Somehow, over the years, doctors stopped talking about naltrexone and stopped prescribing it. Then, a scientist and an actress got people talking again.
The Sinclair Method, or TSM, was created by the late Dr. John David Sinclair and publicized by actress, Claudia Christian. With TSM, a person takes naltrexone one hour before drinking, and the aim is for the drinking to come down over time. I am an osteopathic physician, and I prescribe naltrexone for alcohol use disorder. This article is the companion to an interview that I recorded with Ms. Christian for The Rehab Podcast.
So, does it work? Is it safe? And, why has your own doctor never mentioned it?
Why don’t doctors prescribe naltrexone?
While it is important to have some faith in our healthcare system, we all have a sense that it is heavily influenced by profit-motivated pharmaceutical companies. When the patent on a drug expires, the drug suddenly seems old, less effective, and more likely to cause side effects.
Naltrexone has suffered this fall into obscurity. Yet, the fact is that some older medications are still good, and they have decades of use behind them. No sales representative visits the office with glossy brochures for a generic tablet. Nobody buys lunch for the staff.
As an older medication falls out of favor, newer medical school graduates do not see it being used, and they do not learn about it. We cannot blame a busy family doctor for staying with what they were taught. Still, the patient is the one who goes without.
How does the Sinclair Method work?
How can an opioid blocker help with drinking? The way that naltrexone works in alcoholism is not fully understood, although the body’s own opioid system appears to be involved. One theory is that drinking releases endorphins, the brain’s natural opioids, and that this reward teaches the brain to want the next drink.
With TSM, you take the tablet one hour before the first drink. The alcohol still arrives, but much of the reward does not. Dr. Sinclair called the result pharmacological extinction, meaning that a learned behavior fades when it is no longer rewarded.
An analogy that might help is a vending machine that takes your money and gives you nothing. The first time, you press the button again, and maybe you give the machine a shake. After enough tries, you stop walking down the hall to that machine at all.
While this is not a perfect analogy, it shows why the order matters. A tablet taken after the drink lets the machine pay out again. The key is the pill before the drink, every time.
It took an actress to bring a forgotten medication back.
Larry King discussed the Sinclair Method with Claudia Christian on a special program about rethinking alcoholism. Then, in 2014, came One Little Pill, a documentary that she narrated and helped to produce.
The film features Dr. Sinclair, and Ms. Christian gives her own account of heavy drinking and of the method that finally worked. She also founded the C Three Foundation to teach doctors and patients about TSM.
Interestingly, she starred in the science fiction series, Babylon 5, in which one of the main characters was named Sinclair, although there is no connection. You can download the podcast and hear her tell the story herself.
Why do films about addiction almost never show treatment that works?
One Little Pill is unusual. Films about addiction dwell on degradation, and on the familiar story of the fall, the rehab, and the relapse.
Ms. Christian had a role in the 1988 film, Clean and Sober, in which Michael Keaton plays a man who hides out in rehab. Many years later, rehab did not keep her from drinking, and she went on to make one of the few films that show an effective medical treatment.
Her documentary also shows how little interest the rehab industry has taken in that treatment. A generic tablet that a person takes at home does not fill beds.
I believe that we need more films like hers, about medication-assisted treatment (MAT) and harm reduction. The 12 steps of Alcoholics Anonymous do work well for many people. Still, people should know that there are alternatives.
Does the Sinclair Method work? What is the success rate?
You will often see a success rate of 78% quoted for TSM. That figure comes from Dr. Sinclair’s own reports on patients treated at clinics in Finland. It did not come from placebo-controlled trials, and it should be read as his account of his own program, not as a promise.
The controlled trials on the naltrexone label are more modest. They tested a daily tablet alongside other treatment, and the label describes the expected effect as a “modest improvement in the outcome of conventional treatment.” A tablet taken only before drinking is not what those trials tested.
What does success mean here? With TSM, we cannot use complete abstinence as the marker. Success means drinking less, which may be fewer drinks, fewer drinking days, and, for some people, eventually none at all.
When a doctor starts to treat patients with TSM, they see that many patients who take the tablet before every drink do cut back. Results vary, and I cannot tell you in advance whether you will be one of the people it helps.
Naltrexone is not a miracle drug. Its label calls it “only one of many factors” that determine success, and with TSM it is thought to work only on the nights when the tablet comes first.
Is it safe to tell a heavy drinker to keep drinking?
This is a good question, and doctors ask it too. Traditional thinking is that the drinking must stop first, and most rehab facilities promote complete abstinence and the 12 steps. Yet, what happens to the person who is not ready to stop? Often, they are offered nothing.
Harm reduction means to protect a person’s safety until they can get out of harm’s way. TSM does not require abstinence to begin, so it gives heavy drinkers, and gray area drinkers who binge on the weekends, a place to start. For patients who choose abstinence, naltrexone taken daily remains an option.
There is also a medical reason to prefer a gradual path. When someone who has been drinking heavily for a long time suddenly stops, alcohol withdrawal can be painful, and it can be deadly. I see TSM as a taper for alcohol, in which the drinking, and the body’s dependence on it, come down gradually.
