The Sinclair Method

By life-j

One of the things we AAs read from the Big Book as if it were an ever-lasting truth, though it was written in 1939:

“Physicians who are familiar with alcoholism agree there is no such thing as making a normal drinker out of an alcoholic. Science may one day accomplish this, but it hasn’t done so yet.”

And it has been a well kept secret that science began to do just that around 1978.

There is still general agreement that it is way preferable for alcoholics to stop drinking altogether, but to the extent this cannot seem to be accomplished, moderated drinking would be preferable to continued out-of-control drinking. However, in this article we will not be talking about “Moderation Management”, the program that claims that people can moderate their drinking by sensible application of willpower, but moderation with medications which have been around for decades called Naltrexone and Nalmefene.

When used according to Dr. Sinclair’s method there appears to be some extent of success with 80% of those who take it, such that half of those wind up stopping drinking altogether, and half cut their drinking in half, or better.

Naltrexone and Nalmefene are opioid antagonists.

In our brain chemistry when we take a drink or do something else with which we associate pleasure, endorphins are released. There are neural receptors that fire when endorphins attach to them, or when an opiate does, and this completes the experience of pleasure. Naltrexone is designed such that it will attach to those receptors, but not fit properly, and therefore the receptors will not fire, and no sense of pleasure occurs. Thus, when Naltrexone is taken, say, an hour before drinking or taking a drug, it has time to block all receptors in this manner so that alcohol or drugs will give no pleasurable effect, though they will still both get a person drunk/high, and will result in the usual incapacitating physical effects of alcohol such as impaired coordination when drunk, etc.

Dr. John David Sinclair was an American doctor (died earlier this year) who started studying alcoholic behavior in both laboratory animals, and people in the late 70s. He has mostly worked in Finland where he received support for his research. He has formed the theory that alcoholism is a learned behavior much along the lines of Pavlovian conditioning. Drinking initially causes pleasure, even when, as is the case with many of us, in reality it just takes discomfort, social and otherwise, away, and that is experienced as pleasurable. Then every time this person takes a drink the pleasure principle is reinforced. Later in a person’s drinking career, when physical dependency on alcohol is developed, a similar phenomenon asserts itself. The anticipation of pleasure still reigns. Drinking takes away the jitters, and that is experienced as pleasurable, even though there is no genuine pleasure, and we know very well that it only feeds into a vicious circle.

One of the reasons why Naltrexone has not found more use is that, according to Dr. Sinclair, it has been used wrong.

Naltrexone is an odd sort of medication. It appears to modify behavior. Actually any pleasurable behavior which releases endorphins is liable to get modified by it. Thus when taken in the wrong manner, it can lead to loss of pleasure in sex, eating, exercise or any other activity perceived as pleasurable, and thus a decrease in such activities.

Dr. Sinclair’s assertion which is slowly gaining acceptance is that Naltrexone must be taken an hour before a person with reasonable certainty expects to drink, and only on days when he expects to drink. It will then, after a few months’ use generally result in greatly decreased drinking, or stopping altogether. The medication, when taken according to this recommendation will allow the brain to recondition itself, and the craving for alcohol, and the pleasure from drinking will fade away. This process is called pharmacological extinction.

The officially recommended use since Naltrexone was authorized by the FDA in the mid-90s has been that the alcoholic takes it every day, and abstains from drinking. In clinical trials this had even less success than the placebo control group. However, there were some in the abstaining group who had success with this treatment. Turned out those had been cheating, and drinking anyway. Those who actually abstained were more likely to go drinking with a vengeance after the trial.

Dr. Sinclair reasoned that the medication needed to interact with actual drinking behavior to be successful. In order for the person to experience decreasing pleasure in drinking he had to actually drink. By abstaining all he would do is to increase his craving, and as we know, for some the craving can be horribly persistent. Worse yet, by abstaining from drinking and taking the medication, the medication would instead likely affect the experience of any other pleasurable, endorphine releasing activities, and make the person loose interest in those, rather than in drinking, thus making life seem ever more bland.

The benefits from taking naltrexone with drinking vs. abstinent is shown in the following figure:

Sinclair-png-image

This bar graph is from a 32 week study, so the expression “never relapsing” should be taken with a grain of salt. However the comparison is otherwise clear. Inserts with the Naltrexone medication still recommend abstinence, something that would need to be changed if this medication is to ever be used effectively.

There are factors that work against this. First of all, drinking is dangerous for an alcoholic. 10% of those who took the medication showed no positive response at all, and another 10% were not able to follow directions sufficiently to have any benefit from it. Of the 80% that would eventually show significant results, the initial phase of the program still poses significant risks. In the very early phase the medication does not yet have much effect, and the drinking behavior is as risky or even more risky than it would be without the medication. Even once the medication starts having an effect, but while a person’s drinking is still rather on the heavy side, it is only the pleasurable effects of alcohol that are lessened. The impairment of motor skills, reaction time, social interaction, and judgment remains as strong as without the medication, so there is still significant risk of problematic outcomes during the first few weeks of treatment. It is small comfort that someone was on his way to sobriety if he manages to cut the hopes short with a fatal car crash or some other unfortunate event during those first couple of weeks.

