The Sinclair Method | The Sinclair Method Step Three. Your Prescription for Naltrexone or Nalmefene

A description of step 3 of the Sinclair Method to beat alcoholism or alcohol use disorder using Naltrexone or Nalmafene tablets.

The Sinclair Method, Step 3, alcoholism, recover from alcoholism. Naltrexone,Nalmafene,

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Step Three. Your Prescription for Naltrexone or Nalmefene

STEP THREE: YOUR PRESCRIPTION FOR NALTREXONE OR NALMEFENE

Obtaining Your Prescription – Drinking on Naltrexone or Nalmefene is ‘Good Medicine’

Chapter 1 described how naltrexone was approved for the treatment of drinking problems by the FDA in 1994 in the United States and subsequently by medical authorities in many other countries. Back then, the World Health Organisation endorse naltrexone, and the NIAAA confirmed it was the first truly effective medication to help in the battle with addictive drinking. But it took another twelve years for the American Medical Association (AMA) to acknowledge that naltrexone should be widely used for alcoholism in general medical settings with its May 2006 publication of the results of Project COMBINE, the largest multicentre clinical trial in the history of addiction research.

Unfortunately, the fact that naltrexone is not a sufficient ingredient in itself generally remains underreported. In other words, it will not work on its own together with abstinence. Most doctors and patients assume that medications are taken or specific illnesses or conditions. Thus, aspirin helps reduce pain, antibiotics cure bacterial infections, and insulin controls diabetes. Doctors write out prescriptions for medications. Patients follow doctors’ orders and take the medications, which are presumed to have inherent healing properties. Whilst most medications – antibiotics, antihypertensives, or antidepressants – may work like magic, the patient need do little apart from taking the medication.

This is not the case with naltrexone nor nalmefene for alcohol addiction. The medication is only part of the treatment. Active drinking is required in combination with the medication to produce results. As we have seen, the scientific evidence from more than seventy published clinical trials confirms that the medication only works with concurrent drinking – according to the formula or Naltrexone or Nalmefene + Drinking = Cure.

Although pharmaceutical companies list every conceivable drug side effect for legal reasons, they characterise naltrexone as a well- tolerated, safe, nonabusable medication. Naltrexone (50mg) was first branded as Revia ™ in the United States and in several other countries. In the United Kingdom, it is branded as Nalorex ®. it is also sold under the brand name Depade ® in the United States. Other brand names for naltrexone include Naltima and Nodict (India), Narpan (Malaysia), Antaxone and Celupan (Spain), and Narcoral (Italy). The long-acting monthly injectable form of naltrexone is branded as Vivitrol ® in the United States.

The equivalent dosage of nalmefene (18mg) is branded as Selincro ® across Europe.

Naltrexone is available in time-release formulations that ensure it is released slowly and continuously into the bloodstream, and is always in the body. When this happens, the opioid receptors are blocked continually for a month or more. This procedure offers some advantages over taking pill orally, and nice results have been obtained with the monthly sustained Vivitrol ® injection. However, the long-term effects of the slow-release preparations have not been fully examine. Continual administration also prevents the use of naltrexone selectively to weaken only alcohol drinking and not other behaviours (discussed in chapter 9), as well as preventing pharmacologically enhanced learning of healthy alternative behaviours.

During Step Three, you begin thinking of drinking alcohol while on naltrexone or nalmefene, as being ‘good for me’ or at least ‘necessary for me to get better’. At first, it may feel strange, but you will soon get used to it. Remember, the combination of the two – Naltrexone or Nalmefene + Drinking – is your medicine, your ultimate cure and freedom from your addiction. But doing either alone – drinking without taking naltrexone or nalmefene or taking naltrexone or nalmefene without drinking – will do nothing to help reduce craving and break your addiction.

Here are some reminders. Naltrexone or Nalmefene + Drinking alcohol over three to four months produces:

Decreased craving for alcohol without having to stop cold turkey.
Reduced interest in and obsessive thoughts about drinking.
Drinking reduced to within normal safety limits – no more than twenty-four drinks per week for men and no more than five drinks on a single occasion, or no more than sixteen drinks per week for women or four drinks on one occasion. (Upper limits are set by different agencies; these limits are derived from the World Health Organisation.)
The ability to choose to abstain totally – but only after an average of three to four months on the Sinclair Method.
Automatic and gradual withdrawal and detoxification from alcohol.
Setting your own goals – total abstinence or drinking within safe limits.