Naltrexone does not make alcohol safe, and it does not treat alcohol withdrawal. If you drink heavily every day, do not stop all at once on your own. Stopping should be planned with a doctor.
A seizure, confusion, or hallucinations after cutting back are reasons to call 911. If you are having thoughts of suicide, call or text the 988 Suicide and Crisis Lifeline.
Is naltrexone habit-forming, and what are the side effects?
When a doctor offers a medication to help with drinking, the patient may worry about becoming dependent on the pill instead. It is a fair worry. In medicine, we sometimes call benzodiazepines, such as Valium (diazepam) and Xanax (alprazolam), “alcohol in a pill,” because they act on the same receptors in the brain that alcohol does. While a doctor may use Valium for a few days to treat acute alcohol withdrawal, a long-term prescription to replace the evening drinks is something else.
If you already take one of these medications, do not stop it suddenly because of what you have read here. A benzodiazepine must never be stopped abruptly, because sudden discontinuation can trigger seizures and can be life-threatening. Any change should be gradual and supervised by your prescriber.
Is naltrexone in that category? Not at all. Its label states that it “does not lead to physical or psychological dependence,” and there is nothing in it to get high from.
Naltrexone does have side effects. In the safety study on the label, nausea was the most common, in about 1 patient in 10, followed by headache, dizziness, nervousness, fatigue, and trouble sleeping. These tend to show up early and often pass.
The label also warns that naltrexone can injure the liver at doses several times higher than the usual one, and that it should not be taken by a person with acute hepatitis or liver failure. Your doctor may want a blood test before you start, which is not a bad idea for anyone who drinks heavily.
Naltrexone is not for anyone who takes opioids.
This is the one warning that cannot be skipped. Naltrexone must not be started by a person who is taking, or is physically dependent on, any opioid. That includes prescribed pain medication, tramadol, methadone, and buprenorphine (Suboxone).
Why not? The blocker knocks opioids off of their receptors all at once, which causes a sudden and severe withdrawal.
How severe? The label says that symptoms have usually appeared within five minutes, have lasted for up to 48 hours, and have sometimes required a hospital stay. It recommends a minimum of 7 to 10 days free of opioids before the first dose, and it warns that the risk can last as long as two weeks after buprenorphine or methadone.
So, tell your doctor about everything you take, including the pain pills left over from a dental procedure. While you are taking naltrexone, opioid pain medication may not work as expected, so every doctor, dentist, and emergency room that treats you needs to know. Never try to overcome the block by taking more of an opioid, because that can cause a fatal overdose.
What if you have been drinking to relieve pain?
Many people with chronic pain turn to alcohol for relief, and for some of them, it starts after a prescription for pain medication ends. Alcohol is a drug. Over time, it takes more and more alcohol to get the same relief, and heavy drinking combined with acetaminophen (Tylenol) can injure the liver.
Drinking is never a safe pain plan. If you have slid into nightly drinking for pain, your body has adapted to alcohol being there, which is known as physical dependence. Physical dependence is not addiction, and it is not a character flaw.
The way out should be gradual, and TSM can be that way out, as long as you no longer take any opioid at all and have passed the opioid-free days described above. The pain itself still needs a real plan. Ask your doctor about options that do not involve medication first, such as physical therapy, osteopathic manipulation, exercise, and heat.
What about Antabuse and the Vivitrol shot?
Antabuse, or disulfiram, works by deterrence. Even a small amount of alcohol on top of it produces flushing, a throbbing headache, nausea, and vomiting. A person taking it may want the drink as much as ever, and is simply afraid of it.
Naltrexone is nothing like that. Its label states that it “is not aversive therapy,” and it does not make a person sick from drinking. Instead, it works on the craving itself. There is a fuller comparison with a third medication in acamprosate vs naltrexone. If you take Antabuse now, do not test it with a drink, because a reaction can occur as long as two weeks after the last dose.
Vivitrol is an injectable form of naltrexone that lasts for a month. The marketing for Vivitrol did help to spread the word that naltrexone is a real treatment. Yet, Vivitrol is expensive, and its promotion has led to the perception that naltrexone pills are not effective.
The fact is that generic naltrexone tablets are effective and very affordable. A monthly injection also cannot be timed to the hour before a drink, and the same opioid warning applies to the shot as to the tablet.
Should you wait until more studies are done on the Sinclair Method?
No, not at all. Of course, more research should be done. However, naltrexone itself is not experimental. It is an approved medication that doctors have prescribed for decades, and what is new to most of them is only the timing. I believe that a physician should offer it now, with an honest account of what is known and what is not.
You do not have to hit bottom first, and you do not have to quit first. It is not a bad idea to talk to your doctor about TSM. Bring the real number of drinks and the full list of your medications.
How do I use the Sinclair Method?
I prescribe naltrexone tablets for alcohol use disorder and gray area drinking, by telemedicine, for patients in Florida. You do not have to stop drinking before starting treatment, and the goal belongs to you.
There is more about how treatment works on the page about The Sinclair Method for alcohol use disorder. To ask about an appointment, use the contact form.
This article is educational. It is not medical advice, and reading it does not create a doctor-patient relationship. Decisions about starting, continuing, or tapering any medication should be made with your own physician.