Thus many doctors will be reluctant to recommend that a patient should “drink himself into sobriety”, and insurance companies will be reluctant to accept such a treatment, none the least because during the last half century AA’s assertion that only complete abstinence works, has been a major guiding force on alcohol policy.

Of course AA itself will be very reluctant to embrace the Sinclair Method, mostly out of contempt prior to investigation.

And while some sober alcoholics who have not quite embraced their sobriety may fantasize that here is an opportunity to go drink just one more time in order to get sober, psychologist Roy Eskapa cautions that it would be both dangerous and pointless to let an already abstinent person go through the Sinclair Process.

In Roy Eskapa’s book Cure for Alcoholism we read:

David Sinclair reported on the lasting benefits of naltrexone three years after the start of treatment, in which patients continued to take naltrexone an hour before drinking.

The patients did not take the medication on days when they were not drinking. The patients’ craving, drinking levels, and liver damage markers were all way down. Indeed, these patients were drinking and craving alcohol less after three years than they had been after the first five months of treatment.

Traditional abstinence-based alcoholism treatments had always found that the results were best at the beginning of treatment, and then gradually, week after week, the patients would relapse and the drinking would increase to the level it had been before treatment. Pharmacological extinction produces exactly the opposite pattern, as shown by this three-year follow-up study. The drinking and craving is highest in the first weeks of treatment, but becomes progressively lower as the weeks on treatment progress because each intervening episode of drinking while on naltrexone was one more extinction trial. In other words, the more often people drink while on naltrexone, the less they will want to drink.

I contacted Dr. Roy Eskapa, and he informed me that no other studies have yet been performed on the long term results, but that one problem associated with long term treatment is that patients eventually get too lax about taking the medication before drinking. If people ever drink without first taking Naltrexone they will relearn the drinking behavior.

Patients need to keep Naltrexone with them at all times for the rest of their lives to the extent there is likelihood they will drink, so that they can take a pill an hour before drinking, if they should do so. This may seem burdensome, and is one major reason why people who have undergone the Sinclair Method relapse into their old patterns of drinking, but it is not really any more burdensome than going to AA meetings for the rest of our lives, something many alcoholics in AA similarly fail to do, and while this does not automatically make them relapse it does put them at greater risk of doing so.

Nalmefene is not yet entirely approved by the FDA as a treatment for alcoholism, but has been approved by the EU and in use in Great Britain for a couple of years. Though also metabolized by the liver it is not as hard on it. Nalmefene absorbs better when taken orally, has longer duration of antagonist action, and more competitive binding with opioid receptor subtypes that are thought to reinforce drinking. However, it is still under manufacturing patent, and therefore relatively expensive.

Naltrexone patents have expired, so it is now available as a generic. However, there are more side effects from its use than from Nalmefene, though rarely severe, including some nausea, and in large doses it can be hard on the liver, though in the doses prescribes for alcoholism, 25 mg the first two days and 50 thereafter, it is typically not an issue since the benefit of not drinking large amounts of liver damaging alcohol will soon outweigh the slight tendency toward liver damage from naltrexone.

A webpage by National Institute of Health describes a major recent study with Nalmefene, named ESENSE. Here are some of its conclusions:

…. This approach, better adapted to patients who do not wish (or cannot) remain totally abstinent is able to considerably reduce the damage related to alcohol consumption. This objective, which is more accessible and better accepted because it more closely corresponds to the patient’s preference, can enable the patient to modify his/her attitude in relation to alcohol dependence. This approach would encourage the patient to seek medical attention and would increase the percentage of patients accessing care….

… Patients are more likely to achieve their objective that they have chosen themselves as opposed to an objective imposed by the physician. Patients who choose abstinence more often achieve abstinence, while patients who choose reduction of consumption more often achieve this objective. As-needed treatment gives patients a more active role in management of their disease by making them more attentive to the quantity of alcohol consumed and the situations in which they drink. General practitioners, who often feel relatively impotent when the only objective is abstinence, could feel more confident about helping their patients. Reduction of consumption can be either an intermediate objective until the patient understands and accepts the need for abstinence, or, in less severely dependent patients, a realistic long-term objective.

National Institute of Health

I looked at length for negative reviews of these medications, and did not find much other than where it was associated with treatment in combination with abstinence.

Of course this sort of treatment is quite contrary to AA’s central principle that only total abstinence will work for an alcoholic. And for me, personally, anything else is indeed hard to imagine. I know how addictive my personality is. My obsessive need to drink alcohol is long gone, but I just devoured a box of cookies in the same manner I used to drink. The thought of the need to drink simply disappearing from taking a pill is quite foreign. And there is an element of AA’s philosophy which is so, eh, what should I call it, “protestant”? – that taking a pill would be cheating. Sobriety must come through suffering, self-flagellation with the 4th step, and making amends, AA is full of the Christian virtues of guilt, shame, remorse, confession, asking for forgiveness and help becoming a better person, not from just taking a pill.