What Does It Feel Like to Drink While Taking Naltrexone or Nalmefene?

If you took naltrexone or nalmefene without drinking, your would feel about as much as you would if you took a multivitamin – virtually nothing.

Fewer than 10% of patients reported temporary nausea in clinical trials in which it was given to abstinent patients. It produced even fewer side effects in patients who were still drinking. The medication is not psychoactive, and it will not make you feel high or low. Naltrexone or nalmefene does not bring relief from alcohol craving like a painkiller relieves a headache. Some patients report they do not get a ‘buzz’ from the first drink when they begin drinking while taking naltrexone or nalmefene. However, even when you do take it together with alcohol, you do not subjectively feel it working in your system.

One of the nice features of naltrexone, nalmefene and other opioid antagonists is that the endorohin system they block is relatively unimportant most of the time. Endorphins are involved in many forms of reinforcement, but usually as just a backup or shortcut system. Their role as painkillers may be important in the wild, where animals often have to function despite severe injury in order to survive, but in our modern world, we are seldom faced with such challenges. Other neurochemicals that modulate behaviour, such as dopamine, serotonin, and epinephrine, are critically involved in the regulation of vast numbers of activities, and one must be very careful with drugs that alter these systems. With the endorphin system, however, most people can’t even tell if it has been blocked by an antagonist such as naltrexone. Indeed, that has been tested in some of the double-blind clinical trials in order to demonstrate that the patients really could not tell if they had been given an opioid antagonist or a placebo.

Remember, naltrexone or nalmefene by themselves will not reduce the craving or de-addict you in fifteen minutes, fifteen days, or fifteen years. You should be aware of false claims on the Internet that naltrexone can abolish your craving within fifteen minutes. As we saw in chapter 3 on the scientific evidence behind the Sinclair Method, naltrexone or nalmefene is only effective if combined with drinking over the course of at least three to four months. Extinction takes time and requires active drinking together with naltrexone or nalmefene before full de-addiction can happen.

Alcohol Abuse and Addiction Are Not Rational

Some people have questioned whether patients would actually take naltrexone or nalmefene. If they block the ‘pleasure’ from drinking, a rational patient would simply stop taking the medication in order to get pleasure again from drinking.

First, let’s start with an established fact. Compliance has been extraordinarily good with the Sinclair Method. More than 85% of the alcoholics being treated with naltrexone do indeed take their medication, even though they have been told that it blocks initial euphoria from alcohol.

That is not rational, you might complain. No, it is not, and the reason is that alcohol abuse is not a rational behaviour chosen logically for its ability to produce euphoria. Studies of human social drinkers show that euphoria is only occasionally increased alcohol. If you are in a melancholy mood, red wine will make you bluer. If you in a party mood, you will fly through the air on bubbles of champagne. If you are feeling frustrated, you may become aggressive – hence, the violence associated with drinking and crime. If you are in a hospital gown in a stainless steel laboratory at nine o’clock in the morning with nothing to eat or drink, alcohol will not produce euphoria – as was demonstrated in one PET brain scan study in Finland on the effects of alcohol. The study demonstrated nicely some of the immediate effects of alcohol on the brain, and it showed that an opioid antagonist blocked these effects. The researchers had hoped to measure if it was blocking euphoria as well, but failed because the alcohol did not produce any significant increases in euphoria under stark laboratory conditions.

Among alcoholics, there is very little – if any – pleasure obtained from drinking, and certainly not enough pleasure to compensate for all the pain they get from their continued abuse of alcohol. Alcoholics drink because they have become wired to drink. There is no rational reason for choosing to drink because they do not ‘choose’ to drink, any more than you choose to lift your leg when the doctor taps your knee. You are wired to produce the knee-jerk reflex, and the alcoholic has become wired to produce the drinking reflex.

So, yes, naltrexone or nalmefene may partially block the pleasure – if any – from drinking. But pleasure is not why alcoholics continue drinking. Consequently, the blocking of pleasure from alcohol stopped few patients from taking their naltrexone or nalmefene. If they had been told to abstain from drinking, compliance would have been much more difficult. Alcoholism, by definition, is difficulty in abstaining from alcohol. And clinical trials that have instructed patients to abstain have met with more problems with compliance. However, being told to take a pill before drinking is an easy command to obey.