I’m not here to put AA down, only to take a fair look at all the options. After all, our primary purpose is to help the still suffering alcoholic. Personally I have gained a lot from working the 12 steps, and even more from the fellowship of AA. But it is a religion. Every approach which leans more toward a scientific approach is worth investigating.

In other parts of the world good results have been achieved for alcoholics with Cognitive Behavioral Therapy, and I can imagine that if that were paired up with opioid antagonists we’d have a very powerful tool for stopping out of control drinking, but if all we could accomplish in many of the cases would be moderated drinking, that would still be way better than the alternative which is out of control drinking. I know AA says that moderated drinking is not possible except as a strenuous interlude. The results from opioid antagonist use seem to suggest that AA may not have it all right.

However, most of us started drinking for a reason. Low self-esteem, childhood traumas, whatever – those reasons are still there, buried inside. And the pills won’t address those underlying reasons. Therapy can work for that. We know that using the 12 steps can work for that. Having a tribe of like-minded people for mutual support can work for that, it’s probably the most important of all.

But it all starts with putting the plug in the jug. Keep your hats on. Opioid antagonists probably won’t help any alcoholic drink like a gentleman, whether man or woman. But they do indeed seem promising. If they can help him cut way back or even quit entirely, he may get clearheaded enough to have a look at his options. They may help save his life long enough to where he can do more with it, and rebuild an enjoyable life, whether in the long run he will find a reason to come to AA or not.


Postscript, Additional Reading and References

It has been a while since I wrote this article, here is some further information, contacts with the people involved and links to various resources: Postscript, Additional Reading, and Resources


 About the Author

life-j got sober in Oakland in 1988. He’s been involved in service work of every kind ever since, but now thinks the most important work is to help atheists and agnostics feel safe and welcome in AA. He’s spent parts of his life as a building contractor, part as a technical translator, and has dabbled a bit in art work and writing. life-j is now semi-retired and since 2002 has lived – along with his sweetie, and his dog, chickens, garden and apple trees – on a five acre homestead in a Northern California mountain village.

He has written a number of articles for AA Agnostica, including:

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Brian connell
Brian connell

Brilliantly written, thankyou for making the ldn process even clearer with no ulterior motives, many thanks.

Regards brian c.

David Harris
David Harris

I have been involved in alcoholism treatment both in a personal and professional capacity for thirty years. The core problem in this field is that doctors have no tools for diagnosing a medical condition underlying alcoholic addiction. Alcoholics self-diagnose. DSM-5 uses symptoms and consequences to diagnose alcohol use disorder. Therefore any talk about whether this medication is successful for “alcoholics” is untethered to any factual diagnosis of a disease. In fact, it avoids diagnosis altogether and just relies on anecdotal evidence of recovery. It is a commercial product and its proponents engage in advertising and promotion over social media. It… Read more »

life-j
life-j

Hmm, Naltrexone IS a generic, and therefore no pharmaceutical company has any interest in promoting it, or any interest in doing double-blind scientific studies. Why that was not done when it was new is a good question. But since the drug appears to have significant effectiveness, and after all Dr Sinclair at least did some studies of its short-term effectiveness, for the rest I guess we have to rely on the anecdotal evidence. We can’t just dismiss its use just because there is no big money to be made on it anymore. Which makes it seem like there is something… Read more »

life-j
life-j

Scott, thanks for checking in, and please keep us posted. A lot of people take naltrexone the “FDA way” which does not seem to work. So you taking it the “Sinclair way” is really important for us to hear about.

Scott C
Scott C

I’ve been in and out of AA with multiple four year, two year and one year periods of sobriety for 25 years. Most recently I had a relapse after a year and went to rehab for the sixth time and slipped again a month after getting out. It was by complete accident that I came across TSM while watching the documentary 13th Step, which prompted further investigation into the 3c website. I happened to have a script for Naltrexone and am on my second day of this treatment. Last night I tried it the first time and found myself limiting… Read more »

Leah Johnson
Leah Johnson

I acknowledged I was an alcoholic 5 years ago. Since then I have been to Residential Treatment programs four times, and have attended many AA meetings. I was successful at staying abstinent for almost 2 years, before I relapsed again. Since then, my longest term of sobriety has been 4 months. Last month I got the Vivitrol shot. I realize this isn’t quite the Sinclair method, but I had tried taking Naltrexone orally before, and had always eventually put the pills down so I could drink again (because what’s the point of drinking without that “million dollar” feeling?). With the… Read more »

life-j
life-j

Leah, thanks for sharing your experience with Vivitrol. We need more testimony about how it all actually does work.

And I can see how it can be a compliance issue when one wants to drink. Same as that people don’t call a friend in the program before they go drinking. When a person has made up their mind, the last thing they’re going to do is call someone to talk them out of it. Glad to see that Vivitrol has some effect on that problem.