The pleasure from alcohol may be unimportant for the alcoholic, but the overall pleasures in life are important. Many behaviours are reinforced by endorphins, and we would not want to lose these other joys in life. As a solution for this problem, the Sinclair Method uses a process called selective extinction that removes the behaviours related to alcohol craving and abuse but supports and strengthens the other behaviours reinforced by endorphins. (This will be discussed in chapter 9 in the section titled Selective Extinction: How to maximize Your Results.)

Your subjective sensations, feelings, and emotions hardly change when you drink while taking naltrexone or nalmefene. However, the pathways controlling your drinking are incrementally weakened each time you do it. This occurs at the microscopic level of trillions of connections between neurons in the brain. Just as you cannot feel the metabolic processes in your liver or kidneys, you do not feel the de-addiction process as your nervous system is restored to normal.

As you drink on naltrexone or nalmefene, you will not be aware of the neural super-highways being weakened and cut back into their original condition. The process amounts to the gradual but steady weakening of the addictive circuitry wired throughout your brain and nervous system. As you proceed to drink while taking naltrexone or nalmefene, your brain is no longer being enforced by endorphins, This produces pharmacological extinction – Sinclair’s amazing discovery – which automatically weakens the wiring causing your addiction. De-addiction happens slowly but surely with the research showing that the more often you drink on naltrexone or nalmefene, the more you weaken your addiction. One could not ask for an easier, more elegant, or dignified solution to addictive drinking – you literally ‘Drink Your Way Sober’.

Working with Your Doctor Toward Your Cure

Regaining control over your drinking means taking the initiative as soon as possible. You need to enlist the support of a physician to prescribe naltrexone or nalmefene. Your main objective in Step Three is to obtain your prescription so you can follow the simple yet powerful formula of Naltrexone or Nalmefene + Drinking over three to four months = Cure in Step Four.

Your physician does not have to instruct you to carry on drinking while on the medication. He or she simply instructs you that, if you are going to drink, always take your medication before you do. An additional instruction would be ‘Do not take your medication on days when you are not drinking’ because naltrexone or nalmefene have no de-addictive action on their own.

The question of whether it is unethical for physicians to tell you formally to drink, especially if you are addicted to alcohol, is easily resolved. If you already have an addictive drinking problem, you will drink anyway, no matter what anyone, including yourself, tells you to do. In this way, your doctor can safely say, ‘I do not advise you to drink but, if and when you do drink, make sure you take naltrexone, or nalmefene, beforehand.’

The aim of the Sinclair Method is to reduce craving and drinking to safe levels. Because withholding an effective treatment is not in the patient’s best interests, in light of the research supporting extinction treatment, it may also be argued that it is unethical to instruct patients to take the medication in the wrong way – together with abstinence. Success is accomplished by drinking while taking the medication in order to reset the wiring in your brain, driving the craving and addiction back toward zero. Remember, as we saw in chapter 3, the research on the opioid antagonist medications (naltrexone, nalmefene, naloxone) proves that the addictive wiring, acquired over many years of drinking, is restored functionally to the state it was in before the addiction took root.

If you have a trusting relationship with your doctor, you might wish to refer him or her to chapter 17 (‘For Medical Professionals’) and to the research articles listed in this book – especially if your physician is unfamiliar with the way naltrexone or nalmefene works with the Sinclair Method. You might also want to inform your physician that pharmacological extinction is part of mainstream medicine and that it has been scientifically substantiated over the past thirty years. Now it has the backing of more than seventy published clinical trails (listed in the annotated bibliography). You may also wish to inform your doctor that naltrexone was approved by the FDA in 1994, and endorsed for use in alcoholism by the WHO (1994) and by more than twenty leading alcohol researchers in the United States, who published their findings of Project COMBINE in the Journal of the American Medical Associations in 2006 (Anton, O’Malley et al., 2006).

Because naltrexone and nalmefene are opioid antagonists, it cannot be abused. You cannot get high from it as you can with tranquilisers or many other prescription drugs. Naltrexone and nalmefene pose no addictive risks. Therefore, physicians can feel safe about prescribing it in general medical settings.

The normal dose is 50mg of naltrexone to be taken an hour before drinking alcohol. Some doctors recommend that you begin treatment with half the normal dose (25mg) by breaking the tablet in half. This is recommended to help you get used to taking the medication on the first two or three drinking sessions.

The normal dose of nalmefene is 18mgs. The tablet cannot be broken in half.

Your doctor will require a blood tests before prescribing naltrexone to check for cases of existing liver damage. The reason for this is that one study using massive doses of naltrexone (3oo mg daily) found they were stressful to the liver. There is no evidence that any lower doses of naltrexone stress the liver. Moreover, one of the common measures showing the effectiveness of naltrexone is that the same measures of liver damage improve as a result of the treatment. Nevertheless, it was felt that naltrexone should not be given to people who already had severe damage to their livers, so a liver function test is needed, and a small percentage of patients will not be able to start naltrexone. Although 100-150 mg doses are occasionally prescribed in special cases, you must stay within the recommended dosage and not take more than the usual 50 mg dose of naltrexone without consulting your physician – taking a higher dose will not speed up your three to four month de-addiction process. A dose of 50mg should block 100% of the opioid receptors for most people; doses of 100 or 150 mg still only block 100% of the receptors, and thus do not accelerate the treatment.

One of the advantages of nalmefene, the sister compound to naltrexone, is that it is not metabolised in the liver, so doctors will not require liver function tests before prescribing it.

If you are a weekend drinker, only take your medication on weekends. Do not take it during the week, unless of course you find yourself drinking during the week. If you drink ever day, take your medication every day. If you drink six days a week, take it six times during the week, one hour before you have a drink. If you find you have the urge to drink and have accidentally had a drink without taking your medication, take your tablet immediately. Always keep the medication with you. Some people keep their medication on their person for years, even after choosing to abstain completely – just in case.

Naltrexone or Nalmefene + Drinking = Cure

Don’t be alarmed if you come across misconceptions about taking the medication. Many people assume that naltrexone and nalmefene should be used with abstinence. Such misconceptions are often understandable. While they may be unscientific, they seem to make good common sense – ‘Take this pill for that problem’ is the way in which we have become accustomed to thinking about medication in general. Most of us are taught to think of tablet-taking as a passive process. We take tablets for headaches and the headaches go away – there is nothing more we have to do. They work magically to kill pain, put us to sleep, cure infections, and restore normal heart rhythms – all by themselves.

The administration of naltrexone or nalmefene is a profoundly different procedure. It requires continued drinking on the medication. Your de-addiction is an active process. You actively take naltrexone or nalmefene and then you actively drink alcohol. Remember, your de-addiction is not instantaneous. It takes time to de-addict yourself. But if you follow the formula of Naltrexone or Nalmefene + Drinking = Cure, your chances of beating the bottle – or regaining control over alcohol – are in the region of 80%.

The main objective of Step Three is to secure your prescription for naltrexone or nalmefene. In practise, most physicians in the United States will be pleased to write you a prescription for naltrexone – especially because the AMA published the results of Project COMBINE in May 2006 endorsing the use of naltrexone for alcoholism in general medical settings.

However, if for some reason your doctor feels that the Sinclair Method is beyond his or her expertise, do not be disheartened. Your doctor may refer you to another physician or you can be proactive and find one who is more open-minded, someone who will take the time to consider the solid science behind the Sinclair Method. Please refer to chapter 17 (‘For Medical Professionals’) and to www.TheCureForAlcholism.com for updates.

CONTENT IS INFORMATION ONLY AND NOT ADVICE

Legal Disclaimer Notice: The rules for obtaining opioid antagonist tablets such as Naltrexone vary in different parts of the world so always consult your Doctor. Some countries require a prescription while in others the medication can simply be purchased over the counter in a Pharmacy. There are often different terms used when this solution is used as treatment. For example although not generally referred to as the Sinclair Method, the method has now been approved for use with nalmefene (Selincro®) in all of the European Union member states. There are many different methods to help somebody stop abusing alcohol and your Doctor may advise you that an alternative method would be more suitable in your case.

The information provided on this site is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. You should consult with a healthcare professional before taking any medication, or if you have or suspect you might have a health problem. You should not stop taking any medication without first consulting your physician.